VGX Pharmaceuticals, a biopharmaceutical company that is developing DNA vaccines for cancer and HIV and therapeutics for other diseases, announced today the results of a Phase I single ascending dose (SAD) study that demonstrated that its lead anti-inflammatory compound, VGX-1027, was generally safe and well tolerated in humans. As a result, VGX Pharmaceuticals and VGX International, a Korean affiliate that is jointly developing VGX-1027, have commenced a multiple ascending dose (MAD) study. VGX-1027 is an orally active, small molecule compound that has shown preclinical efficacy against various inflammatory diseases including rheumatoid arthritis (RA) and Type 1 diabetes (T1D).
VGX-1027 is the first of a new class of immune modulators that inhibits the production of several pro-inflammatory cytokines responsible for the damaging effects of inflammatory diseases. Preclinical studies have shown that VGX-1027 is effective in inhibiting these cytokines in cell cultures. They have also demonstrated the product's efficacy in animal models for several diseases including RA, T1D, colitis, and uveitis. Its mechanism of action includes the inhibition of NF-kB and the early transient inhibition of P38 MAP kinase signaling pathways.
Inflammatory diseases including RA, T1D, psoriasis, and colitis represent major medical problems. In the U.S. alone, over 2.7 million people suffer from rheumatoid arthritis. An additional 1 million Americans suffer from type 1 diabetes, which is fatal if untreated.
Several blockbuster therapeutic agents, primarily biologics, dominate the multi-billion dollar RA drug market. However, these agents require parenteral (e.g. such as intravenous) delivery. There are few treatment options available for T1D patients other than insulin, which requires daily injections. VGX-1027 is being investigated as an oral therapeutic.
"VGX looks forward to the results of the MAD studies for VGX-1027. Successful completion of the MAD studies would allow initiation of two Phase II studies: one for RA patients, to be conducted by VGX Pharmaceuticals, and one for T1D patients, to be conducted by VGX International," stated Dr. J. Joseph Kim, President and Chief Executive Officer.
About VGX International
More information about VGX International can be found at vgxi.
About VGX Pharmaceuticals
More information about VGX can be found at vgxp.
VGX Pharmaceuticals
воскресенье, 31 июля 2011 г.
четверг, 28 июля 2011 г.
Knee injury in women soccer players linked to early osteoarthritis
One of the fastest growing team sports in America, particularly on college campuses, is women's soccer. Of the more than 17 million players participating in organized soccer nationwide, 7 million are female. While offering an equal opportunity playing field for student athletes, soccer has one unfortunate gender bias: women are more susceptible to knee injury. One of the most common is tearing of the anterior cruciate ligament (ACL)--the ligament in the center of the knee that provides stability. In Sweden, where soccer is wildly popular and women have a shot at playing in a professional league, the risk of ACL injury is 3 to 4 times higher per game hour for young female players than for their male counterparts.
As too many soccer players know, tearing this pivotal ligament brings immediate pain and swelling, followed by a nagging fear of the knee suddenly giving-way. A recent study, published in the October 2004 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis), provides compelling evidence of serious risk of knee osteoarthritis (OA) and potentially crippling long-term consequences of a torn ACL for young female athletes. Conducted by a team of researchers at Lund University Hospital, and supported, in part, by the Swedish Soccer Federation, this study focused on 103 female soccer players, between the ages of 26 and 40, who had each suffered an ACL injury 12 years earlier, when they were between the ages of 14 and 28.
Each woman consented to knee radiographs, as well as answered questionnaires about her knee-related quality of life. More than half of the women were assessed as having OA of the knee, accompanied by persistent pain and functional limitations. What's more, 60 percent of the players had undergone reconstructive surgery of the torn ligament soon after sustaining their injury. Using various analyses, the researchers found that surgical reconstruction had no significant effect on knee pain or disabling symptoms. The surgical techniques used today for this injury might be more effective in preventing OA, but this has not yet been proven in scientific studies.
The study's leading researcher, L. S. Lohmander, M.D., Ph.D., describes the very high prevalence of pronounced OA among these young ACL-injured women as "alarming," with serious implications for their future. "For many of these women, the OA disease process can be expected to progress over time and the need for an osteotomy or knee arthroplasty may arise well before the age of 50 years in many of these subjects," Dr. Lohmander speculates. "Although joint replacement may be an efficient treatment for knee OA, the risk of aseptic implant loosening and revision is more than 3-fold higher in the patients operated on while younger than age 65 years, than if older than 75 years."
The first long-term study of the risk and complications of OA linked to this common and serious knee injury specifically among women soccer players, its findings emphasize the need for improved efforts at prevention and treatment of this torn ligament. "Randomized, controlled trials are needed in which different surgical techniques and rehabilitation protocols are compared directly with the best nonsurgical treatment," Dr. Lohmander concludes.
Article: "High Prevalence of Knee Osteoarthritis, Pain, and Functional Limitations in Female Soccer Players Twelve Years after Anterior Cruciate Ligament Injury," L. S. Lohmander, A. Ostenberg, M. Englund, and H. Roos, Arthritis & Rheumatism, October 2004; 50:10; pp. 3145-3152.
Contact: Amy Molnar
amolnarwiley
John Wiley & Sons, Inc.
As too many soccer players know, tearing this pivotal ligament brings immediate pain and swelling, followed by a nagging fear of the knee suddenly giving-way. A recent study, published in the October 2004 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis), provides compelling evidence of serious risk of knee osteoarthritis (OA) and potentially crippling long-term consequences of a torn ACL for young female athletes. Conducted by a team of researchers at Lund University Hospital, and supported, in part, by the Swedish Soccer Federation, this study focused on 103 female soccer players, between the ages of 26 and 40, who had each suffered an ACL injury 12 years earlier, when they were between the ages of 14 and 28.
Each woman consented to knee radiographs, as well as answered questionnaires about her knee-related quality of life. More than half of the women were assessed as having OA of the knee, accompanied by persistent pain and functional limitations. What's more, 60 percent of the players had undergone reconstructive surgery of the torn ligament soon after sustaining their injury. Using various analyses, the researchers found that surgical reconstruction had no significant effect on knee pain or disabling symptoms. The surgical techniques used today for this injury might be more effective in preventing OA, but this has not yet been proven in scientific studies.
The study's leading researcher, L. S. Lohmander, M.D., Ph.D., describes the very high prevalence of pronounced OA among these young ACL-injured women as "alarming," with serious implications for their future. "For many of these women, the OA disease process can be expected to progress over time and the need for an osteotomy or knee arthroplasty may arise well before the age of 50 years in many of these subjects," Dr. Lohmander speculates. "Although joint replacement may be an efficient treatment for knee OA, the risk of aseptic implant loosening and revision is more than 3-fold higher in the patients operated on while younger than age 65 years, than if older than 75 years."
The first long-term study of the risk and complications of OA linked to this common and serious knee injury specifically among women soccer players, its findings emphasize the need for improved efforts at prevention and treatment of this torn ligament. "Randomized, controlled trials are needed in which different surgical techniques and rehabilitation protocols are compared directly with the best nonsurgical treatment," Dr. Lohmander concludes.
Article: "High Prevalence of Knee Osteoarthritis, Pain, and Functional Limitations in Female Soccer Players Twelve Years after Anterior Cruciate Ligament Injury," L. S. Lohmander, A. Ostenberg, M. Englund, and H. Roos, Arthritis & Rheumatism, October 2004; 50:10; pp. 3145-3152.
Contact: Amy Molnar
amolnarwiley
John Wiley & Sons, Inc.
понедельник, 25 июля 2011 г.
Actemra(R), A Humanized Anti-Human IL-6 Receptor Monoclonal Antibody, Filed For Rheumatoid Arthritis In Japan
Chugai Pharmaceutical Co., Ltd. and F. Hoffmann-La Roche Ltd. announced today that the humanized anti-human IL-6 (interleukin-6) receptor monoclonal antibody, Actemra(R) [ generic name: tocilizumab (genetical recombination) ] was filed for the additional indication of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis, to the Japanese Ministry of Health, Labour and Welfare.
Rheumatoid arthritis is a systemic inflammatory disease in which the cause is unknown. The main symptoms are multiple joint inflammation and progressive joint damage. In Japan, it is estimated that approximately 330 thousand patients are undergoing treatment. Since the majority of patients are females in their 40s and 50s, the disease is causing serious psychological and social problems not only for the patients but also for their families, and a measure to counter the disease is seriously needed. Systemic-onset juvenile idiopathic arthritis is one form of rheumatoid arthritis in children, and it is estimated that there are approximately 1,700 patients in Japan*. The main symptoms are joint involvement, remittent fever and rheumatoid rash. Patients are often forced to spend a long time fighting against the disease, causing various difficulties in school life and continuing into adulthood for employment.
Actemra(R), created by Chugai in collaboration with Osaka University, utilizes genetic recombinant technology to produce monoclonal antibody from mouse anti-IL-6 receptor monoclonal antibody. It works by inhibiting IL-6 biological activity through competitively blocking the binding of IL-6 to its receptor. Chugai filed the application with the two phase III studies conducted in Japan to gather data on efficacy and safety.
Actemra(R) was launched in June 2005 in Japan as a therapy for Castleman's disease**, following approval in April, and is now in preparation for filing the additional indication of rheumatoid arthritis. Outside of Japan, phase III clinical trials in rheumatoid arthritis are going on in 41 countries worldwide including co-development between Chugai and Roche, and Roche is planning to file the application in Europe and in the US in 2007.
* Estimated by using the incidence and prevalence rate derived from a field survey on "Medical Care of Juvenile Idiopathic Arthritis and Improvement of Quality of Life, 2001," combining with the population statistics of 2003 (Ministry of Health, Labour and Welfare).
** The approved indication is "improvement of various symptoms (e.g. general malaise) and laboratory findings (e.g. increased C-reactive protein, fibrinogen, and erythrocyte sedimentation rate, decreased haemoglobin and albumin) associated with Castleman's disease."
chugai-pharm.co.jp
Rheumatoid arthritis is a systemic inflammatory disease in which the cause is unknown. The main symptoms are multiple joint inflammation and progressive joint damage. In Japan, it is estimated that approximately 330 thousand patients are undergoing treatment. Since the majority of patients are females in their 40s and 50s, the disease is causing serious psychological and social problems not only for the patients but also for their families, and a measure to counter the disease is seriously needed. Systemic-onset juvenile idiopathic arthritis is one form of rheumatoid arthritis in children, and it is estimated that there are approximately 1,700 patients in Japan*. The main symptoms are joint involvement, remittent fever and rheumatoid rash. Patients are often forced to spend a long time fighting against the disease, causing various difficulties in school life and continuing into adulthood for employment.
Actemra(R), created by Chugai in collaboration with Osaka University, utilizes genetic recombinant technology to produce monoclonal antibody from mouse anti-IL-6 receptor monoclonal antibody. It works by inhibiting IL-6 biological activity through competitively blocking the binding of IL-6 to its receptor. Chugai filed the application with the two phase III studies conducted in Japan to gather data on efficacy and safety.
Actemra(R) was launched in June 2005 in Japan as a therapy for Castleman's disease**, following approval in April, and is now in preparation for filing the additional indication of rheumatoid arthritis. Outside of Japan, phase III clinical trials in rheumatoid arthritis are going on in 41 countries worldwide including co-development between Chugai and Roche, and Roche is planning to file the application in Europe and in the US in 2007.
* Estimated by using the incidence and prevalence rate derived from a field survey on "Medical Care of Juvenile Idiopathic Arthritis and Improvement of Quality of Life, 2001," combining with the population statistics of 2003 (Ministry of Health, Labour and Welfare).
** The approved indication is "improvement of various symptoms (e.g. general malaise) and laboratory findings (e.g. increased C-reactive protein, fibrinogen, and erythrocyte sedimentation rate, decreased haemoglobin and albumin) associated with Castleman's disease."
chugai-pharm.co.jp
пятница, 22 июля 2011 г.
People With Rheumatoid Arthritis And Lupus Often Skip Their Medications
People with rheumatic diseases don't take their medication on a regular basis, and this leads to poor outcomes in their disease treatment, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.
Treatment adherence (consistently and correctly following the treatment plan outlined by a health care professional) is a crucial part of successfully managing rheumatic diseases such as rheumatoid arthritis and lupus. Although there are multiple ways health care professionals can monitor if their patients are taking medications as prescribed, electronic monitoring is considered one of the most accurate.
Recently researchers conducted two studies to look at adherence rates among people with RA and lupus to determine how well they follow their prescribed treatment plans. Throughout the course of the studies, researchers followed 110 participants with RA and 74 patients with lupus. The participants with RA were predominately Hispanic (67 percent) females (86 percent) with an average age of 49 years and who had suffered from RA for roughly seven years. The participants with lupus were predominately Black (49 percent) females (89 percent) with an average age of 36 years and who had suffered from lupus for roughly six years.
Both studies were two years long and recruited participants from two publicly-funded hospitals. With the permission of the participants, researchers monitored adherence using MEMS® caps, which are medicine bottle caps with a microchip that records the time and date of bottle openings. Each time a participant refilled a prescription, the researchers downloaded MEMS cap information. They calculated adherence to daily medications (such as disease modifying anti-rheumatic drugs and steroids) by determining the percentage of days with the correct dosage taken, and they calculated the adherence to weekly methotrexate by determining the percentage of doses taken within a week's time. Finally, researchers used MEMS cap data to estimate the percentage of prescribed doses taken by each participant.
"MEMS caps are the closest approach to a 'gold standard' to measure adherence, other than direct observation of the patients taking their medications which in this context and with our study duration is not feasible, and which is also thought to bias patients by increasing compliance when observed directly," explains Christian A. Waimann, MD and Maria F. Marengo, MD who are both at MD Anderson Cancer Center in Houston and who are the lead authors in the studies. Drs. Waimann and Marengo go on to explain that the MEMS caps system assumes that each opening of the bottle truly indicates the taking of the pill in the correct dose as prescribed by the physician.
The researchers noted the types of medications each participant was taking and evaluated each participant for physical pain and inflammation as well as social support and mental health at intervals of three, six, 12, 18 and 24 months.
Ninety-one percent of the participants with RA, and 81 percent of the participants with lupus completed the full course of their study. For those who didn't complete their study, researchers used what data they had to draw their conclusions.
Overall, the adherence rates in both study groups were low. The adherence rate for doses taken on schedule each day and/or week was 59 percent for participants in the RA study taking DMARDS and 64 percent for participants in the lupus study taking prednisone. Overall, only 61 percent of the participants in the RA study correctly took their medications, and the number ranged from 46 to 62 percent in the lupus study.
Additionally, researchers found that only one in five participants in both studies had an average adherence rate of 80 percent or higher. Although a small group, these participants reported better disease activity.
In the RA study, more participants were successful at taking the correct dosage of their medications than were successful at taking their medications on time each day and week (this was especially true with methotrexate). Participants in this study who had worse overall health and better mental health were found to be more adherent to their treatment plans. Finally, researchers noted that participants who lived alone, and those who were separated or were widowed showed less adherence, and those with social support might actually show more adherence.
In the lupus study, depression was associated with lower adherence, and better mental health increased the likelihood that participants would follow treatment plans. Also, researchers noted lower levels of disease activity among those participants who adhered to the correct dosages of their medication.
These results led researchers to conclude that there is poor treatment adherence among people with RA and lupus, at least in the populations studied, and that this lower adherence can affect those people's health in negative ways.
"It is important to ascertain if patients are taking their prescribed therapy as indicated before determining that a treatment is ineffective," explains Drs. Waimann and Marengo. "Physicians need to understand why patients may not take their medications as prescribed, and explain to patients the importance of taking medications as prescribed in order to reach treatment goals."
Source: American College of Rheumatology (ACR)
Treatment adherence (consistently and correctly following the treatment plan outlined by a health care professional) is a crucial part of successfully managing rheumatic diseases such as rheumatoid arthritis and lupus. Although there are multiple ways health care professionals can monitor if their patients are taking medications as prescribed, electronic monitoring is considered one of the most accurate.
Recently researchers conducted two studies to look at adherence rates among people with RA and lupus to determine how well they follow their prescribed treatment plans. Throughout the course of the studies, researchers followed 110 participants with RA and 74 patients with lupus. The participants with RA were predominately Hispanic (67 percent) females (86 percent) with an average age of 49 years and who had suffered from RA for roughly seven years. The participants with lupus were predominately Black (49 percent) females (89 percent) with an average age of 36 years and who had suffered from lupus for roughly six years.
Both studies were two years long and recruited participants from two publicly-funded hospitals. With the permission of the participants, researchers monitored adherence using MEMS® caps, which are medicine bottle caps with a microchip that records the time and date of bottle openings. Each time a participant refilled a prescription, the researchers downloaded MEMS cap information. They calculated adherence to daily medications (such as disease modifying anti-rheumatic drugs and steroids) by determining the percentage of days with the correct dosage taken, and they calculated the adherence to weekly methotrexate by determining the percentage of doses taken within a week's time. Finally, researchers used MEMS cap data to estimate the percentage of prescribed doses taken by each participant.
"MEMS caps are the closest approach to a 'gold standard' to measure adherence, other than direct observation of the patients taking their medications which in this context and with our study duration is not feasible, and which is also thought to bias patients by increasing compliance when observed directly," explains Christian A. Waimann, MD and Maria F. Marengo, MD who are both at MD Anderson Cancer Center in Houston and who are the lead authors in the studies. Drs. Waimann and Marengo go on to explain that the MEMS caps system assumes that each opening of the bottle truly indicates the taking of the pill in the correct dose as prescribed by the physician.
The researchers noted the types of medications each participant was taking and evaluated each participant for physical pain and inflammation as well as social support and mental health at intervals of three, six, 12, 18 and 24 months.
Ninety-one percent of the participants with RA, and 81 percent of the participants with lupus completed the full course of their study. For those who didn't complete their study, researchers used what data they had to draw their conclusions.
Overall, the adherence rates in both study groups were low. The adherence rate for doses taken on schedule each day and/or week was 59 percent for participants in the RA study taking DMARDS and 64 percent for participants in the lupus study taking prednisone. Overall, only 61 percent of the participants in the RA study correctly took their medications, and the number ranged from 46 to 62 percent in the lupus study.
Additionally, researchers found that only one in five participants in both studies had an average adherence rate of 80 percent or higher. Although a small group, these participants reported better disease activity.
In the RA study, more participants were successful at taking the correct dosage of their medications than were successful at taking their medications on time each day and week (this was especially true with methotrexate). Participants in this study who had worse overall health and better mental health were found to be more adherent to their treatment plans. Finally, researchers noted that participants who lived alone, and those who were separated or were widowed showed less adherence, and those with social support might actually show more adherence.
In the lupus study, depression was associated with lower adherence, and better mental health increased the likelihood that participants would follow treatment plans. Also, researchers noted lower levels of disease activity among those participants who adhered to the correct dosages of their medication.
These results led researchers to conclude that there is poor treatment adherence among people with RA and lupus, at least in the populations studied, and that this lower adherence can affect those people's health in negative ways.
"It is important to ascertain if patients are taking their prescribed therapy as indicated before determining that a treatment is ineffective," explains Drs. Waimann and Marengo. "Physicians need to understand why patients may not take their medications as prescribed, and explain to patients the importance of taking medications as prescribed in order to reach treatment goals."
Source: American College of Rheumatology (ACR)
вторник, 19 июля 2011 г.
Bone Medical Developing Potentially First Rheumatoid Arthritis Drug To Treat Both IL6 And TNF, Australia
New data from the Bone Medical Ltd (ASX: BNE) rheumatoid arthritis (RA) programme shows that its lead drug candidate BN006 is capable not only of down-regulating TNF secretion, but also of inhibiting secretion of IL6.
BN006 has been developed as an inhibitor of secretion of TNF, one of the cytokines involved in the inflammatory process that perpetuates RA. It has now been found that BN006 also inhibits IL6 secretion by macrophage type cells in culture with a clear dose-response relationship. This is significant as IL6 is becoming recognised as an important target alongside TNF in for new therapeutics in treatment of RA.
Although no such products have yet arrived on the market, one therapy targeting IL6 (Roche's Actemra) is in Phase III clinical trials. Roche recently reported the generation of positive data from its latest studies.
Professor Peter Brooks, Executive Dean of the Faculty of Health Sciences at the University of Queensland and a renowned world expert in arthritis, said "IL6 is one of the agents which is instrumental in creating the vicious cycle of inflammatory events in RA and could be as important in treatment of RA in the future as TNF is at present."
Both Actemra and the current anti-TNF treatments such as Remicade, Infliximab and Eternacept, are all monoclonal antibodies which need to be injected. Bone's candidate is a small molecule which could be orally available making the treatment much more patient friendly.
Dr Roger New, Chief Scientific Officer of Bone Medical, pointed out "the current monoclonal antibody treatments all target just one single component in the inflammatory process - either TNF or IL6. To have one molecule which affects both of these cytokines together could make it a much more powerful approach to treatment."
About Bone Medical Limited
Bone Medical Limited is an international biopharmaceutical development company positioned to exploit the growing market in the treatment of bone disease particularly in osteoporosis and arthritis. Bone has a portfolio of biopharmaceutical development projects for the treatment of bone disease including,
-- Osteoporosis
- Capsitonin™ oral calcitonin
- CaPTHymone™ oral parathyroid hormone
- bone cell regulators BN005 & BN008
-- Arthritis
- TNF regulators BN006
- joint protection & collagen tolerance BN007
Bone Medical Ltd
View drug information on Actemra; Remicade.
BN006 has been developed as an inhibitor of secretion of TNF, one of the cytokines involved in the inflammatory process that perpetuates RA. It has now been found that BN006 also inhibits IL6 secretion by macrophage type cells in culture with a clear dose-response relationship. This is significant as IL6 is becoming recognised as an important target alongside TNF in for new therapeutics in treatment of RA.
Although no such products have yet arrived on the market, one therapy targeting IL6 (Roche's Actemra) is in Phase III clinical trials. Roche recently reported the generation of positive data from its latest studies.
Professor Peter Brooks, Executive Dean of the Faculty of Health Sciences at the University of Queensland and a renowned world expert in arthritis, said "IL6 is one of the agents which is instrumental in creating the vicious cycle of inflammatory events in RA and could be as important in treatment of RA in the future as TNF is at present."
Both Actemra and the current anti-TNF treatments such as Remicade, Infliximab and Eternacept, are all monoclonal antibodies which need to be injected. Bone's candidate is a small molecule which could be orally available making the treatment much more patient friendly.
Dr Roger New, Chief Scientific Officer of Bone Medical, pointed out "the current monoclonal antibody treatments all target just one single component in the inflammatory process - either TNF or IL6. To have one molecule which affects both of these cytokines together could make it a much more powerful approach to treatment."
About Bone Medical Limited
Bone Medical Limited is an international biopharmaceutical development company positioned to exploit the growing market in the treatment of bone disease particularly in osteoporosis and arthritis. Bone has a portfolio of biopharmaceutical development projects for the treatment of bone disease including,
-- Osteoporosis
- Capsitonin™ oral calcitonin
- CaPTHymone™ oral parathyroid hormone
- bone cell regulators BN005 & BN008
-- Arthritis
- TNF regulators BN006
- joint protection & collagen tolerance BN007
Bone Medical Ltd
View drug information on Actemra; Remicade.
суббота, 16 июля 2011 г.
Chronic Hepatitis C Infection In A Patient With Bone Marrow Hypoplasia
HCV is acquired by intravenous drug abuse, sexually or via blood transfusion (rare nowadays due to the effective screening of blood products before transfusion). HCV is known to cause chronic infection in 80% - 90% of the patients becoming infected. Patients present with varying degrees of altered liver function ranging from mild cirrhosis to necrosis (liver cell death). Several factors namely male gender, older age at infection, excessive alcohol consumption and secondary hemochromatosis (excessive accumulation of iron in liver cells secondary to blood transfusion) enhance the fibrotic process. Furthermore, progression to cirrhosis is more rapid in patients with compromised immunity, hepatic steatosis, obesity and diabetes. Interestingly, viral factors such as viral load and genotype (6 types for HCV) do not influence the fibrosis progression Presently, evidence is accumulating on the role of HCV in association with other diseases, such as cryoglobulinemia, rheumatoid arthritis, thyroiditis to mention a few.
An article published in the World Journal of Gastroenterology addresses this report. The research team led by Prof. Kavitha Chandrikakumari from Centre Hospitalier Universitaire de Liege presentd a case of chronic HCV infection which was acquired by blood transfusion during childhood for the patient's anaemia secondary to bone marrow hypoplasia. However, the despite long duration of illness and having high serum ferritin (biological marker of iron content in the body) and cryoglobulins in her blood, the liver function remained normal through out the follow up. Patient had arthralgias and paraesthesia. Nonetheless arthritis or neuropathy was not demonstrated objectively. The patient had a normal staging on fibrotest and fibroscan (painless and non-invasive alternative to liver biopsy for assessing liver fibrosis). Chronic HCV induced translocation of immunoglobulin genes between chromosomes 14 and 18 was also negative in the patient. This translocation is known to induce B-lymphocyte proliferation and which then may progress to lymphoma (malignancy of lymphoid cells).
Reports from earlier studies in children under immunosuppression (induced by chemotherapeutic agents for the treatment of leukaemia) acquiring HCV through blood transfusion stated that these patients might not develop an immune response that could cause chronic injury. Although, this postulate was abandoned due to several conflicting reports, it is supportd in view of the normal liver function and absent fibrosis in the patient with bone marrow hypoplasia.
Chronic HCV infection might present with serious extra-hepatic manifestation rather than as hepatic disease itself. Patients immunological status might influence the extend of liver injury. HCV could be responsible for the rheumatology problems like arthritis, fibromyalgia and vasculitis.
Reference: Bethlen S, Chandrikakumari K, de Leval L, Giot JB, Mukeba D, Leonard P, Frippiat F, Meuris C, Delwaide J, Moutschen M. Chronic hepatitis C infection in a patient with bone marrow hypoplasia. World J Gastroenterol 2008; 14(26): 4238-4240
wjgnet/1007-9327/14/4238.asp
Correspondence to: Kavitha Chandrikakumari, Dr, Department of Infectious Diseases and Internal Medicine, Centre Hospitalier Universitaire de Liege, Service des Maladies Infectieuses et Medecine Interne, C.H.U, B35, Domaine du Sart-Tilman 4000, Belgium.
About World Journal of Gastroenterology
World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection. It provides a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2003-2000 IF: 3.318, 2.532, 1.445 and 0.993. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th of every month. The WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the title China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.
About The WJG Press
The WJG Press mainly publishes World Journal of Gastroenterology.
Source: Lai-Fu Li
World Journal of Gastroenterology
An article published in the World Journal of Gastroenterology addresses this report. The research team led by Prof. Kavitha Chandrikakumari from Centre Hospitalier Universitaire de Liege presentd a case of chronic HCV infection which was acquired by blood transfusion during childhood for the patient's anaemia secondary to bone marrow hypoplasia. However, the despite long duration of illness and having high serum ferritin (biological marker of iron content in the body) and cryoglobulins in her blood, the liver function remained normal through out the follow up. Patient had arthralgias and paraesthesia. Nonetheless arthritis or neuropathy was not demonstrated objectively. The patient had a normal staging on fibrotest and fibroscan (painless and non-invasive alternative to liver biopsy for assessing liver fibrosis). Chronic HCV induced translocation of immunoglobulin genes between chromosomes 14 and 18 was also negative in the patient. This translocation is known to induce B-lymphocyte proliferation and which then may progress to lymphoma (malignancy of lymphoid cells).
Reports from earlier studies in children under immunosuppression (induced by chemotherapeutic agents for the treatment of leukaemia) acquiring HCV through blood transfusion stated that these patients might not develop an immune response that could cause chronic injury. Although, this postulate was abandoned due to several conflicting reports, it is supportd in view of the normal liver function and absent fibrosis in the patient with bone marrow hypoplasia.
Chronic HCV infection might present with serious extra-hepatic manifestation rather than as hepatic disease itself. Patients immunological status might influence the extend of liver injury. HCV could be responsible for the rheumatology problems like arthritis, fibromyalgia and vasculitis.
Reference: Bethlen S, Chandrikakumari K, de Leval L, Giot JB, Mukeba D, Leonard P, Frippiat F, Meuris C, Delwaide J, Moutschen M. Chronic hepatitis C infection in a patient with bone marrow hypoplasia. World J Gastroenterol 2008; 14(26): 4238-4240
wjgnet/1007-9327/14/4238.asp
Correspondence to: Kavitha Chandrikakumari, Dr, Department of Infectious Diseases and Internal Medicine, Centre Hospitalier Universitaire de Liege, Service des Maladies Infectieuses et Medecine Interne, C.H.U, B35, Domaine du Sart-Tilman 4000, Belgium.
About World Journal of Gastroenterology
World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection. It provides a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2003-2000 IF: 3.318, 2.532, 1.445 and 0.993. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th of every month. The WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the title China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.
About The WJG Press
The WJG Press mainly publishes World Journal of Gastroenterology.
Source: Lai-Fu Li
World Journal of Gastroenterology
среда, 13 июля 2011 г.
Merck Responds To Journal Of The American Medical Association Articles
Merck & Co., Inc. today said it is committed to
high standards of scientific integrity and ethics, and believes that many of the comments in a
Journal of the American Medical Association (JAMA) news release and in the April 16 issue of
JAMA1 related to VIOXX are false, misleading or lack context. The Company said it was not
given an opportunity to respond prior to publication. The articles are based on analyses of
documents conducted by consultants hired by trial lawyers as part of their work in the VIOXX
product liability litigation, and make allegations similar to those previously advanced by these
consultants and related attorneys at trial.
"We are disappointed that such false and misleading statements about Merck from trial
lawyers have made their way into a medical journal," said Dr. Peter S. Kim, president of Merck
Research Laboratories. The Company said a full, unbiased evaluation of the Merck documents
shows significant errors in the conclusions put forward by the authors of the JAMA articles.
Merck said it believes that scientific discussion and debate can only be achieved when
accurate, factual information is presented, and that is the foundation for its interactions with
regulatory agencies and the scientific community. "The allegation that Merck misrepresented
mortality data from our Alzheimer's studies is just plain wrong," said Dr. Kim. In fact, the
Company said it provided complete mortality data from the Alzheimer's studies to the U.S. Food
and Drug Administration, as well as the mortality data from its other studies.
Responding to the assertions about scientific authorship in the JAMA articles Dr. Kim
said, "We have explicit policies governing the authorship of papers related to Merck's medicines
and vaccines, and we take those policies very seriously. The outside authors of the papers
about Merck's clinical trials referenced in the JAMA article were intimately involved in the
studies."
The Company said its policies have evolved and become more specific over time, as
have the policies of others in the health care field, including those of medical journals. Merck's
publication policies are available on merck.
"Merck remains committed to bringing forward medicines and vaccines that save and
improve people's lives," said Dr. Kim. "And we look forward to continuing to engage in
constructive, transparent discussions with the broader scientific and medical community about
our innovations."
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the
Private Securities Litigation Reform Act of 1995. These statements are based on
management's current expectations and involve risks and uncertainties, which may cause
results to differ materially from those set forth in the statements. The forward-looking
statements may include statements regarding product development, product potential or
financial performance. No forward-looking statement can be guaranteed and actual results may
differ materially from those projected. Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information, future events, or otherwise.
Forward-looking statements in this press release should be evaluated together with the many
uncertainties that affect Merck's business, particularly those mentioned in the risk factors and
cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and
in any risk factors or cautionary statements contained in the Company's periodic reports on
Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
1 Catherine D. DeAngelis; Phil B. Fontanarosa. Editorial: Impugning the Integrity of Medical
Science: The Adverse Effects of Industry Influence. JAMA. 2008;299(15):1833-1835.
Bruce M. Psaty; Richard A. Kronmal. Reporting Mortality Findings in Trials of Rofecoxib for
Alzheimer Disease or Cognitive Impairment: A Case Study Based on Documents From
Rofecoxib Litigation JAMA. 2008;299(15):1813-1817.
Joseph S. Ross; Kevin P. Hill; David S. Egilman; Harlan M. Krumholz. Guest Authorship and
Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From
Rofecoxib Litigation. JAMA. 2008;299(15):1800-1812.
View drug information on Vioxx.
high standards of scientific integrity and ethics, and believes that many of the comments in a
Journal of the American Medical Association (JAMA) news release and in the April 16 issue of
JAMA1 related to VIOXX are false, misleading or lack context. The Company said it was not
given an opportunity to respond prior to publication. The articles are based on analyses of
documents conducted by consultants hired by trial lawyers as part of their work in the VIOXX
product liability litigation, and make allegations similar to those previously advanced by these
consultants and related attorneys at trial.
"We are disappointed that such false and misleading statements about Merck from trial
lawyers have made their way into a medical journal," said Dr. Peter S. Kim, president of Merck
Research Laboratories. The Company said a full, unbiased evaluation of the Merck documents
shows significant errors in the conclusions put forward by the authors of the JAMA articles.
Merck said it believes that scientific discussion and debate can only be achieved when
accurate, factual information is presented, and that is the foundation for its interactions with
regulatory agencies and the scientific community. "The allegation that Merck misrepresented
mortality data from our Alzheimer's studies is just plain wrong," said Dr. Kim. In fact, the
Company said it provided complete mortality data from the Alzheimer's studies to the U.S. Food
and Drug Administration, as well as the mortality data from its other studies.
Responding to the assertions about scientific authorship in the JAMA articles Dr. Kim
said, "We have explicit policies governing the authorship of papers related to Merck's medicines
and vaccines, and we take those policies very seriously. The outside authors of the papers
about Merck's clinical trials referenced in the JAMA article were intimately involved in the
studies."
The Company said its policies have evolved and become more specific over time, as
have the policies of others in the health care field, including those of medical journals. Merck's
publication policies are available on merck.
"Merck remains committed to bringing forward medicines and vaccines that save and
improve people's lives," said Dr. Kim. "And we look forward to continuing to engage in
constructive, transparent discussions with the broader scientific and medical community about
our innovations."
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the
Private Securities Litigation Reform Act of 1995. These statements are based on
management's current expectations and involve risks and uncertainties, which may cause
results to differ materially from those set forth in the statements. The forward-looking
statements may include statements regarding product development, product potential or
financial performance. No forward-looking statement can be guaranteed and actual results may
differ materially from those projected. Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information, future events, or otherwise.
Forward-looking statements in this press release should be evaluated together with the many
uncertainties that affect Merck's business, particularly those mentioned in the risk factors and
cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and
in any risk factors or cautionary statements contained in the Company's periodic reports on
Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
1 Catherine D. DeAngelis; Phil B. Fontanarosa. Editorial: Impugning the Integrity of Medical
Science: The Adverse Effects of Industry Influence. JAMA. 2008;299(15):1833-1835.
Bruce M. Psaty; Richard A. Kronmal. Reporting Mortality Findings in Trials of Rofecoxib for
Alzheimer Disease or Cognitive Impairment: A Case Study Based on Documents From
Rofecoxib Litigation JAMA. 2008;299(15):1813-1817.
Joseph S. Ross; Kevin P. Hill; David S. Egilman; Harlan M. Krumholz. Guest Authorship and
Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From
Rofecoxib Litigation. JAMA. 2008;299(15):1800-1812.
View drug information on Vioxx.
воскресенье, 10 июля 2011 г.
Interleukin Genetics And The University Of North Carolina At Chapel Hill Announce Presentation Of Additional Clinical Study Findings On Osteoarthritis
Interleukin Genetics, Inc. (Pink Sheets: ILIU) and the Thurston Arthritis Research Center at the University of North Carolina at Chapel Hill announced additional findings from their previously reported 1,154-patient longitudinal study to evaluate the role of genetic factors in osteoarthritis (OA) progression. The new data, which will be presented for the first time at the American College of Rheumatology Annual Scientific Meeting in Atlanta, GA, indicates patients with radiographic signs of early knee osteoarthritis were genetically different from those without radiographic signs of the disease and progressed to moderate or severe OA at a much greater frequency.
In current clinical settings, patients with early radiographic signs of knee osteoarthritis as often determined by the Kellgren-Lawrence grading scale (grades 0 - 4, with 0 being normal and 4 severe OA) are typically considered non-diseased. As a result, patients with early-stage osteoarthritis may not receive adequate medical management to avoid pain and disability associated with disease progression. These new findings could enable at-risk patients to receive critical early intervention to offset complications associated with moderate and severe disease..
"Patients with early osteoarthritis are frequently classified as 'healthy controls' in disease-related clinical research studies. This new information should allow more explicit identification of truly healthy subjects and should also allow identification of early disease patients who may benefit from new drugs in development to modify the progression of OA," said Dr. Ken Kornman, PhD, Chief Scientific Officer, Interleukin Genetics, Inc..
The findings are the result of an analysis of 1,154 study participants in the Johnston County Osteoarthritis [JoCO OA] Project, led by Dr. Joanne Jordan, the Herman & Louise Smith Distinguished Professor of Medicine and Chief, Division of Rheumatology, Allergy, and Immunology at the Thurston Arthritis Research Center of the University of North Carolina at Chapel Hill. Participants were examined for OA and monitored for a period between 4 and 11 years to study changes in disease characteristics. Subjects at the start of the study were analyzed for genetic markers..
"This is the first study to suggest that people with possible early knee OA on their x-rays, are genetically distinct from those with no x-ray signs of knee OA. This reinforces the idea that these people actually have early OA and should be targeted for early intervention," said Dr. Jordan..
Of those individuals who were completely free of radiographic signs of knee osteoarthritis at the onset of the study, only 8.5 percent progressed to moderate or severe disease, whereas 33 percent of those with very early radiographic signs of disease exhibited progression. Those with early signs of OA were more likely than those who had no signs of disease to carry certain genetic factors, including variations in both the IL-1 receptor antagonist gene (IL1RA) and the DVWA gene that is involved in collagen formation. Both genes have been previously associated with susceptibility to knee OA and progression to severe disease. The combination of early radiographic signs of disease and carriage of gene variations associated with OA progression appears to identify individuals at increased risk for severe OA..
About the Study
The JoCO study is the first-of-its-kind to include both African-Americans and Caucasians, as well as inclusion of genetic, radiographic, serologic, physical and functional examinations of its participants. Subjects were analyzed for genetic markers that predicted those subjects who remained stable and those subjects who progressed to severe osteoarthritis, as measured radiographically. Nine genes were found to be associated with osteoarthritis progression, with the strongest prediction of progression from combinations of gene variations in the gene for IL-1Ra..
Interleukin Genetics identified and holds patents on genetic patterns that lead to over-production of interleukin-1 (IL-1), one of the key chemicals involved in cartilage and bone destruction, and on specific genetic patterns in the naturally occurring inhibitors that are predictive of IL-1 and of OA progression. The study demonstrated that three specific genetic patterns commonly found in the osteoarthritis population are strongly predictive of different risks for progression of osteoarthritis once it has been diagnosed.
Interleukin Genetics previously reported variations in the gene for IL-1Ra are strongly associated with severe knee osteoarthritis and progression..
Although OA is the greatest cause of physical disability in the U.S., there are currently no drugs approved that modify the disease progression. One of the challenges to development of new drugs in OA has been the lack of tools that predict which OA patients are more likely to progress to severe disease, thereby making clinical trials more complicated and expensive.
Certain statements contained herein are "forward-looking" statements, including statements regarding the potential for information from the study to allow more explicit identification of truly healthy subjects and identification of early disease patients. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those risks and uncertainties described in the Company's annual report on Form 10-K for the year ended December 31, 2009, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. The Company disclaims any obligation or intention to update these forward-looking statements.
Source: Interleukin Genetics, Inc
In current clinical settings, patients with early radiographic signs of knee osteoarthritis as often determined by the Kellgren-Lawrence grading scale (grades 0 - 4, with 0 being normal and 4 severe OA) are typically considered non-diseased. As a result, patients with early-stage osteoarthritis may not receive adequate medical management to avoid pain and disability associated with disease progression. These new findings could enable at-risk patients to receive critical early intervention to offset complications associated with moderate and severe disease..
"Patients with early osteoarthritis are frequently classified as 'healthy controls' in disease-related clinical research studies. This new information should allow more explicit identification of truly healthy subjects and should also allow identification of early disease patients who may benefit from new drugs in development to modify the progression of OA," said Dr. Ken Kornman, PhD, Chief Scientific Officer, Interleukin Genetics, Inc..
The findings are the result of an analysis of 1,154 study participants in the Johnston County Osteoarthritis [JoCO OA] Project, led by Dr. Joanne Jordan, the Herman & Louise Smith Distinguished Professor of Medicine and Chief, Division of Rheumatology, Allergy, and Immunology at the Thurston Arthritis Research Center of the University of North Carolina at Chapel Hill. Participants were examined for OA and monitored for a period between 4 and 11 years to study changes in disease characteristics. Subjects at the start of the study were analyzed for genetic markers..
"This is the first study to suggest that people with possible early knee OA on their x-rays, are genetically distinct from those with no x-ray signs of knee OA. This reinforces the idea that these people actually have early OA and should be targeted for early intervention," said Dr. Jordan..
Of those individuals who were completely free of radiographic signs of knee osteoarthritis at the onset of the study, only 8.5 percent progressed to moderate or severe disease, whereas 33 percent of those with very early radiographic signs of disease exhibited progression. Those with early signs of OA were more likely than those who had no signs of disease to carry certain genetic factors, including variations in both the IL-1 receptor antagonist gene (IL1RA) and the DVWA gene that is involved in collagen formation. Both genes have been previously associated with susceptibility to knee OA and progression to severe disease. The combination of early radiographic signs of disease and carriage of gene variations associated with OA progression appears to identify individuals at increased risk for severe OA..
About the Study
The JoCO study is the first-of-its-kind to include both African-Americans and Caucasians, as well as inclusion of genetic, radiographic, serologic, physical and functional examinations of its participants. Subjects were analyzed for genetic markers that predicted those subjects who remained stable and those subjects who progressed to severe osteoarthritis, as measured radiographically. Nine genes were found to be associated with osteoarthritis progression, with the strongest prediction of progression from combinations of gene variations in the gene for IL-1Ra..
Interleukin Genetics identified and holds patents on genetic patterns that lead to over-production of interleukin-1 (IL-1), one of the key chemicals involved in cartilage and bone destruction, and on specific genetic patterns in the naturally occurring inhibitors that are predictive of IL-1 and of OA progression. The study demonstrated that three specific genetic patterns commonly found in the osteoarthritis population are strongly predictive of different risks for progression of osteoarthritis once it has been diagnosed.
Interleukin Genetics previously reported variations in the gene for IL-1Ra are strongly associated with severe knee osteoarthritis and progression..
Although OA is the greatest cause of physical disability in the U.S., there are currently no drugs approved that modify the disease progression. One of the challenges to development of new drugs in OA has been the lack of tools that predict which OA patients are more likely to progress to severe disease, thereby making clinical trials more complicated and expensive.
Certain statements contained herein are "forward-looking" statements, including statements regarding the potential for information from the study to allow more explicit identification of truly healthy subjects and identification of early disease patients. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those risks and uncertainties described in the Company's annual report on Form 10-K for the year ended December 31, 2009, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. The Company disclaims any obligation or intention to update these forward-looking statements.
Source: Interleukin Genetics, Inc
четверг, 7 июля 2011 г.
What Is a Ganglion? What Is a Ganglion Cyst?
Ganglion cysts are fluid-filled swellings that tend to form on top of joints or tendons in the wrists, hands, and feet. They have the appearance of firm or spongy sacs of liquid and their insides consist of a sticky, clear, thick, jelly-like fluid. Ganglion cysts are idiopathic, which means they generally form for unknown reasons. As painless and benign (not dangerous) growths, ganglion cysts often do not require treatment and go away on their own.
According to Medilexicon's medical dictionary, a ganglion cyst is "A cyst containing mucopolysaccharide-rich fluid within fibrous tissue or, occasionally, muscle bone or a semilunar cartilage; usually attached to a tendon sheath in the hand, wrist, or foot, or connected with the underlying joint."
News on Bones / Orthopedics
For the latest news and research on Bones / Orthopedics, and to sign up to newsletters or news alerts, please visit our Bones / Orthopedics News Section.
A ganglion is also a collection of nerve cell bodies located outside the central nervous system. This article refers only to fluid-like swellings that form on top of joints, tendons in the wrists, hands and feet (ganglion cysts).
Who gets ganglion cysts?
Women are more likely than men to develop ganglion cysts. The risk of ganglion cysts is also greater for those who stress the wrist and hand with regular repetitive movement, who have osteoarthritis, and who have injured joints or tendons in the hands or feet.
What causes ganglion cysts?
The exact causes of ganglion cysts remain unknown. However, some researchers and physicians believe that small cysts can form when trauma damages the tissue of a joint. A well-supported theory posits that ganglion cysts form because of a flaw in the joint capsule or tendon sheath that permits the joint tissue to protrude outwards.
What are the symptoms of a ganglion cyst?
A ganglion cyst usually appears as a stationary, smooth bump from 1 to 3 centimeters in diameter. The cyst may disappear and reappear, may be soft or firm, and it may change size. Sometimes, a ganglion cyst will cause pain, aching, or numbness if it presses upon nerves. When attached to a tendon, the cyst can make the affected area feel weaker.
How are ganglion cysts diagnosed?
A physical examination is generally sufficient for diagnosing a ganglion cyst. A doctor may also order imaging tests such as an X-ray, ultrasound, or magnetic resonance imaging (MRI) in order to learn more about the characteristics of the cyst and to rule out conditions such as arthritis and malignant tumors. Confirmation of a ganglion cyst also may be aided by aspiration - when a doctor uses a syringe to gather fluid from inside the cyst.
How are ganglion cysts treated?
Ganglion cysts often do not require treatments, as they will rupture and disappear on their own. However, it is possible to use a syringe to remove the fluid (aspiration) or resect the entire ganglion in a surgical procedure. Aspiration also may involve injection of a steroid for anti-inflammatory purposes and a splinting of the cyst area to prevent it from moving. There is no guarantee that ganglion cysts will not reappear after any type of procedure.
How can ganglion cysts be prevented?
Because the causes of ganglion cysts are not well-understood, there are not suggested preventive measures.
Written by Peter Crosta M.A.
According to Medilexicon's medical dictionary, a ganglion cyst is "A cyst containing mucopolysaccharide-rich fluid within fibrous tissue or, occasionally, muscle bone or a semilunar cartilage; usually attached to a tendon sheath in the hand, wrist, or foot, or connected with the underlying joint."
News on Bones / Orthopedics
For the latest news and research on Bones / Orthopedics, and to sign up to newsletters or news alerts, please visit our Bones / Orthopedics News Section.
A ganglion is also a collection of nerve cell bodies located outside the central nervous system. This article refers only to fluid-like swellings that form on top of joints, tendons in the wrists, hands and feet (ganglion cysts).
Who gets ganglion cysts?
Women are more likely than men to develop ganglion cysts. The risk of ganglion cysts is also greater for those who stress the wrist and hand with regular repetitive movement, who have osteoarthritis, and who have injured joints or tendons in the hands or feet.
What causes ganglion cysts?
The exact causes of ganglion cysts remain unknown. However, some researchers and physicians believe that small cysts can form when trauma damages the tissue of a joint. A well-supported theory posits that ganglion cysts form because of a flaw in the joint capsule or tendon sheath that permits the joint tissue to protrude outwards.
What are the symptoms of a ganglion cyst?
A ganglion cyst usually appears as a stationary, smooth bump from 1 to 3 centimeters in diameter. The cyst may disappear and reappear, may be soft or firm, and it may change size. Sometimes, a ganglion cyst will cause pain, aching, or numbness if it presses upon nerves. When attached to a tendon, the cyst can make the affected area feel weaker.
How are ganglion cysts diagnosed?
A physical examination is generally sufficient for diagnosing a ganglion cyst. A doctor may also order imaging tests such as an X-ray, ultrasound, or magnetic resonance imaging (MRI) in order to learn more about the characteristics of the cyst and to rule out conditions such as arthritis and malignant tumors. Confirmation of a ganglion cyst also may be aided by aspiration - when a doctor uses a syringe to gather fluid from inside the cyst.
How are ganglion cysts treated?
Ganglion cysts often do not require treatments, as they will rupture and disappear on their own. However, it is possible to use a syringe to remove the fluid (aspiration) or resect the entire ganglion in a surgical procedure. Aspiration also may involve injection of a steroid for anti-inflammatory purposes and a splinting of the cyst area to prevent it from moving. There is no guarantee that ganglion cysts will not reappear after any type of procedure.
How can ganglion cysts be prevented?
Because the causes of ganglion cysts are not well-understood, there are not suggested preventive measures.
Written by Peter Crosta M.A.
понедельник, 4 июля 2011 г.
What Is Osteoarthritis? What Causes Osteoarthritis?
Osteoarthritis, also known as degenerative arthritis degenerative joint disease, OA, or osteoarthrosis, is a form of arthritis caused by inflammation, breakdown, and the eventual loss of cartilage in the joints - the cartilage wears down over time.
Osteoarthritis is the most common type of arthritis. According to the National Health Service, UK, approximately 8.5 million people are affected by the condition. The Arthritis Foundation, USA, says that about 27 million Americans are affected.
Osteoarthritis is a progressive disease; signs and symptoms gradually worsen over time. There is no cure. However, available therapies may help with pain and swelling (inflammation), as well as keeping the patient mobile and active. Experts say that patients who take steps to actively manage their osteoarthritis are more likely to gain control over their symptoms.
Any joint in the body may be affected. However, the disease is most likely to affects the patient's:
Hands
Hips
Knees
Lower back
Neck
Osteoarthritis has three characteristics:
Bony growths develop around the edge of joints.
It damages cartilage - Cartilage is the part of the joint that cushions the ends of the bones and allows easy movement of joints.
Synovitis - there is mild inflammation of the tissues around the joints.
Osteoarthritis is more common among females than males, especially after the age of 50 years. Most commonly, it develops in people aged over 40. Younger people may also be affected; usually after an injury or as a result of another joint condition.
Some people say that osteoarthritis is an inevitable part of ageing. This is untrue. There are people well into their nineties who have no clinical or functional signs of the disease.
According to the Arthritis Foundation, USA:
Women are more affected by osteoarthritis than men after the age of 50.
Symptoms typically start after 40 years of age, and progress slowly.
In America, loss of joint function due to osteoarthritis is a major cause of work disability and reduced quality of life.
In America, arthritis and related conditions, such as osteoarthritis cost the country almost $128 billion annually in medical care and indirect expenses, including lost income and productivity.
The average direct cost of osteoarthritis in America is about $2,800 per patient annually.
The total annual cost of osteoarthritis per person living with the condition is about $5,700.
According to Medilexicon's medical dictionary:
Osteoarthritis is " Arthritis characterized by erosion of articular cartilage, either primary or secondary to trauma or other conditions, which becomes soft, frayed, and thinned with eburnation of subchondral bone and outgrowths of marginal osteophytes; pain and loss of function result; mainly affects weight-bearing joints, is more common in old people and animals.
What are the signs and symptoms of osteoarthritis?
A symptom is something the patient feels and reports, while a sign is something other people, such as the doctor detect. For example, pain may be a symptom while a rash may be a sign.
Osteoarthritis has as its main symptoms:
Pain
Problems moving affected joints.
Stiffness - more severe on waking up in the morning, and improves within 30 minutes when the individual starts moving about.
In some cases people with osteoarthritis may have no symptoms. Symptoms are usually only felt in either one joint, or a just a few at any one time. In many cases the symptoms come on slowly.
Other signs and symptoms may include:
Affected joints are larger than usual
After not moving the joint for a while pain and stiffness may worsen
Joints are warm
Loss of muscle bulk
Tenderness in the affected joint
The affected joints will have a limited range of movements
The patient may experience a grating or crackling sound/sensation in the affected joint
The knees, hips or hands are most commonly affected.
Osteoarthritis in the knees - in most cases both knees are affected, unless the osteoarthritis was caused by an injury (or another condition). The patient will experience pain when walking, especially uphill or upstairs. Knees may lock into position, making it much harder to straighten the leg. The knee may make a soft, grating sound when used.
Osteoarthritis in the hips - anything that requires movement of the hip joint causes problems, such as getting in/out of a car, or putting on one's shoes and socks.
Although pain in the hip is common, some patients with osteoarthritis in the hips experience pain in their knee (and not their hip). Less commonly, pain may be felt in the thighs, ankles and buttocks.
Typically, pain is felt whilst walking. But some people are in pain even when resting.
Osteoarthritis in the hands - three areas may be affected:
The base of the thumb
The top joint of the fingers (closest to the nail)
The middle joint of the fingers
Fingers may be stiff, swollen and painful. Sometimes bumps may develop on the finger joints. In some cases, finger pain decreases and eventually goes away, while the swelling and bumps remain.
At the affected joints the fingers may bend slightly sideways. Fluid-filled lumps (cysts) may develop on the backs of the fingers; they are often painful.
A bump may develop where the base of the thumb joins the wrist. This may make writing, turning keys and opening jar-tops difficult and painful.
When to see a doctor
People who have joint stiffness and swelling that persist for more than a couple of weeks, they should see their doctor. Those already on osteoarthritis medications should contact a health care professional if they experience nausea, constipation, drowsiness, abdominal discomfort, or have black/tarry stools.
What are the risk factors for osteoarthritis?
A risk factor is something which increases the likelihood of developing a condition or disease. For example, obesity significantly raises the risk of developing diabetes type 2. Therefore, obesity is a risk factor for diabetes type 2.
Age - individuals under the age of 40 rarely develop osteoarthritis. It typically occurs in older adults.
Gender - females are more likely to develop osteoarthritis than males.
Deformities of the bone(s) - patients born with defective joints or cartilage have a significantly higher risk of eventually developing osteoarthritis.
Injuries - especially those resulting from an accident or some sports may raise the risk of developing osteoarthritis.
Obesity - obese people whose weight-bearing joints are under a greater strain have a higher risk of developing the condition, compared to people of normal weight.
Some jobs - especially those that involve repetitive movements that target stress on a particular joint may have a higher risk of developing osteoarthritis.
People with other diseases and conditions may have a higher risk of developing the condition. Examples include:
Gout
Rheumatoid arthritis
Paget's disease of the bone
Septic arthritis
Genetics - it is estimated that approximately 40% to 60% of cases of hand, hip and knee osteoarthritis may have a genetic link. The genes have not yet been identified. In other words, osteoarthritis, or a predisposition to developing the condition may be inherited.
What are the causes of osteoarthritis?
Process of wear and repair - often inaccurately referred to as the wear and tear arthritis, osteoarthritis should more aptly be called the wear and repair arthritis, because the condition is a slow repair process that the body utilizes to mend joints that have gradually become damaged.
In most cases, the repair process presents no symptoms. However, if there is a particularly traumatic injury to a joint and the body's ability to carry out proper repairs is undermined, subsequent damage to the affected joint will continue and the patient will experience symptoms.
When there is damage to cartilage - the protective surface that cushions the ends of bones in your joints and allows the joints to move smoothly - osteoarthritis occurs. The smooth surface of the cartilage becomes rough, causing irritation. If the cartilage wears down completely, the bone in the joint may be rubbing against another bone, causing damage and pain.
The joints may become knobbly where the bones start protruding, forming osteophytes (bony lumps). The bones gradually thicken and become broader, making the joints stiffer, less mobile, and painful. If fluid accumulates in the joints they will swell.
Experts are not sure why the repair process breaks down. They believe several contributory factors are involved:
Injury - a joint may have been previously damaged because of an injury or surgical intervention.
Overuse - a joint may have been overused after an injury or operation.
Rheumatoid arthritis - if the joints of a patient with rheumatoid arthritis have been severely damaged, osteoarthritis can occur.
When osteoarthritis has developed because of damage or another condition, it is called secondary osteoarthritis. Secondary osteoarthritis signs and symptoms may take several years after the initial joint damage to appear.
Diagnosing osteoarthritis
A GP (general practitioner, primary care physician) will ask the patient about symptoms, as well as carrying out a physical examination. There is no current and definitive test that can diagnose osteoarthritis.
The following may help the doctor suspect osteoarthritis:
There is joint stiffness first thing in the morning
The joint stiffness first thing in the morning lasts no more than 30 minutes
The pain is persistent
The pain worsens when the affected joint is used
The patient is over 40 to 45 years of age
If symptoms differ slightly from those mentioned above the doctor may suspect that the patient has another type of arthritis. Patients with rheumatoid arthritis also have early morning stiffness, but it lasts longer than an hour.
The GP will not usually order imaging or blood tests unless he/she wishes to rule out other conditions, such as another type of arthritis, or perhaps a fractured bone. Tests may include:
X-rays - images may show that the cartilage is breaking down, if a narrowing space within a joint is detected. Bone spurs around a joint may also be revealed. It is not uncommon for people with no osteoarthritis symptoms to have X-ray signs of the condition.
MRI (magnetic resonance imaging) scan - this device uses a magnetic field and radio waves to create detailed images of the inside of the body, including bone and bone cartilage. An MRI scan can help the doctor determine what is causing pain.
Blood tests - these are usually performed in order to rule out other conditions, especially rheumatoid arthritis.
Joint fluid analysis (arthrocentesis) - a sterile needle is used to withdraw (aspirate) fluid from an inflamed joint and then sent to the lab. If uric acid crystals are present it is more likely the patient has gout. This test can also determine whether there is inflammation or an infection.
What are the treatment options for osteoarthritis?
There is no cure for osteoarthritis. Treatment consists of exercise, manual therapy, lifestyle modification, medication and other interventions to alleviate pain and maintain joint movement.
Medications
Acetimophen (paracetamol, Tylenol) - although this medication does not reduce inflammation, it does relieve pain, especially among patients with mild to moderate symptoms. As high doses can cause liver damage, especially if the patient regularly consumes alcohol, it is important to stay within the recommended dosage. As acetaminophen may affect how some other medications work, it is important that the patient informs the doctor if he/she is taking it.
NSAIDs (non-steroidal anti-inflammatory drugs) - if acetimophen is not effective in controlling pain, the doctor may prescribe a stronger painkiller, which may include ibuprofen, aspirin or diclofenac.
Some topical NSAIDs can be applied directly onto the affected joints (on the skin). Some OTC (over-the-counter, no prescription required) topical NSAIDs are very effective if the osteoarthritis affects the knees or hands. Not only do they ease pain, but also help reduce swelling in the joints.
Patients with asthma or peptic ulcers may not be able to take NSAIDs. Patients should check with their doctor about NSAID suitability.
Children under the age of 16 years should not take aspirin.
If an oral NSAID is prescribed, the doctor may also prescribe a PPI (proton pump inhibitor) to be taken at the same time. NSAIDs can break down the lining of the stomach - the lining of the stomach protects against stomach acid. PPIs reduce the amount of acid by blocking the pumps (tiny ducts) in the stomach that produce it, resulting in a significantly lower risk of damage to the stomach lining. Other NSAID side effects may include tinnitus (ringing in the ears), cardiovascular problems, and liver and/or kidney damage. The risk of side effects are greater if the dose is high, or if the medication is taken long-term.
Tramadol (Ultram) - this is a prescription centrally acting analgesic which has no anti-inflammatory effect (does not reduce swelling). However, it provides effective pain relief with fewer side effects, compared to NSAIDs. Patients may experience nausea and/or constipation. Tramadol is typically used for short-term acute flare ups. Sometimes the doctor may prescribe tramadol alongside acetaminophen for more powerful pain relief.
Codeine or propoxyphene (Darvon) - these may be useful for more severe osteoarthritis symptoms. There is a risk of dependence - this risk is seen as small if the patient is in severe pain. Side effects may sometimes include constipation and drowsiness.
Capsaicin cream - patients with osteoarthritis in their hands or knees who did not respond well to topical NSAIDs may be prescribed capsaicin cream. The medication blocks the nerves that send pain messages. However, the drug's effects may not be noticeable for a while; pain relief should be noticed within a couple of weeks, but this medication's full effect may not be appreciated for up to a month.
A tiny amount of capsaicin cream should be applied to the affected joints four times daily (no more than once every four hours). Do not apply it to broken or inflamed skin.
After use it is important to wash one's hands thoroughly. Capsaicin cream is made from chillies. If any of it gets into the patients eyes, mouth, nose or genitals it is likely to cause pain (without damage).
When first applying capsaicin cream onto the skin there may be a burning sensation, this is normal. After some use that sensation goes away. Avoid having a hot bath or shower before or after applying the cream.
Intra-articular injections (cortisone shots) - in some cases pain symptoms may be so severe that analgesics (painkillers) are not enough. In such cases the medication may be injected directly into the site of the joint. Usually, these will be injections of corticosteroids. Corticosteroids are effective for pain relief and to reduce swelling. The National Institute of Health and Clinical Excellence (NICE), UK, which decides on approved treatments for the National Health Service (NHS), does not recommend intra-articular injections of hyaluronic acid for osteoarthritis.
Each joint should not be treated in this way more than three times a year. Too many intra-articular injections can damage the joint.
Treatment with a physical therapist (UK: physiotherapist)
TENS (transcutaneous electrical nerve stimulation) - this is the application of electrical current through the skin for pain control. A TENS unit is usually connected to the skin using two or more electrodes. It works by numbing the nerves endings in the spinal cord that control pain.
Thermotherapy - warm and cold temperatures are used to help reduce pain and stiffness in the joints. For example, a hot water bottle is filled with either hot or cold water and applied to the affected area. Some patients find this therapy helps with pain. Alternatively, hot and cold packs may be used - they are either cooled in the freezer or heated up in a microwave oven.
Manual therapy - this treatment is performed by a physical therapist who uses stretching techniques to keep the joints flexible and supple. If the patient is not using the affected joint the muscle may weaken, further worsening osteoarthritis stiffness.
Assistive devices - in some cases osteoarthritis may cause problems with mobility. The patient may find everyday tasks difficult to do. There several devices which may help. Most doctors refer their patient to either an occupational therapist, a physical therapist, or both.
Problems with the lower limbs - people whose hips, knees or feet are affected may benefit from wearing special footwear, or shoe-insoles. Some shock-absorbing soles can reduce the pressure on the joints. Special insoles may help distribute bodyweight more evenly. Some patients may find that leg braces help.
Holding a stick or cane on the opposite side of the body to the affected leg may help.
If the patient needs to rest a painful joint a splint may help. A splint is a piece of rigid material that provides joint or bone support.
Hand problems - special devices, such as tap-turners can make everyday tasks easier. An occupational therapist is trained to help people carry out their everyday tasks more easily at home and in the workplace.
Surgery - this may sometimes help patients with osteoarthritis that affects their hips, knees, joints, and at the base of their thumbs. However, in most cases surgery is not needed, and is only usually recommended if other therapies have been ineffective, or if one of the joints is severely damaged.
The doctor will refer the patient to an orthopedic surgeon before symptoms become too severe, or before the osteoarthritis causes to much permanent damage. Examples of surgery include:
Arthroplasty (joint replacement) - total replacement of the joint. The damaged parts are surgically removed and a prosthesis (artificial joint) made of metal and plastic is inserted. The most commonly replaced joints are the hip and knee joints. However, implants can currently replace the joints in the shoulder, finger, ankle and elbow. Arthroplasty is usually very effective, allowing the patient to use the joint actively and painlessly. Arthroplasty of the hand joints can help their appearance, as well as their function. There is a small risk of infection and bleeding. Sometimes they may come loose or wear down, and may need to be replaced (eventually).
Arthrodesis - if a joint replacement is not an option, the joint may be surgically fixed to promote a bone fusion; the joint is realigned or stabilized. Also called artificial ankylosis, syndesis. This increases stability and reduces pain. If the joint in the ankle is fused the patient will be able to bear weight on it painlessly - however, it will have no flexibility.
Osteotomy - the surgeon adds or removes a small section of bone either above or below the knee joint to realign the leg so that the patient's weight is no longer focused on the damaged part of the joint. This procedure may be used if the patient is too young for knee replacement surgery (arthroplasty). Although this procedure helps relieve symptoms significantly, there may be a need for knee replacement surgery later on.
Osteoarthritis self-help
There are several things patients can do to help ease the symptoms of osteoarthritis. A doctor or physical therapist should be able to offer useful advice on lifestyle changes. Some patients may only need the changes listed below to keep their symptoms under control:
Exercise - even though the idea of doing exercise when a patient's joints are stiff and painful may seem odd, exercise is a key part of osteoarthritis treatment. Exercise helps:
Keep the patient active and mobile
Build up muscle, resulting in stronger joints
Relieve mental and emotional stress
Help achieve body weight control
Improve posture
All the above-mentioned benefits of exercise help reduce osteoarthritis symptoms.
Patients who have a good doctor or physical therapist should be able to devise an effective and suitable exercise program, which can be done at home or at the local gym. Many gyms today are geared up to help people with arthritis. The patient needs to follow the program carefully, and make sure he/she does not do the wrong exercises or do the exercises incorrectly, which may cause damage.
An exercise plan will probably focus on improving the patient's:
Flexibility - to help with the range of movement. This will involve gently stretching the joints, making them suppler.
Strength - to improve muscle tone and strength.
Fitness - to improve stamina. This may involve swimming, walking or cycling.
Weight control - the more overweight/obese patients are, the worse their osteoarthritis symptoms will be, simply because there is much more weight bearing down on the joints, especially if the affected joints are in the lower limbs.
Losing weight, and maintaining ideal body weight involves eating properly, doing exercise, and sleeping at least 7.5 hours each day. Patients should consult with a doctor, physical therapist or nutritionist before embarking on any exercise program or special diet.
What are the possible complications of osteoarthritis?
Mobility - some patients may find it hard to move around. There is a greater risk of trips and falls, and their subsequent injuries.
Disability - it is not true that osteoarthritis eventually leads to disability. In the majority of cases the condition does cause pain and discomfort, but no permanent disability. In some cases though, it can sometimes eventually leave the patient disabled.
Work - some patients may find that osteoarthritis symptoms interfere with their ability to work properly. This can result in frustration, irritability and depression. Patients who experience psychological problems should tell their GP or occupational therapist. Talking to one's employer often helps too.
Septic arthritis - this is joint inflammation caused by bacteria infecting the joint. Patients who undergo arthroplasty (joint replacement surgery) run a small risk of infection. Septic arthritis is a medical emergency, and the patient needs to be hospitalized. Treatment involves antibiotic medication and drainage of the infected joint fluid from the joint.
Written by
Osteoarthritis is the most common type of arthritis. According to the National Health Service, UK, approximately 8.5 million people are affected by the condition. The Arthritis Foundation, USA, says that about 27 million Americans are affected.
Osteoarthritis is a progressive disease; signs and symptoms gradually worsen over time. There is no cure. However, available therapies may help with pain and swelling (inflammation), as well as keeping the patient mobile and active. Experts say that patients who take steps to actively manage their osteoarthritis are more likely to gain control over their symptoms.
Any joint in the body may be affected. However, the disease is most likely to affects the patient's:
Hands
Hips
Knees
Lower back
Neck
Osteoarthritis has three characteristics:
Bony growths develop around the edge of joints.
It damages cartilage - Cartilage is the part of the joint that cushions the ends of the bones and allows easy movement of joints.
Synovitis - there is mild inflammation of the tissues around the joints.
Osteoarthritis is more common among females than males, especially after the age of 50 years. Most commonly, it develops in people aged over 40. Younger people may also be affected; usually after an injury or as a result of another joint condition.
Some people say that osteoarthritis is an inevitable part of ageing. This is untrue. There are people well into their nineties who have no clinical or functional signs of the disease.
According to the Arthritis Foundation, USA:
Women are more affected by osteoarthritis than men after the age of 50.
Symptoms typically start after 40 years of age, and progress slowly.
In America, loss of joint function due to osteoarthritis is a major cause of work disability and reduced quality of life.
In America, arthritis and related conditions, such as osteoarthritis cost the country almost $128 billion annually in medical care and indirect expenses, including lost income and productivity.
The average direct cost of osteoarthritis in America is about $2,800 per patient annually.
The total annual cost of osteoarthritis per person living with the condition is about $5,700.
According to Medilexicon's medical dictionary:
Osteoarthritis is " Arthritis characterized by erosion of articular cartilage, either primary or secondary to trauma or other conditions, which becomes soft, frayed, and thinned with eburnation of subchondral bone and outgrowths of marginal osteophytes; pain and loss of function result; mainly affects weight-bearing joints, is more common in old people and animals.
What are the signs and symptoms of osteoarthritis?
A symptom is something the patient feels and reports, while a sign is something other people, such as the doctor detect. For example, pain may be a symptom while a rash may be a sign.
Osteoarthritis has as its main symptoms:
Pain
Problems moving affected joints.
Stiffness - more severe on waking up in the morning, and improves within 30 minutes when the individual starts moving about.
In some cases people with osteoarthritis may have no symptoms. Symptoms are usually only felt in either one joint, or a just a few at any one time. In many cases the symptoms come on slowly.
Other signs and symptoms may include:
Affected joints are larger than usual
After not moving the joint for a while pain and stiffness may worsen
Joints are warm
Loss of muscle bulk
Tenderness in the affected joint
The affected joints will have a limited range of movements
The patient may experience a grating or crackling sound/sensation in the affected joint
The knees, hips or hands are most commonly affected.
Osteoarthritis in the knees - in most cases both knees are affected, unless the osteoarthritis was caused by an injury (or another condition). The patient will experience pain when walking, especially uphill or upstairs. Knees may lock into position, making it much harder to straighten the leg. The knee may make a soft, grating sound when used.
Osteoarthritis in the hips - anything that requires movement of the hip joint causes problems, such as getting in/out of a car, or putting on one's shoes and socks.
Although pain in the hip is common, some patients with osteoarthritis in the hips experience pain in their knee (and not their hip). Less commonly, pain may be felt in the thighs, ankles and buttocks.
Typically, pain is felt whilst walking. But some people are in pain even when resting.
Osteoarthritis in the hands - three areas may be affected:
The base of the thumb
The top joint of the fingers (closest to the nail)
The middle joint of the fingers
Fingers may be stiff, swollen and painful. Sometimes bumps may develop on the finger joints. In some cases, finger pain decreases and eventually goes away, while the swelling and bumps remain.
At the affected joints the fingers may bend slightly sideways. Fluid-filled lumps (cysts) may develop on the backs of the fingers; they are often painful.
A bump may develop where the base of the thumb joins the wrist. This may make writing, turning keys and opening jar-tops difficult and painful.
When to see a doctor
People who have joint stiffness and swelling that persist for more than a couple of weeks, they should see their doctor. Those already on osteoarthritis medications should contact a health care professional if they experience nausea, constipation, drowsiness, abdominal discomfort, or have black/tarry stools.
What are the risk factors for osteoarthritis?
A risk factor is something which increases the likelihood of developing a condition or disease. For example, obesity significantly raises the risk of developing diabetes type 2. Therefore, obesity is a risk factor for diabetes type 2.
Age - individuals under the age of 40 rarely develop osteoarthritis. It typically occurs in older adults.
Gender - females are more likely to develop osteoarthritis than males.
Deformities of the bone(s) - patients born with defective joints or cartilage have a significantly higher risk of eventually developing osteoarthritis.
Injuries - especially those resulting from an accident or some sports may raise the risk of developing osteoarthritis.
Obesity - obese people whose weight-bearing joints are under a greater strain have a higher risk of developing the condition, compared to people of normal weight.
Some jobs - especially those that involve repetitive movements that target stress on a particular joint may have a higher risk of developing osteoarthritis.
People with other diseases and conditions may have a higher risk of developing the condition. Examples include:
Gout
Rheumatoid arthritis
Paget's disease of the bone
Septic arthritis
Genetics - it is estimated that approximately 40% to 60% of cases of hand, hip and knee osteoarthritis may have a genetic link. The genes have not yet been identified. In other words, osteoarthritis, or a predisposition to developing the condition may be inherited.
What are the causes of osteoarthritis?
Process of wear and repair - often inaccurately referred to as the wear and tear arthritis, osteoarthritis should more aptly be called the wear and repair arthritis, because the condition is a slow repair process that the body utilizes to mend joints that have gradually become damaged.
In most cases, the repair process presents no symptoms. However, if there is a particularly traumatic injury to a joint and the body's ability to carry out proper repairs is undermined, subsequent damage to the affected joint will continue and the patient will experience symptoms.
When there is damage to cartilage - the protective surface that cushions the ends of bones in your joints and allows the joints to move smoothly - osteoarthritis occurs. The smooth surface of the cartilage becomes rough, causing irritation. If the cartilage wears down completely, the bone in the joint may be rubbing against another bone, causing damage and pain.
The joints may become knobbly where the bones start protruding, forming osteophytes (bony lumps). The bones gradually thicken and become broader, making the joints stiffer, less mobile, and painful. If fluid accumulates in the joints they will swell.
Experts are not sure why the repair process breaks down. They believe several contributory factors are involved:
Injury - a joint may have been previously damaged because of an injury or surgical intervention.
Overuse - a joint may have been overused after an injury or operation.
Rheumatoid arthritis - if the joints of a patient with rheumatoid arthritis have been severely damaged, osteoarthritis can occur.
When osteoarthritis has developed because of damage or another condition, it is called secondary osteoarthritis. Secondary osteoarthritis signs and symptoms may take several years after the initial joint damage to appear.
Diagnosing osteoarthritis
A GP (general practitioner, primary care physician) will ask the patient about symptoms, as well as carrying out a physical examination. There is no current and definitive test that can diagnose osteoarthritis.
The following may help the doctor suspect osteoarthritis:
There is joint stiffness first thing in the morning
The joint stiffness first thing in the morning lasts no more than 30 minutes
The pain is persistent
The pain worsens when the affected joint is used
The patient is over 40 to 45 years of age
If symptoms differ slightly from those mentioned above the doctor may suspect that the patient has another type of arthritis. Patients with rheumatoid arthritis also have early morning stiffness, but it lasts longer than an hour.
The GP will not usually order imaging or blood tests unless he/she wishes to rule out other conditions, such as another type of arthritis, or perhaps a fractured bone. Tests may include:
X-rays - images may show that the cartilage is breaking down, if a narrowing space within a joint is detected. Bone spurs around a joint may also be revealed. It is not uncommon for people with no osteoarthritis symptoms to have X-ray signs of the condition.
MRI (magnetic resonance imaging) scan - this device uses a magnetic field and radio waves to create detailed images of the inside of the body, including bone and bone cartilage. An MRI scan can help the doctor determine what is causing pain.
Blood tests - these are usually performed in order to rule out other conditions, especially rheumatoid arthritis.
Joint fluid analysis (arthrocentesis) - a sterile needle is used to withdraw (aspirate) fluid from an inflamed joint and then sent to the lab. If uric acid crystals are present it is more likely the patient has gout. This test can also determine whether there is inflammation or an infection.
What are the treatment options for osteoarthritis?
There is no cure for osteoarthritis. Treatment consists of exercise, manual therapy, lifestyle modification, medication and other interventions to alleviate pain and maintain joint movement.
Medications
Acetimophen (paracetamol, Tylenol) - although this medication does not reduce inflammation, it does relieve pain, especially among patients with mild to moderate symptoms. As high doses can cause liver damage, especially if the patient regularly consumes alcohol, it is important to stay within the recommended dosage. As acetaminophen may affect how some other medications work, it is important that the patient informs the doctor if he/she is taking it.
NSAIDs (non-steroidal anti-inflammatory drugs) - if acetimophen is not effective in controlling pain, the doctor may prescribe a stronger painkiller, which may include ibuprofen, aspirin or diclofenac.
Some topical NSAIDs can be applied directly onto the affected joints (on the skin). Some OTC (over-the-counter, no prescription required) topical NSAIDs are very effective if the osteoarthritis affects the knees or hands. Not only do they ease pain, but also help reduce swelling in the joints.
Patients with asthma or peptic ulcers may not be able to take NSAIDs. Patients should check with their doctor about NSAID suitability.
Children under the age of 16 years should not take aspirin.
If an oral NSAID is prescribed, the doctor may also prescribe a PPI (proton pump inhibitor) to be taken at the same time. NSAIDs can break down the lining of the stomach - the lining of the stomach protects against stomach acid. PPIs reduce the amount of acid by blocking the pumps (tiny ducts) in the stomach that produce it, resulting in a significantly lower risk of damage to the stomach lining. Other NSAID side effects may include tinnitus (ringing in the ears), cardiovascular problems, and liver and/or kidney damage. The risk of side effects are greater if the dose is high, or if the medication is taken long-term.
Tramadol (Ultram) - this is a prescription centrally acting analgesic which has no anti-inflammatory effect (does not reduce swelling). However, it provides effective pain relief with fewer side effects, compared to NSAIDs. Patients may experience nausea and/or constipation. Tramadol is typically used for short-term acute flare ups. Sometimes the doctor may prescribe tramadol alongside acetaminophen for more powerful pain relief.
Codeine or propoxyphene (Darvon) - these may be useful for more severe osteoarthritis symptoms. There is a risk of dependence - this risk is seen as small if the patient is in severe pain. Side effects may sometimes include constipation and drowsiness.
Capsaicin cream - patients with osteoarthritis in their hands or knees who did not respond well to topical NSAIDs may be prescribed capsaicin cream. The medication blocks the nerves that send pain messages. However, the drug's effects may not be noticeable for a while; pain relief should be noticed within a couple of weeks, but this medication's full effect may not be appreciated for up to a month.
A tiny amount of capsaicin cream should be applied to the affected joints four times daily (no more than once every four hours). Do not apply it to broken or inflamed skin.
After use it is important to wash one's hands thoroughly. Capsaicin cream is made from chillies. If any of it gets into the patients eyes, mouth, nose or genitals it is likely to cause pain (without damage).
When first applying capsaicin cream onto the skin there may be a burning sensation, this is normal. After some use that sensation goes away. Avoid having a hot bath or shower before or after applying the cream.
Intra-articular injections (cortisone shots) - in some cases pain symptoms may be so severe that analgesics (painkillers) are not enough. In such cases the medication may be injected directly into the site of the joint. Usually, these will be injections of corticosteroids. Corticosteroids are effective for pain relief and to reduce swelling. The National Institute of Health and Clinical Excellence (NICE), UK, which decides on approved treatments for the National Health Service (NHS), does not recommend intra-articular injections of hyaluronic acid for osteoarthritis.
Each joint should not be treated in this way more than three times a year. Too many intra-articular injections can damage the joint.
Treatment with a physical therapist (UK: physiotherapist)
TENS (transcutaneous electrical nerve stimulation) - this is the application of electrical current through the skin for pain control. A TENS unit is usually connected to the skin using two or more electrodes. It works by numbing the nerves endings in the spinal cord that control pain.
Thermotherapy - warm and cold temperatures are used to help reduce pain and stiffness in the joints. For example, a hot water bottle is filled with either hot or cold water and applied to the affected area. Some patients find this therapy helps with pain. Alternatively, hot and cold packs may be used - they are either cooled in the freezer or heated up in a microwave oven.
Manual therapy - this treatment is performed by a physical therapist who uses stretching techniques to keep the joints flexible and supple. If the patient is not using the affected joint the muscle may weaken, further worsening osteoarthritis stiffness.
Assistive devices - in some cases osteoarthritis may cause problems with mobility. The patient may find everyday tasks difficult to do. There several devices which may help. Most doctors refer their patient to either an occupational therapist, a physical therapist, or both.
Problems with the lower limbs - people whose hips, knees or feet are affected may benefit from wearing special footwear, or shoe-insoles. Some shock-absorbing soles can reduce the pressure on the joints. Special insoles may help distribute bodyweight more evenly. Some patients may find that leg braces help.
Holding a stick or cane on the opposite side of the body to the affected leg may help.
If the patient needs to rest a painful joint a splint may help. A splint is a piece of rigid material that provides joint or bone support.
Hand problems - special devices, such as tap-turners can make everyday tasks easier. An occupational therapist is trained to help people carry out their everyday tasks more easily at home and in the workplace.
Surgery - this may sometimes help patients with osteoarthritis that affects their hips, knees, joints, and at the base of their thumbs. However, in most cases surgery is not needed, and is only usually recommended if other therapies have been ineffective, or if one of the joints is severely damaged.
The doctor will refer the patient to an orthopedic surgeon before symptoms become too severe, or before the osteoarthritis causes to much permanent damage. Examples of surgery include:
Arthroplasty (joint replacement) - total replacement of the joint. The damaged parts are surgically removed and a prosthesis (artificial joint) made of metal and plastic is inserted. The most commonly replaced joints are the hip and knee joints. However, implants can currently replace the joints in the shoulder, finger, ankle and elbow. Arthroplasty is usually very effective, allowing the patient to use the joint actively and painlessly. Arthroplasty of the hand joints can help their appearance, as well as their function. There is a small risk of infection and bleeding. Sometimes they may come loose or wear down, and may need to be replaced (eventually).
Arthrodesis - if a joint replacement is not an option, the joint may be surgically fixed to promote a bone fusion; the joint is realigned or stabilized. Also called artificial ankylosis, syndesis. This increases stability and reduces pain. If the joint in the ankle is fused the patient will be able to bear weight on it painlessly - however, it will have no flexibility.
Osteotomy - the surgeon adds or removes a small section of bone either above or below the knee joint to realign the leg so that the patient's weight is no longer focused on the damaged part of the joint. This procedure may be used if the patient is too young for knee replacement surgery (arthroplasty). Although this procedure helps relieve symptoms significantly, there may be a need for knee replacement surgery later on.
Osteoarthritis self-help
There are several things patients can do to help ease the symptoms of osteoarthritis. A doctor or physical therapist should be able to offer useful advice on lifestyle changes. Some patients may only need the changes listed below to keep their symptoms under control:
Exercise - even though the idea of doing exercise when a patient's joints are stiff and painful may seem odd, exercise is a key part of osteoarthritis treatment. Exercise helps:
Keep the patient active and mobile
Build up muscle, resulting in stronger joints
Relieve mental and emotional stress
Help achieve body weight control
Improve posture
All the above-mentioned benefits of exercise help reduce osteoarthritis symptoms.
Patients who have a good doctor or physical therapist should be able to devise an effective and suitable exercise program, which can be done at home or at the local gym. Many gyms today are geared up to help people with arthritis. The patient needs to follow the program carefully, and make sure he/she does not do the wrong exercises or do the exercises incorrectly, which may cause damage.
An exercise plan will probably focus on improving the patient's:
Flexibility - to help with the range of movement. This will involve gently stretching the joints, making them suppler.
Strength - to improve muscle tone and strength.
Fitness - to improve stamina. This may involve swimming, walking or cycling.
Weight control - the more overweight/obese patients are, the worse their osteoarthritis symptoms will be, simply because there is much more weight bearing down on the joints, especially if the affected joints are in the lower limbs.
Losing weight, and maintaining ideal body weight involves eating properly, doing exercise, and sleeping at least 7.5 hours each day. Patients should consult with a doctor, physical therapist or nutritionist before embarking on any exercise program or special diet.
What are the possible complications of osteoarthritis?
Mobility - some patients may find it hard to move around. There is a greater risk of trips and falls, and their subsequent injuries.
Disability - it is not true that osteoarthritis eventually leads to disability. In the majority of cases the condition does cause pain and discomfort, but no permanent disability. In some cases though, it can sometimes eventually leave the patient disabled.
Work - some patients may find that osteoarthritis symptoms interfere with their ability to work properly. This can result in frustration, irritability and depression. Patients who experience psychological problems should tell their GP or occupational therapist. Talking to one's employer often helps too.
Septic arthritis - this is joint inflammation caused by bacteria infecting the joint. Patients who undergo arthroplasty (joint replacement surgery) run a small risk of infection. Septic arthritis is a medical emergency, and the patient needs to be hospitalized. Treatment involves antibiotic medication and drainage of the infected joint fluid from the joint.
Written by
пятница, 1 июля 2011 г.
FDA Expands ENBREL Psoriatic Arthritis Indication
Amgen Inc and Wyeth Pharmaceuticals, a division of Wyeth, today announced that the US Food and Drug Administration (FDA)
approved an expanded indication for Enbrel(R) (etanercept) to improve physical function in patients with psoriatic arthritis.
ENBREL is the first and only treatment to receive this expanded indication. In addition, the FDA approved an update to the
ENBREL label to include new radiographic data demonstrating that ENBREL continued to inhibit the progression of joint
destruction for two years among most psoriatic arthritis patients who received ongoing therapy.
ENBREL received its approval to treat signs and symptoms of psoriatic arthritis in 2002. With this expanded approval, ENBREL
is now indicated for reducing signs and symptoms, inhibiting the progression of joint destruction of active arthritis
associated with psoriatic arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL is also
approved to treat moderate-to-severe rheumatoid arthritis and juvenile rheumatoid arthritis, ankylosing spondylitis and
moderate-to-severe plaque psoriasis.
"This approval for improving physical function and the addition of the two-year radiographic data builds on the
well-established efficacy and safety profile of ENBREL in psoriatic arthritis. No other treatment has been FDA-approved to
provide efficacy for psoriatic arthritis patients using these multiple clinical measures," said Will Dere, M.D., chief
medical officer and senior vice president of global development, Amgen. "ENBREL is unique because it has received 10 FDA
approvals in five distinct diseases and has been used by more than 280,000 patients worldwide across indications. ENBREL also
has 12 years of collective clinical experience."
The expanded approval of ENBREL was based on significant improvements in physical function as assessed by the disability
index of the Health Assessment Questionnaire (HAQ), a test used to evaluate a patient's ability to perform daily activities
such as dressing, walking and grooming, and the Medical Outcomes Study Short-Form Health Survey (SF-36), a measurement tool
that also assesses the physical impact of a disease.
Almost 40 percent of psoriatic arthritis patients taking ENBREL in this study achieved a HAQ score of zero, indicating no
functional disability at 24 weeks. In addition, the SF-36 found that many patients treated with ENBREL experienced a greater
improvement from baseline, compared to placebo, in their ability to participate in physical activities such as walking,
carrying groceries, or climbing a flight of stairs.
Psoriatic arthritis is a chronic, often destructive disease characterized by both joint inflammation and erosion, and is
associated with psoriatic skin lesions. The progressive joint pain and swelling, which is often coupled with painful, scaly,
red skin lesions, can disrupt a person's ability to perform activities of daily life that most people take for granted such
as getting dressed, eating or walking. Approximately one million people suffer from psoriatic arthritis in the United States.
"We are pleased that ENBREL has shown the ability to inhibit the progression of joint destruction for a continuous two years
in most psoriatic arthritis patients in this study, which is vital in helping to ease the debilitating effects of this
disease," said Gary L. Stiles, M.D., executive vice president and chief medical officer of Wyeth Pharmaceuticals. "Similar to
rheumatoid arthritis, ENBREL is the only treatment approved to provide long-term inhibition of joint destruction for most
patients."
ABOUT ENBREL
ENBREL is the only soluble tumor necrosis factor (TNF) receptor approved to reduce signs and symptoms, induce major clinical
response, improve physical function, and inhibit the progression of structural damage in patients with moderately to severely
active rheumatoid arthritis (RA). ENBREL can be used alone or in combination with methotrexate.
ENBREL is the only treatment indicated to reduce the signs and symptoms, inhibit the progression of structural damage of
active arthritis, and improve physical function in patients with psoriatic arthritis. It is approved to reduce the signs and
symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients four years of
age or older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). It is also
the first biologic approved to reduce the signs and symptoms in patients with active ankylosing spondylitis (AS). ENBREL is
indicated for the treatment of adult patients (18 years or older) with chronic moderate-to-severe plaque psoriasis who are
candidates for systemic therapy or phototherapy.
ENBREL has been used by more than 280,000 patients worldwide across indications.
ENBREL acts by binding TNF, one of the dominant inflammatory cytokines or regulatory proteins that play an important role in
both normal immune function and the cascade of reactions involved in the inflammatory process of RA, JRA, psoriasis,
psoriatic arthritis, and AS. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in
significant reduction in inflammatory activity.
What important information do I need to know about taking ENBREL?
ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body's
immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis,
psoriatic arthritis, and psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of TNF in the body to
normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to
fight infections.
All medicines have side effects, including ENBREL. Possible side effects of ENBREL include:
-- Serious infections
-- Many occurred in people prone to infection, such as those
with advanced or poorly controlled diabetes
-- Some serious infections have been fatal
-- Rare cases of tuberculosis have occurred
-- What not to do
-- Do not start ENBREL if you have an infection or are
allergic to ENBREL or its components
-- What to do
-- Tell your doctor if you are prone to infection
-- Stop ENBREL if a serious infection occurs
-- Contact your doctor if you have questions about ENBREL or
develop an infection
-- Tell your doctor if you have ever been treated for heart
failure
-- Serious nervous system disorders such as multiple sclerosis,
seizures, or inflammation of the nerves of the eyes
-- Tell your doctor if you have ever had any of these
disorders or if you develop them after starting ENBREL
-- Rare reports of serious blood disorders (some fatal)
-- Contact your doctor immediately if you develop symptoms
such as persistent fever, bruising, bleeding, or paleness
-- In medical studies of all TNF blockers, including ENBREL, a
higher rate of lymphoma (a type of cancer) was seen compared
to the general population. The risk of lymphoma may be up to
several fold higher in rheumatoid arthritis and psoriasis
patients
-- The role of TNF blockers, including ENBREL, in the
development of lymphoma is unknown
-- ENBREL can cause injection site reactions.
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Wyeth markets ENBREL outside of North
America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL. Additional information about ENBREL,
including full Prescribing Information, can be found on the website sponsored by the companies at ENBREL or by
calling toll free 888-4ENBREL (888-436-2735).
Amgen is a global biotechnology company that discovers, develops, manufactures, and markets important human therapeutics
based on advances in cellular and molecular biology.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease,
central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one
of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery,
development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products, and nonprescription medicines
that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth
Consumer Healthcare, and Fort Dodge Animal Health.
This news release contains forward-looking statements that involve significant risks and uncertainties, including those
discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2004, and in Amgen's
periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does
not undertake any obligation to update any forward-looking statements contained in this document as a result of new
information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery
or identification of new product candidates or development of new indications for existing products cannot be guaranteed and
movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate
or development of a new indication for an existing product will be successful and become a commercial product. Further,
preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes even adequately, modeled by computer or cell culture systems or animal models.
The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing
has in the past varied, and Amgen expects similar variability in the future. Amgen develops product candidates internally and
through licensing collaborations, partnerships, and joint ventures. Product candidates that are derived from relationships
may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at
the time of entering into such relationship. Also, Amgen or others could identify side effects or manufacturing problems with
Amgen's products after they are on the market.
In addition, sales of Amgen's products are affected by the availability of reimbursement and the reimbursement policies
imposed by third-party payors, including governments, private insurance plans, and managed care providers, and may be
affected by domestic and international trends toward managed care and health care cost containment as well as possible U.S.
legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect
the development, usage, and pricing of our products. In addition, Amgen competes with other companies with respect to some of
Amgen's marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer
products, product candidates, or new indications for existing products, may face competition when and as they are approved
and marketed. Amgen's products may compete against products that have lower prices, established reimbursement, superior
performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen
routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may
be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen's ability to obtain or
maintain patent protection for its products or product candidates. Amgen cannot guarantee that it will be able to produce
commercially successful products or maintain the commercial success of its existing products. Amgen's stock price may be
affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product
candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate
an entire class of products could have a material adverse effect on sales of the affected products and on our business and
results of operations.
The scientific information discussed in this news release related to Amgen's product candidates is preliminary and
investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions
can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether
the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information
discussed in this news release relating to new indications for our products is preliminary and investigative and is not part
of the labeling approved by the FDA for the products. The products are not approved for the investigational use(s) discussed
in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for
these uses.
Only the FDA can determine whether the products are safe and effective for these uses. Health care professionals should refer
to and rely upon the FDA-approved labeling for the products and not the information discussed in this news release.
The statements in this press release that are not historical facts are forward-looking statements based on current
expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the
inherent uncertainty of the timing and success of pharmaceutical research, product development, manufacturing,
commercialization, economic conditions including interest and currency exchange rate fluctuations, changes in generally
accepted accounting principles, the impact of competitive or generic products, trade buying patterns, wars or terrorist acts,
product liability and other types of lawsuits, the impact of legislation and regulatory compliance and obtaining
reimbursement, favorable drug pricing, access and other approvals, environmental liabilities, and patent, and other risks and
uncertainties, including those detailed from time to time in the Company's periodic reports, including current reports on
Form 8-K, quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange
Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to
publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
amgen/media
View drug information on Enbrel.
approved an expanded indication for Enbrel(R) (etanercept) to improve physical function in patients with psoriatic arthritis.
ENBREL is the first and only treatment to receive this expanded indication. In addition, the FDA approved an update to the
ENBREL label to include new radiographic data demonstrating that ENBREL continued to inhibit the progression of joint
destruction for two years among most psoriatic arthritis patients who received ongoing therapy.
ENBREL received its approval to treat signs and symptoms of psoriatic arthritis in 2002. With this expanded approval, ENBREL
is now indicated for reducing signs and symptoms, inhibiting the progression of joint destruction of active arthritis
associated with psoriatic arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL is also
approved to treat moderate-to-severe rheumatoid arthritis and juvenile rheumatoid arthritis, ankylosing spondylitis and
moderate-to-severe plaque psoriasis.
"This approval for improving physical function and the addition of the two-year radiographic data builds on the
well-established efficacy and safety profile of ENBREL in psoriatic arthritis. No other treatment has been FDA-approved to
provide efficacy for psoriatic arthritis patients using these multiple clinical measures," said Will Dere, M.D., chief
medical officer and senior vice president of global development, Amgen. "ENBREL is unique because it has received 10 FDA
approvals in five distinct diseases and has been used by more than 280,000 patients worldwide across indications. ENBREL also
has 12 years of collective clinical experience."
The expanded approval of ENBREL was based on significant improvements in physical function as assessed by the disability
index of the Health Assessment Questionnaire (HAQ), a test used to evaluate a patient's ability to perform daily activities
such as dressing, walking and grooming, and the Medical Outcomes Study Short-Form Health Survey (SF-36), a measurement tool
that also assesses the physical impact of a disease.
Almost 40 percent of psoriatic arthritis patients taking ENBREL in this study achieved a HAQ score of zero, indicating no
functional disability at 24 weeks. In addition, the SF-36 found that many patients treated with ENBREL experienced a greater
improvement from baseline, compared to placebo, in their ability to participate in physical activities such as walking,
carrying groceries, or climbing a flight of stairs.
Psoriatic arthritis is a chronic, often destructive disease characterized by both joint inflammation and erosion, and is
associated with psoriatic skin lesions. The progressive joint pain and swelling, which is often coupled with painful, scaly,
red skin lesions, can disrupt a person's ability to perform activities of daily life that most people take for granted such
as getting dressed, eating or walking. Approximately one million people suffer from psoriatic arthritis in the United States.
"We are pleased that ENBREL has shown the ability to inhibit the progression of joint destruction for a continuous two years
in most psoriatic arthritis patients in this study, which is vital in helping to ease the debilitating effects of this
disease," said Gary L. Stiles, M.D., executive vice president and chief medical officer of Wyeth Pharmaceuticals. "Similar to
rheumatoid arthritis, ENBREL is the only treatment approved to provide long-term inhibition of joint destruction for most
patients."
ABOUT ENBREL
ENBREL is the only soluble tumor necrosis factor (TNF) receptor approved to reduce signs and symptoms, induce major clinical
response, improve physical function, and inhibit the progression of structural damage in patients with moderately to severely
active rheumatoid arthritis (RA). ENBREL can be used alone or in combination with methotrexate.
ENBREL is the only treatment indicated to reduce the signs and symptoms, inhibit the progression of structural damage of
active arthritis, and improve physical function in patients with psoriatic arthritis. It is approved to reduce the signs and
symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients four years of
age or older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). It is also
the first biologic approved to reduce the signs and symptoms in patients with active ankylosing spondylitis (AS). ENBREL is
indicated for the treatment of adult patients (18 years or older) with chronic moderate-to-severe plaque psoriasis who are
candidates for systemic therapy or phototherapy.
ENBREL has been used by more than 280,000 patients worldwide across indications.
ENBREL acts by binding TNF, one of the dominant inflammatory cytokines or regulatory proteins that play an important role in
both normal immune function and the cascade of reactions involved in the inflammatory process of RA, JRA, psoriasis,
psoriatic arthritis, and AS. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in
significant reduction in inflammatory activity.
What important information do I need to know about taking ENBREL?
ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body's
immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis,
psoriatic arthritis, and psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of TNF in the body to
normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to
fight infections.
All medicines have side effects, including ENBREL. Possible side effects of ENBREL include:
-- Serious infections
-- Many occurred in people prone to infection, such as those
with advanced or poorly controlled diabetes
-- Some serious infections have been fatal
-- Rare cases of tuberculosis have occurred
-- What not to do
-- Do not start ENBREL if you have an infection or are
allergic to ENBREL or its components
-- What to do
-- Tell your doctor if you are prone to infection
-- Stop ENBREL if a serious infection occurs
-- Contact your doctor if you have questions about ENBREL or
develop an infection
-- Tell your doctor if you have ever been treated for heart
failure
-- Serious nervous system disorders such as multiple sclerosis,
seizures, or inflammation of the nerves of the eyes
-- Tell your doctor if you have ever had any of these
disorders or if you develop them after starting ENBREL
-- Rare reports of serious blood disorders (some fatal)
-- Contact your doctor immediately if you develop symptoms
such as persistent fever, bruising, bleeding, or paleness
-- In medical studies of all TNF blockers, including ENBREL, a
higher rate of lymphoma (a type of cancer) was seen compared
to the general population. The risk of lymphoma may be up to
several fold higher in rheumatoid arthritis and psoriasis
patients
-- The role of TNF blockers, including ENBREL, in the
development of lymphoma is unknown
-- ENBREL can cause injection site reactions.
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Wyeth markets ENBREL outside of North
America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL. Additional information about ENBREL,
including full Prescribing Information, can be found on the website sponsored by the companies at ENBREL or by
calling toll free 888-4ENBREL (888-436-2735).
Amgen is a global biotechnology company that discovers, develops, manufactures, and markets important human therapeutics
based on advances in cellular and molecular biology.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease,
central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one
of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery,
development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products, and nonprescription medicines
that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth
Consumer Healthcare, and Fort Dodge Animal Health.
This news release contains forward-looking statements that involve significant risks and uncertainties, including those
discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2004, and in Amgen's
periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does
not undertake any obligation to update any forward-looking statements contained in this document as a result of new
information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery
or identification of new product candidates or development of new indications for existing products cannot be guaranteed and
movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate
or development of a new indication for an existing product will be successful and become a commercial product. Further,
preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes even adequately, modeled by computer or cell culture systems or animal models.
The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing
has in the past varied, and Amgen expects similar variability in the future. Amgen develops product candidates internally and
through licensing collaborations, partnerships, and joint ventures. Product candidates that are derived from relationships
may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at
the time of entering into such relationship. Also, Amgen or others could identify side effects or manufacturing problems with
Amgen's products after they are on the market.
In addition, sales of Amgen's products are affected by the availability of reimbursement and the reimbursement policies
imposed by third-party payors, including governments, private insurance plans, and managed care providers, and may be
affected by domestic and international trends toward managed care and health care cost containment as well as possible U.S.
legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect
the development, usage, and pricing of our products. In addition, Amgen competes with other companies with respect to some of
Amgen's marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer
products, product candidates, or new indications for existing products, may face competition when and as they are approved
and marketed. Amgen's products may compete against products that have lower prices, established reimbursement, superior
performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen
routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may
be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen's ability to obtain or
maintain patent protection for its products or product candidates. Amgen cannot guarantee that it will be able to produce
commercially successful products or maintain the commercial success of its existing products. Amgen's stock price may be
affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product
candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate
an entire class of products could have a material adverse effect on sales of the affected products and on our business and
results of operations.
The scientific information discussed in this news release related to Amgen's product candidates is preliminary and
investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions
can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether
the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information
discussed in this news release relating to new indications for our products is preliminary and investigative and is not part
of the labeling approved by the FDA for the products. The products are not approved for the investigational use(s) discussed
in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for
these uses.
Only the FDA can determine whether the products are safe and effective for these uses. Health care professionals should refer
to and rely upon the FDA-approved labeling for the products and not the information discussed in this news release.
The statements in this press release that are not historical facts are forward-looking statements based on current
expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the
inherent uncertainty of the timing and success of pharmaceutical research, product development, manufacturing,
commercialization, economic conditions including interest and currency exchange rate fluctuations, changes in generally
accepted accounting principles, the impact of competitive or generic products, trade buying patterns, wars or terrorist acts,
product liability and other types of lawsuits, the impact of legislation and regulatory compliance and obtaining
reimbursement, favorable drug pricing, access and other approvals, environmental liabilities, and patent, and other risks and
uncertainties, including those detailed from time to time in the Company's periodic reports, including current reports on
Form 8-K, quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange
Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to
publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
amgen/media
View drug information on Enbrel.
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