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
воскресенье, 10 июля 2011 г.
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."
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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.
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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.
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imposed by third-party payors, including governments, private insurance plans, and managed care providers, and may be
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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
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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
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an entire class of products could have a material adverse effect on sales of the affected products and on our business and
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The scientific information discussed in this news release related to Amgen's product candidates is preliminary and
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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,
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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.
вторник, 28 июня 2011 г.
"ACTEMRA®" Humanized Anti-Human IL-6 Receptor Monoclonal Antibody Conditions For Approval (All Patients Surveillance) Lifted In Japan
Chugai Pharmaceutical Co., Ltd. [Head Office: Chuo-ku, Tokyo; President: Osamu Nagayama (hereafter, "Chugai") announced that it has received a notification from the Japanese Ministry of Health, Labour and Welfare(MHLW) that the conditions for approval (surveillance of all patients1) are lifted with "rheumatoid arthritis(RA)" and "polyarticular-course juvenile idiopathic arthritis (pJIA)" indications for the humanized anti-human IL-6 receptor monoclonal antibody, ACTEMRA®.
For ACTEMRA®, additional approval of indications of "RA (including prevention of structural damage of joints)," "pJIA" and "systemic-onset juvenile idiopathic arthritis (sJIA)" was obtained in April 2008. As one of the conditions for this approval, it had been required that "data on the safety and efficacy of this drug shall be swiftly collected by conducting surveillance of uses in all patients and that the necessary measures shall be taken for the proper use of the drug until data on a certain number of patients is accumulated after marketing."
Data on 3,987 patients with RA and pJIA was submitted to the Japanese MHLW as the interim analysis results of the above surveillance*2. Based on the results, it has been determined that there is no problem necessitating additional measures for the safety and efficacy of this drug at this time. Accordingly, the conditions for approval involving the all patient surveillance have been lifted. For the surveillance, over 10,000 patients have been enrolled up to date. The final analysis of safety data will be done on the 8,300 patients enrolled by November 15, 2009, and will be reported as soon as they become available.
Among the indications of this drug, surveillance of all patients with sJIA and Castleman's disease is still conducted and new patients continue to be enrolled.
ACTEMRA®, the first antibody drug (humanized monoclonal antibody) originating from Japan, was created by Chugai in collaboration with Osaka University, utilizing genetic recombinant technology to produce a monoclonal antibody against the anti-IL6 receptor. It works by inhibiting biological activity of IL-6 through competitively blocking the binding of IL-6 to its receptor.
Rheumatoid arthritis is a systemic inflammatory disease that mainly causes progressive and multiple joint destructions, for which the cause is unknown. It appears more commonly in females in their 40s and 50s, and the disease is causing serious psychological and social problems not only for the patients but also for their families, and measures to counter the disease are seriously needed. Patients are often forced to spend a long time fighting the disease, causing various difficulties in social life such as school life and employment.
Chugai focuses on bone and joint diseases area as one of the strategic domains, and hopes to contribute to the treatment by providing innovative therapeutic options for patients and medical professionals. The company will continue to make efforts for promoting the proper use and supplying information while giving the highest priority to the safety of patients.
References
1. Objective of surveillance of all patients
For those patients who receive treatment with ACTEMRA®, the data will be evaluated in order to obtain information on the safety (adverse effects of the drug) and efficacy of the drug at an early date and to ensure the safe use of the drug.
2. Result of interim analysis
For the interim analysis, data on 3,987 patients with RA (3,881 patients) and pJIA (106 patients) who were enrolled between April 16, 2008 and July 15, 2009 was evaluated.
Rheumatoid arthritis
-- The incidence of adverse drug reaction was 37.9%, in which the incidence of serious adverse drug reactions accounted for 8.0%. The most frequent adverse drug reactions were "abnormal laboratory test values" and "infections and infestations." The most frequent serious adverse drug reactions were "infections and infestations" including pneumonia. The safety profile was almost the same as in the clinical trials.
-- The efficacy was evaluated using DAS28. Among 2,072 patients whose DAS28 values were collected before the administration of ACTEMRA® and at the 28th week, the high disease activity score of DAS28 (mean?±SD) 5.53?±1.30 before administration markedly improved to 3.00?±1.49 at the 28th week. The remission rate at the 28th week was 45.0%.
Polyarticular-course juvenile idiopathic arthritis (pJIA)
-- The incidence of adverse drug reactions was 41.7%, in which the incidence of serious adverse drug reactions accounted for 10.7%. The most frequent adverse drug reactions were "infections and infestations" same as in the case with RA patients.
-- For the efficacy, the general improvement levels at the 28th week were evaluated, showing "markedly effective" in 54.2%, "effective" in 42.2%, "ineffective" in 2.4%, and "cannot be evaluated" in 1.2%.
The Disease Activity Score (DAS)28 is a combined index that measures disease activity in patients with RA. It combines information from 28 tender and swollen joints (range 0-28), erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. The level of disease activity is interpreted as low (DAS28 < 3.2), moderate (3.2 < DAS28 < 5.1) or high (DAS28 >5.1). DAS28
For ACTEMRA®, additional approval of indications of "RA (including prevention of structural damage of joints)," "pJIA" and "systemic-onset juvenile idiopathic arthritis (sJIA)" was obtained in April 2008. As one of the conditions for this approval, it had been required that "data on the safety and efficacy of this drug shall be swiftly collected by conducting surveillance of uses in all patients and that the necessary measures shall be taken for the proper use of the drug until data on a certain number of patients is accumulated after marketing."
Data on 3,987 patients with RA and pJIA was submitted to the Japanese MHLW as the interim analysis results of the above surveillance*2. Based on the results, it has been determined that there is no problem necessitating additional measures for the safety and efficacy of this drug at this time. Accordingly, the conditions for approval involving the all patient surveillance have been lifted. For the surveillance, over 10,000 patients have been enrolled up to date. The final analysis of safety data will be done on the 8,300 patients enrolled by November 15, 2009, and will be reported as soon as they become available.
Among the indications of this drug, surveillance of all patients with sJIA and Castleman's disease is still conducted and new patients continue to be enrolled.
ACTEMRA®, the first antibody drug (humanized monoclonal antibody) originating from Japan, was created by Chugai in collaboration with Osaka University, utilizing genetic recombinant technology to produce a monoclonal antibody against the anti-IL6 receptor. It works by inhibiting biological activity of IL-6 through competitively blocking the binding of IL-6 to its receptor.
Rheumatoid arthritis is a systemic inflammatory disease that mainly causes progressive and multiple joint destructions, for which the cause is unknown. It appears more commonly in females in their 40s and 50s, and the disease is causing serious psychological and social problems not only for the patients but also for their families, and measures to counter the disease are seriously needed. Patients are often forced to spend a long time fighting the disease, causing various difficulties in social life such as school life and employment.
Chugai focuses on bone and joint diseases area as one of the strategic domains, and hopes to contribute to the treatment by providing innovative therapeutic options for patients and medical professionals. The company will continue to make efforts for promoting the proper use and supplying information while giving the highest priority to the safety of patients.
References
1. Objective of surveillance of all patients
For those patients who receive treatment with ACTEMRA®, the data will be evaluated in order to obtain information on the safety (adverse effects of the drug) and efficacy of the drug at an early date and to ensure the safe use of the drug.
2. Result of interim analysis
For the interim analysis, data on 3,987 patients with RA (3,881 patients) and pJIA (106 patients) who were enrolled between April 16, 2008 and July 15, 2009 was evaluated.
Rheumatoid arthritis
-- The incidence of adverse drug reaction was 37.9%, in which the incidence of serious adverse drug reactions accounted for 8.0%. The most frequent adverse drug reactions were "abnormal laboratory test values" and "infections and infestations." The most frequent serious adverse drug reactions were "infections and infestations" including pneumonia. The safety profile was almost the same as in the clinical trials.
-- The efficacy was evaluated using DAS28. Among 2,072 patients whose DAS28 values were collected before the administration of ACTEMRA® and at the 28th week, the high disease activity score of DAS28 (mean?±SD) 5.53?±1.30 before administration markedly improved to 3.00?±1.49 at the 28th week. The remission rate at the 28th week was 45.0%.
Polyarticular-course juvenile idiopathic arthritis (pJIA)
-- The incidence of adverse drug reactions was 41.7%, in which the incidence of serious adverse drug reactions accounted for 10.7%. The most frequent adverse drug reactions were "infections and infestations" same as in the case with RA patients.
-- For the efficacy, the general improvement levels at the 28th week were evaluated, showing "markedly effective" in 54.2%, "effective" in 42.2%, "ineffective" in 2.4%, and "cannot be evaluated" in 1.2%.
The Disease Activity Score (DAS)28 is a combined index that measures disease activity in patients with RA. It combines information from 28 tender and swollen joints (range 0-28), erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. The level of disease activity is interpreted as low (DAS28 < 3.2), moderate (3.2 < DAS28 < 5.1) or high (DAS28 >5.1). DAS28
суббота, 25 июня 2011 г.
Impact Sports Increase Bone Strength In Senior Athletes
Running, basketball and other
high-impact sports may lead to stronger bones as people age, according to a
new study presented today at the 74th Annual Meeting of the American
Academy of Orthopaedic Surgeons. Measurements conducted on senior Olympic
athletes found that the bone mineral density (BMD) for those who
participated in impact sports was significantly greater than athletes who
competed in low-impact sports like swimming and cycling.
"While we know that exercise is vital as we get older, this study finds
that the kind of exercise we choose can be just as important," said Vonda
Wright, MD, lead author and assistant professor in the department of
orthopedic surgery at the University of Pittsburgh Medical Center. "The
findings show that a key to maintaining strong, healthy bones as we age is
to engage in impact sports."
The study evaluated 298 athletes competing in the 2005 Senior Olympic
Games in Pittsburgh. The athletes, ages 50 to 93, completed a
health-history questionnaire and underwent ultrasound to measure BMD. The
BMD T-score for athletes in the high-impact group was .4+/-1.3 versus
-1+/-1.4 for athletes in the non-high impact group. After controlling for
age, sex, obesity and osteoporosis medication, participation in high-impact
sports was found to be a significant predictor of BMD.
"The costs associated with caring for people with osteoporosis and
fractures caused by frail bones are rising as the population ages," Dr.
Wright concluded. "Our study implies that persistent participation in
impact sports can positively influence bone health even in the oldest
athletes."
Osteoporosis is a disease of progressive bone loss affecting 28 million
Americans and contributing to an estimated 1.5 million bone fractures per
year. One in two women and one in five men over age 65 will sustain bone
fractures due to osteoporosis.
American Academy of Orthopaedic Surgeons
aaos/
high-impact sports may lead to stronger bones as people age, according to a
new study presented today at the 74th Annual Meeting of the American
Academy of Orthopaedic Surgeons. Measurements conducted on senior Olympic
athletes found that the bone mineral density (BMD) for those who
participated in impact sports was significantly greater than athletes who
competed in low-impact sports like swimming and cycling.
"While we know that exercise is vital as we get older, this study finds
that the kind of exercise we choose can be just as important," said Vonda
Wright, MD, lead author and assistant professor in the department of
orthopedic surgery at the University of Pittsburgh Medical Center. "The
findings show that a key to maintaining strong, healthy bones as we age is
to engage in impact sports."
The study evaluated 298 athletes competing in the 2005 Senior Olympic
Games in Pittsburgh. The athletes, ages 50 to 93, completed a
health-history questionnaire and underwent ultrasound to measure BMD. The
BMD T-score for athletes in the high-impact group was .4+/-1.3 versus
-1+/-1.4 for athletes in the non-high impact group. After controlling for
age, sex, obesity and osteoporosis medication, participation in high-impact
sports was found to be a significant predictor of BMD.
"The costs associated with caring for people with osteoporosis and
fractures caused by frail bones are rising as the population ages," Dr.
Wright concluded. "Our study implies that persistent participation in
impact sports can positively influence bone health even in the oldest
athletes."
Osteoporosis is a disease of progressive bone loss affecting 28 million
Americans and contributing to an estimated 1.5 million bone fractures per
year. One in two women and one in five men over age 65 will sustain bone
fractures due to osteoporosis.
American Academy of Orthopaedic Surgeons
aaos/
среда, 22 июня 2011 г.
EntreMed Presents Data Demonstrating Antiangiogenic Activity Of 2ME2 In Rheumatoid Arthritis
EntreMed, Inc.
(Nasdaq: ENMD), a clinical-stage pharmaceutical company developing
therapeutics for the treatment of cancer and inflammatory diseases today
announced the presentation of preclinical data for its lead compound, 2-
methoxyestradiol (2ME2), in rheumatoid arthritis (RA). Data were presented
earlier today by EntreMed collaborator, Dr. Ernest Brahn, Professor of
Medicine and Rheumatology Program Director, Division of Rheumatology,
University of California Los Angeles, School of Medicine during an oral
presentation at the Annual European Congress of Rheumatology EULAR 2006
being held this week in Amsterdam, The Netherlands.
Results from studies in a preclinical arthritis model of chronic
autoimmune inflammatory joint disease demonstrated that daily oral
administration of 2ME2 resulted in a statistically significant reduction in
clinical severity of joint inflammation and inhibition of articular joint
damage as determined by blinded high resolution radiographs of bone
erosions. The inhibition of disease progression by 2ME2 treatment was based
on histological analyses of tissue parameters that included inhibition of
(a) white blood cell infiltration; (b) pannus (destruction joint tissue)
severity; and (c) cartilage breakdown.
One of the mechanisms by which 2ME2 exerts DMARD activity in the
preclinical arthritis model involves the inhibition of angiogenesis, which
is necessary to support the growth of the pannus. Further tissue analyses
on the articular joints from 2ME2-treated models demonstrated decreased von
Willebrand factor expression indicating a loss or inhibition of
vascularity. In addition, RT-PCR on dissected synovial tissue showed
suppression in the gene expression of the angiogenic growth factors, VEGF
and FGF-2. These data further support the potential for 2ME2 as a disease
modifying anti-rheumatic drug (DMARD).
Dr. Brahn commented on the results of the study, "These preclinical
data further define the impact of 2ME2 on inflammation and disease
progression and indicate that 2ME2 may represent a novel agent for the
treatment of rheumatoid arthritis. The demonstration that 2ME2 inhibits
angiogenesis in this model of rheumatoid arthritis now establishes a
mechanistic link that leads to the involution of collagen-induced
arthritis."
EntreMed Vice President and Chief Medical Officer, Carolyn F. Sidor,
M.D., M.B.A, commented on the study results, "We continue to generate
positive preclinical data demonstrating the effect of 2ME2 on inflammation
and disease progression in well-accepted preclinical models of rheumatoid
arthritis. Angiogenesis is a needed component of pannus growth in
rheumatoid arthritis, and 2ME2, which has antiangiogenic properties, may
represent a novel oral, non-immunologic DMARD approach to treating this
disease. We will continue to explore 2ME2's DMARD activity in preclinical
rheumatoid arthritis models with the intent of supporting clinical
development in RA in addition to our Phase 2 oncology program."
About Rheumatoid Arthritis
Rheumatoid arthritis affects over 2 million American adults, of which
about two-thirds of them are women. The disease, characterized by pain,
stiffness, swelling, and deformity can become debilitating. Within 5 years
of diagnosis, a third of patients are no longer working, and within 10
years, half of the patients have substantial functional disability. RA can
shorten life expectancy by 5-10 years.
Rheumatoid arthritis (RA), one of the most common forms of arthritis,
is a systemic disease characterized by inflammation of the membrane lining
of the joint, which causes pain, stiffness, redness, swelling, and loss of
function in the joint. The inflamed joint lining, called the synovium,
releases enzymes that destroy bone and cartilage, causing the joint to lose
its shape and alignment. This process can result in joint pain, loss of
movement, and deformity. DMARDs are drugs that have the ability to slow
down disease progression in rheumatoid arthritis and other autoimmune
diseases.
About EntreMed
EntreMed, Inc. (Nasdaq: ENMD) is a clinical-stage pharmaceutical
company developing therapeutic candidates primarily for the treatment of
cancer and inflammation. Panzem(R) (2-methoxyestradiol or 2ME2), the
Company's lead drug candidate, is currently in Phase 2 clinical trials for
cancer, as well as in preclinical development for rheumatoid arthritis.
MKC-1, an oral cell cycle regulator, is in Phase 2 studies for metastatic
breast cancer. ENMD-1198, a novel tubulin binding agent, is also in Phase 1
studies in advanced cancers. EntreMed's goal is to develop and
commercialize new compounds based on the Company's expertise in
angiogenesis, cell cycle regulation and inflammation -- processes vital to
the treatment of cancer and other diseases, such as rheumatoid arthritis.
Additional information about EntreMed is available on the Company's website
at entremed and in various filings with the Securities and
Exchange Commission.
Forward Looking Statements
This release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act with respect to the outlook
for expectations for future financial or business performance, strategies,
expectations and goals. Forward-looking statements are subject to numerous
assumptions, risks and uncertainties, which change over time.
Forward-looking statements speak only as of the date they are made, and no
duty to update forward-looking statements is assumed. Actual results could
differ materially from those currently anticipated due to a number of
factors, including those set forth in Securities and Exchange Commission
filings under "Risk Factors," including risks relating to the need for
additional capital and the uncertainty of additional funding; risks
associated with the integration of Miikana and its product candidates; the
early-stage products under development; results in preclinical models are
not necessarily indicative of clinical results, uncertainties relating to
preclinical and clinical trials; success in the clinical development of any
products; dependence on third parties; future capital needs; and risks
relating to the commercialization, if any, of the Company's proposed
products (such as marketing, safety, regulatory, patent, product liability,
supply, competition and other risks).
EntreMed, Inc.
entremed
(Nasdaq: ENMD), a clinical-stage pharmaceutical company developing
therapeutics for the treatment of cancer and inflammatory diseases today
announced the presentation of preclinical data for its lead compound, 2-
methoxyestradiol (2ME2), in rheumatoid arthritis (RA). Data were presented
earlier today by EntreMed collaborator, Dr. Ernest Brahn, Professor of
Medicine and Rheumatology Program Director, Division of Rheumatology,
University of California Los Angeles, School of Medicine during an oral
presentation at the Annual European Congress of Rheumatology EULAR 2006
being held this week in Amsterdam, The Netherlands.
Results from studies in a preclinical arthritis model of chronic
autoimmune inflammatory joint disease demonstrated that daily oral
administration of 2ME2 resulted in a statistically significant reduction in
clinical severity of joint inflammation and inhibition of articular joint
damage as determined by blinded high resolution radiographs of bone
erosions. The inhibition of disease progression by 2ME2 treatment was based
on histological analyses of tissue parameters that included inhibition of
(a) white blood cell infiltration; (b) pannus (destruction joint tissue)
severity; and (c) cartilage breakdown.
One of the mechanisms by which 2ME2 exerts DMARD activity in the
preclinical arthritis model involves the inhibition of angiogenesis, which
is necessary to support the growth of the pannus. Further tissue analyses
on the articular joints from 2ME2-treated models demonstrated decreased von
Willebrand factor expression indicating a loss or inhibition of
vascularity. In addition, RT-PCR on dissected synovial tissue showed
suppression in the gene expression of the angiogenic growth factors, VEGF
and FGF-2. These data further support the potential for 2ME2 as a disease
modifying anti-rheumatic drug (DMARD).
Dr. Brahn commented on the results of the study, "These preclinical
data further define the impact of 2ME2 on inflammation and disease
progression and indicate that 2ME2 may represent a novel agent for the
treatment of rheumatoid arthritis. The demonstration that 2ME2 inhibits
angiogenesis in this model of rheumatoid arthritis now establishes a
mechanistic link that leads to the involution of collagen-induced
arthritis."
EntreMed Vice President and Chief Medical Officer, Carolyn F. Sidor,
M.D., M.B.A, commented on the study results, "We continue to generate
positive preclinical data demonstrating the effect of 2ME2 on inflammation
and disease progression in well-accepted preclinical models of rheumatoid
arthritis. Angiogenesis is a needed component of pannus growth in
rheumatoid arthritis, and 2ME2, which has antiangiogenic properties, may
represent a novel oral, non-immunologic DMARD approach to treating this
disease. We will continue to explore 2ME2's DMARD activity in preclinical
rheumatoid arthritis models with the intent of supporting clinical
development in RA in addition to our Phase 2 oncology program."
About Rheumatoid Arthritis
Rheumatoid arthritis affects over 2 million American adults, of which
about two-thirds of them are women. The disease, characterized by pain,
stiffness, swelling, and deformity can become debilitating. Within 5 years
of diagnosis, a third of patients are no longer working, and within 10
years, half of the patients have substantial functional disability. RA can
shorten life expectancy by 5-10 years.
Rheumatoid arthritis (RA), one of the most common forms of arthritis,
is a systemic disease characterized by inflammation of the membrane lining
of the joint, which causes pain, stiffness, redness, swelling, and loss of
function in the joint. The inflamed joint lining, called the synovium,
releases enzymes that destroy bone and cartilage, causing the joint to lose
its shape and alignment. This process can result in joint pain, loss of
movement, and deformity. DMARDs are drugs that have the ability to slow
down disease progression in rheumatoid arthritis and other autoimmune
diseases.
About EntreMed
EntreMed, Inc. (Nasdaq: ENMD) is a clinical-stage pharmaceutical
company developing therapeutic candidates primarily for the treatment of
cancer and inflammation. Panzem(R) (2-methoxyestradiol or 2ME2), the
Company's lead drug candidate, is currently in Phase 2 clinical trials for
cancer, as well as in preclinical development for rheumatoid arthritis.
MKC-1, an oral cell cycle regulator, is in Phase 2 studies for metastatic
breast cancer. ENMD-1198, a novel tubulin binding agent, is also in Phase 1
studies in advanced cancers. EntreMed's goal is to develop and
commercialize new compounds based on the Company's expertise in
angiogenesis, cell cycle regulation and inflammation -- processes vital to
the treatment of cancer and other diseases, such as rheumatoid arthritis.
Additional information about EntreMed is available on the Company's website
at entremed and in various filings with the Securities and
Exchange Commission.
Forward Looking Statements
This release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act with respect to the outlook
for expectations for future financial or business performance, strategies,
expectations and goals. Forward-looking statements are subject to numerous
assumptions, risks and uncertainties, which change over time.
Forward-looking statements speak only as of the date they are made, and no
duty to update forward-looking statements is assumed. Actual results could
differ materially from those currently anticipated due to a number of
factors, including those set forth in Securities and Exchange Commission
filings under "Risk Factors," including risks relating to the need for
additional capital and the uncertainty of additional funding; risks
associated with the integration of Miikana and its product candidates; the
early-stage products under development; results in preclinical models are
not necessarily indicative of clinical results, uncertainties relating to
preclinical and clinical trials; success in the clinical development of any
products; dependence on third parties; future capital needs; and risks
relating to the commercialization, if any, of the Company's proposed
products (such as marketing, safety, regulatory, patent, product liability,
supply, competition and other risks).
EntreMed, Inc.
entremed
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