Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval To Market Generic Mobic(R)

Caraco Pharmaceutical
Laboratories, Ltd., (Amex: CPD) announced today that the U.S. Food and Drug
Administration (FDA) has granted final approval for the Company's
Abbreviated New Drug Application (ANDA) for Meloxicam Tablets.


Caraco's Meloxicam Tablets is the generic equivalent of Boehringer
Ingelheim's Mobic(R) a nonsteroidal anti-inflammatory drug, (NSAID) which
is indicated for the relief of the signs and symptoms of osteoarthritis.
Caraco has two strengths available, 7.5 mg and 15 mg tablets.


Daniel H. Movens, Caraco's Chief Executive Officer said, "We are
pleased to gain this approval and have another product to market, adding
value to our portfolio of products we market in the U.S. It will complement
our current product mix by adding another nonsteroidal anti-inflammatory
product to our line. We plan to launch this product to the market
immediately. This approval brings our total marketed product selection to
22 different products represented by 47 strengths."


Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops,
manufactures and distributes generic and private-label prescription
pharmaceuticals to the nation's wholesalers, distributors, drugstore chains
and managed care providers.


Safe Harbor:


This news release contains forward-looking statements made
pursuant to the safe-harbor provisions of the Private Securities Litigation
Reform Act of 1995. Such statements are based on management's current
expectations and are subject to risks and uncertainties that could cause
actual results to differ materially from those described in the forward-
looking statements. These risks and uncertainties are contained in the
Corporation's filings with the Securities and Exchange Commission and
include: information is of a preliminary nature and may be subject to
adjustment, not obtaining or delays in obtaining FDA approval for new
products, governmental restrictions on the sale of certain products,
dependence on key personnel, development by competitors of new or superior
products or cheaper products or new technology for the production of
products, the entry into the market of new competitors, market and customer
acceptance and demand for new pharmaceutical products, availability of raw
materials, timing and success of product development and launches,
integrity and reliability of the Corporation's data, lack of success of
attaining full compliance with regard to regulatory and cGMP compliance,
experiencing difficulty in managing our recent rapid growth and anticipated
future growth, dependence on limited customer base, occasional credits to
certain customers reflecting price reductions on products previously sold
to them and still available as shelf- stock, possibility of an incorrect
estimate of charge-backs and the impact of such an incorrect estimate on
net sales, gross profit and net income, dependence on few products
generating majority of sales, product liability claims for which the
Company may be inadequately insured, subjectivity in judgment of management in applying certain significant accounting policies derived based on historical experience, terms of contracts, our observations of trends of
industry, information received from our customers and other sources, to
estimate revenues, accounts receivable allowances including chargebacks,
rebates, income taxes, values of assets and inventories, litigation
involving claims of patent infringement, litigation involving claims for
royalties relating to a prior contract for one product and other risks
identified in this report and identified from time to time in our reports
and registration statements filed with the Securities and Exchange
Commission. These forward-looking statements represent our judgment as of
the date of this report. We disclaim, however, any intent or obligation to
update our forward-looking statements.


Caraco Pharmaceutical Laboratories, Ltd.

Caraco Pharmaceutical Laboratories

Fibromyalgia Sufferers Could Benefit From A Regular Dip

Patients suffering from fibromyalgia could benefit significantly from regular exercise in a heated swimming pool, a study published in the open access journal Arthritis Research & Therapy shows. The findings suggest a cost effective way of improving quality of life for patients with this often-debilitating disorder.



Fibromyalgia is a common, painful syndrome, with no known cause and no accepted cure. Symptoms usually involve chronic and severe pain and tenderness in muscles, ligaments and tendons. Pain in the neck and shoulders is common but sufferers also report problems with sleep, anxiety and depression. More than 90 percent of sufferers are female. Physicians usually prescribe painkillers together with exercise and relaxation techniques, but they may also prescribe a low-dose antidepressant.



Now, Narc?­s Gusi of the Faculty of Sports Sciences, at the University of Extremadura, in C??ceres, Spain and Pablo Tomas-Carus of the Department of Sport and Health at the University of ?‰vora, Portugal have carried out a randomized controlled trial with a group of 33 female fibromyalgia patients to find an alternative approach. Seventeen of the patients took part in supervised training exercises in warm water for an hour three times a week over a period of 8 months while the remaining sixteen did no aquatic training.



Gusi and Tomas-Carus found that this long-term aquatic exercise program was effective in reducing symptoms and improving the health-related quality of life of the participants. In an earlier study, the researchers had shown that even a short-term exercise regime could reduce symptoms but pain would return once the patients stopped the exercise course.



"The addition of an aquatic exercise programme to the usual care for fibromyalgia in women, is cost-effective in terms of both health care costs and societal costs," the researchers conclude, "appropriate aquatic exercise is a good health investment." The researchers are yet to compare aquatic training with more accessible and cheaper forms of exercise, such as low-impact aerobics, walking, and tai-chi.







1. Cost-utility of an 8-month aquatic training for women with fibromyalgia: a randomized controlled trial

Narcis Gusi and Pablo Tomas-Carus

Arthritis Research & Therapy (in press)



Article available at the journal website: arthritis-research/


All articles are available free of charge, according to BioMed Central's open access policy.




2. Arthritis Research & Therapy is an international, peer-reviewed online and print journal, publishing original research, reviews, commentaries and reports. Studies relate to the rationale and treatment of arthritis, autoimmune disease and diseases of bone and cartilage. The journal is edited by Prof Peter E Lipsky (USA) and Prof Sir Ravinder N Maini (UK) and has an Impact Factor of 3.8.



3. BioMed Central (biomedcentral/) is an independent online publishing house committed to providing immediate access without charge to the peer-reviewed biological and medical research it publishes. This commitment is based on the view that open access to research is essential to the rapid and efficient communication of science.



Source: Charlotte Webber


BioMed Central

Skin Cancer Breakthrough: Arthritis Drug Could Be New Weapon Against Melanoma

Leflunomide, a drug commonly used to treat rheumatoid arthritis, may also inhibit the growth of malignant melanoma, a
deadly form of skin cancer, according to new research led by the University of East Anglia (UAE) in the UK and Children's
Hospital Boston in the US.


You can read how UAE researchers Dr Grant Wheeler and Dr Matt Tomlinson and colleagues made the discovery in a paper
published online in Nature this week.


The breakthrough discovery is exciting scientists and clinicians because it takes much less time to trial a drug that is already
licensed for another disease than it does for one never previously tested, leading to speculation that this treatment might be
available in the next five years.


Wheeler, of UEA's School of Biological Sciences, told the press that deaths from melanoma are increasing, and we desperately need
new and better treatments.


"We are very optimistic that this research will lead to novel treatments for melanoma tumors which, working alongside other
therapies, will help to stop them progressing," he added.


For the study, Wheeler, Tomlinson and colleagues screened thousands of compounds looking for likely candidates by testing their
ability to affect the development of pigment cells in tadpoles.


They used tadpole pigment cells because they are similar to human melanocytes that produce melanin, the pigment that is mainly
responsible for skin colour. Melanoma occurs when melanocytes grow in an uncontrolled manner.


The researchers found a number of likely candidates, and after testing them on lab mice, found that leflunomide significantly
restricted tumour growth.


They also tested the effect of combining leflunomide with PLX4720, a promising new drug that is currently being tested as a
treatment for melanoma, and found it almost halted tumor growth completely.


The next stage will be to carry out clinical trials of leflunomide as a treatment for melanoma, and because it is already licensed
for the treatment of arthritis, should the trials prove successful, it could be available in about five years, which is half the usual
timescale for a new drug.


In another paper in the same issue of Nature, some of the researchers from this study describe how they and other
colleagues used zebrafish to identify a new gene called SETDB1 that is responsible for promoting melanoma.


Surprisingly, melanocytes, the pigment-producing cells in humans and tadpoles, are also responsible for producing the dark stripes
on zebrafish.


To find the gene, the researchers at Children's Hospital Boston developed a transgenic zebrafish that had two other features that
lead to melanoma: the correct mutation of a gene called BRAF, and the absence of the tumor suppressor gene p53.















They started out with a hunch that it took more than mutations in BRAF and the absence of p53 to trigger malignant tumors, and
used the new zebrafish model to painstakingly sift through all the other genes, one by one.


The Xenopus tadpole used at UEA to find leflunomide as a possible treatment for melanoma, and this zebrafish model from
Children's Hospital Boston, are examples of the power of using developmental models to screen large numbers of compounds.



The researchers hope such approaches will help discover even more compounds and genes as candidates for other
diseases.


As lead author Dr Richard White of Children's Hospital Boston and Harvard Medical School explained, knowing more about
cancer is not just a matter of finding mutations in genes, but also about knowing the types of cells that tumors spring
from.


"By studying cancer development in zebrafish and frogs, we gain a unique insight into the very earliest changes that occur in
those cells," said White.


Melanoma is the most aggressive form of skin cancer and, unlike most other cancers, it is on the rise. It accounts for 5% of skin
cancers.


More than 10,000 people are diagnosed with melanoma in the UK every year; in the US this figure was 68,000 in 2009, when
8,700 Americans also died from the disease.


If diagnosed early, melanoma tumors can be safely removed with surgery, but if diagnosed in the advanced stage, the chances of
survival are thin.


About 2,000 people die every year in the UK because their melanoma returns after being removed surgically.


If you spot any changes to the shape or color of existing moles or find a new lump anywhere on your skin, get a doctor to check
them, because these are possible signs of melanoma.


"DHODH modulates transcriptional elongation in the neural crest and melanoma."

Richard Mark White, Jennifer Cech, Sutheera Ratanasirintrawoot, Charles Y. Lin, Peter B. Rahl, Christopher J. Burke, Erin
Langdon, Matthew L. Tomlinson, Jack Mosher, Charles Kaufman, et al.

Nature 471, 518-522, published onlin 23 March 2011

DOI:10.1038/nature09882


Additional source: University of East Anglia (23 Mar 2011)., UMass Medical School (24 Mar 2011).


Written by: , PhD

Scientific Research To Study Rare Genetic Disease Alkaptonuria

Scientists at the University of Liverpool have received ??500,000 to develop a treatment for the rare, genetic disease Alkaptonuria.



Patients being treated for the disorder do not have enough of the enzyme, homogentisic acid oxidase, which causes acid to build up in the body. Some of this acid is eliminated in the urine, but the remainder is deposited in body tissue where it is toxic. The result is ochronosis; the formation of a black pigment which binds to bone, cartilage, and skin.



The research at Liverpool will be funded by the Alkaptonuria (AKU) Society following the organisation's successful bid to the Big Lottery Fund. The research will use models of ochronosis that have been developed at the University. Tissue samples donated by Alkaptonuria patients undergoing joint replacement surgery will also be analysed.



There is no known cure for the disease which affects one in 200,000 people worldwide and can leave sufferers with crippling osteoarthritis in their spine and large joints, heart disease and in need of joint replacement surgery.



Head of Human Anatomy and Cell Biology, Professor Jim Gallagher, said: "The black pigment that leaks into the bloodstream and attaches itself to joint cartilage is the main cause of illness. What is interesting is that the pigment only attaches itself to certain areas of cartilage, whilst other sections remain pigment-free.



"If we can find out why it does this we could prevent the pigment from binding altogether. This would dramatically reduce the risk of arthritis in the joints of Alkaptonuria sufferers. Only by understanding the basic mechanisms of the development of ochronosis will we be able to develop strategies to prevent it."



Scientists will use their ochronosis models to provide a fundamental understanding of the development of the condition and to develop potential therapies.







Notes:



1. The Alkaptonuria (AKU) Society is a patient group providing an information and support network for those diagnosed with the condition. The society has been working with the University of Liverpool for four years to find a treatment for Alkaptonuria. For further information please visit alkaptonuria/.



2. The University of Liverpool is a member of the Russell Group of leading research-intensive institutions in the UK. It attracts collaborative and contract research commissions from a wide range of national and international organisations valued at more than ??108 million annually.



Source: Laura Johnson


University of Liverpool

Anti-inflammatory Effects Of Pomegranate In Rabbits: A Potential Treatment In Humans?

Oral ingestion of pomegranate extract reduces the production of chemicals that cause inflammation suggests a study published in BioMed Central's open access Journal of Inflammation. The findings indicate that pomegranate extract may provide humans with relief of chronic inflammatory conditions.



The group from the Department of Medicine of Case Western Reserve University, Cleveland Ohio, led by Tariq Haqqi, showed that blood samples collected from rabbits fed pomegranate extract inhibited inflammation.



Pomegranate extract is already used as a treatment in alternative medicine for inflammatory conditions, such as arthritis. Although pomegranate extract has antioxidant and anti-inflammatory actions in experiments on isolated tissues, it is not known whether ingestion of it can produce the same anti-inflammatory effects in living systems, either because the active compounds are not absorbed from the gut or because the levels of these compounds in the blood are not high enough.



Pomegranate extract, the equivalent of 175mls of pomegranate juice, was given to rabbits orally. The levels of antioxidants were measured in blood samples obtained after drinking the pomegranate extract and compared to blood samples collected before ingestion of pomegranate extract.



Plasma collected from rabbits following ingestion of pomegranate extract contained significantly higher levels of antioxidants than samples collected before ingestion of pomegranate extract; the extract also significantly reduced the activity of proteins that cause inflammation, specifically cyclooxygenase-2. It also reduced the production of pro-inflammatory compounds produced by cells isolated from cartilage.



The results of this study indicate the beneficial effects of pomegranate extract when ingested. According to Haqqi "the use of dietary nutrients or drugs based on them as an adjunct in the treatment of chronic inflammatory conditions may benefit patients". He adds that, "Current treatment with anti-inflammatory drugs can have serious side effects following long-term use. Further research is needed, however, especially on the absorption of orally ingested substances into the blood."







Notes:



1. Bioavailable Metabolites of Pomegranate (Punica granatum L) Fruit Extract Preferentially Inhibit COX2 Activity ex vivo and IL-1b-induced PGE2 Production in Articular Cartilage Chondrocytes in vitro.

Meenakshi Shukla, Kalpana Gupta, Zafar Rasheed, Khursheed A Khan and Tariq M Haqqi

Journal of Inflammation (in press)


Article available at the journal website: journal-inflammation/


All articles are available free of charge, according to BioMed Central's open access policy.



2. Tariq Haqqi is now with the Department of Pathology, Microbiology & Immunology, School of Medicine, at the University of South Carolina, Columbia.



3. Journal of Inflammation is an Open Access, peer-reviewed online journal on all aspects of research into inflammation.



4. BioMed Central (biomedcentral/) is an independent online publishing house committed to providing immediate access without charge to the peer-reviewed biological and medical research it publishes. This commitment is based on the view that open access to research is essential to the rapid and efficient communication of science.



Source: Charlotte Webber


BioMed Central

Topical Civamide Cream 0.075% Effectively Reduces Osteoarthritis Pain Without Harmful, Systemic Side Effects

Offers Promise for Those Failing on Oral Therapy or Who Are Concerned With the Side Effects of Oral Medications -



Winston Laboratories, Inc, The Pain Company(R), announced the results of a pivotal, Phase III study of civamide cream 0.075%
for osteoarthritis demonstrating that the topical therapy produced statistically significant improvement in all three
co-primary endpoints of the study. Significant decreases in pain, improvements in physical function, and increased subject
satisfaction were observed in osteoarthritis patients assigned to the active group. The double-blind, placebo-controlled,
parallel arm trial involved 695 patients with moderate-to-severe osteoarthritis pain that was not completely controlled by
taking oral pain medications.


"These data suggest that civamide cream holds promise as a safe and effective treatment for the signs and symptoms of
osteoarthritis," said Scott B. Phillips, M.D., Senior Vice President, Scientific Affairs, Winston Laboratories, Inc. "The
data also provide hope that civamide cream may help patients who are failing oral therapy or who won't take oral medications
because of their potential cardiovascular or gastrointestinal risks," he added.


The design and planning of the second pivotal Phase III trial of civamide cream 0.075% for osteoarthritis are currently
underway. Winston Laboratories, Inc. plans to begin the next trial later in 2005. A long-term safety study of civamide
cream 0.075% will be completed in the second quarter of 2005.


Winston Laboratories, Inc. is actively seeking a partner with sales and marketing strength to commercialize topical
civamide cream 0.075%.


About the Study


The 12-week, multi-center, randomized, double-blind study was designed to evaluate the efficacy and safety of civamide
cream 0.075% compared to a control cream containing a lower strength of civamide (0.01%) in the treatment of the signs and
symptoms of osteoarthritis. The three co-primary efficacy endpoints were improvement in the Pain Subscale and the Physical
Function Subscale of the Western Ontario McMaster Osteoarthritis Index (WOMAC), and the Subject Global Evaluation over the 12
weeks of the study.


The study enrolled men and women, 40 to 75 years of age, with osteoarthritis of the knee who at baseline were
experiencing significant pain (WOMAC Pain Subscale Score of greater than 9 out of a maximum of 20) while taking stable doses
of either an oral COX-2 inhibitor or a traditional non- steroidal anti-inflammatory drug (NSAID) for at least one month.
Patients were required to maintain the stable dose of their oral osteoarthritis medication for the duration of the trial.
Patients were evaluated for efficacy at days 21, 42, 63 and 84 (12 weeks) and for safety throughout the trial.


Civamide cream 0.075% was well tolerated. The principal adverse event was a transient, mostly mild-to-moderate burning
sensation at the application site. The burning sensation is related to civamide's mechanism of action, and decreased in
frequency over the first several weeks of treatment (affecting fewer than 9% of patients by week 3). Other adverse events
reported were application site warmth, infections, cough, nasopharyngitis, arthralgias and headache.















A pharmacokinetic study of civamide cream demonstrated that there was no detectable systemic absorption when applied
topically. The lack of systemic absorption suggests that civamide cream will not have the systemic side effects or drug
interactions often observed with other medications commonly used to treat osteoarthritis.


"We are pleased with these positive results for civamide cream 0.075%," noted Dr. Phillips. "The need for an effective
and safe topical osteoarthritis therapy is especially critical today, given that patients and providers currently are seeking
alternatives to oral COX-2 inhibitors and traditional NSAIDs," Dr. Phillips concluded.


About Civamide Cream 0.075%


Civamide (cis-8-methyl-N-vanillyl-6-nonenamide) is a patented, synthetically produced neuropeptide-active agent that
selectively depresses the activity of the type-C pain fibers. Civamide causes an initial release of the neuropeptides,
substance P (SP) and calcitonin-gene related peptide (CGRP). This release is believed to cause an initial burning sensation.
Pain transmission is then diminished by the subsequent depletion of SP and CGRP from the neuron, coupled with civamide's
interference with the synthesis and transport of neuropeptides along the neuron. Pain transmission pathways from affected
joints include neural branches to the skin overlying them, thus permitting this topical medication to affect the transmission
of pain from the joint to the brain.


Civamide is an investigational new drug and has not been approved by the U.S. Food and Drug Administration for any clinical
indication to date.


About Osteoarthritis


Osteoarthritis is the most common form of arthritis, affecting more than 20 million Americans and accounting for millions of
physician visits and significant disability. Current therapeutic options include oral medications, as well as intraarticular
medications and physical therapy.


About Winston Laboratories, Inc.


Winston Laboratories, Inc., The Pain Company(R) develops innovative prescription drugs for managing and alleviating pain.
Winston also actively discovers and patents new uses and delivery modalities for existing chemical entities with significant
potential for controlling pain. The Company's product candidates span a range of pain indications, including episodic
cluster headache, migraine headache, chronic daily headache, osteoarthritis, neuropathic pain, cancer pain and post-operative
pain. For further information, visit winstonelabs.


Contacts:


Scott B. Phillips, MD

Winston Laboratories




Eileen Masciale

EJM Public Relations



winstonelabs

Research Proves Tai Chi Benefits For Arthritis

A new study by The George Institute for International Health has found Tai Chi to have positive health benefits for musculoskeletal pain. The results of the first comprehensive analysis of Tai Chi suggest that it produces positive effects for improving pain and disability among arthritis sufferers.



The researchers are now embarking on a new trial to establish if similar benefits can be seen among people with chronic low back pain.



"This is the first robust evidence to support the beneficial effects of Tai Chi. Our study proves that Tai Chi relieves pain and disability among people with arthritis and shows a positive trend towards effects for overall physical health. We now want to see if these benefits are the same for people suffering from low back pain", said author Dr Chris Maher at The George Institute.



Musculoskeletal pain, such as that experienced by people with arthritis, places a severe burden on the patient and community and is recognised as an international health priority. Arthritis is the major cause of disability and chronic pain in Australia, with 3.85million Australians affected. Low back pain is the most prevalent and costly musculoskeletal condition in Australia, estimated to cost up to $1billion per annum with indirect costs exceeding $8billion.



"This research should reassure people with musculoskeletal conditions such as arthritis to seek exercise to relieve the pain. The fact that Tai Chi is inexpensive, convenient, enjoyable and conveys other psychological and social benefits supports the use this type of intervention for pain conditions", added Ms Amanda Hall, The George Institute.



Tai Chi is a form of exercise that is regularly practiced in China for general health purposes and has gained increasing popularity in North America and Australia and thus a growing body of research aimed at investigating its health benefits has emerged.



Tai Chi is a versatile activity that can be easily incorporated into people's daily activities. Usually preformed in a group, Tai Chi can also be practiced individually, which differs from traditional exercise therapy approaches in clinic.


Notes:


Abstract.



The George Institute for International Health is an internationally-recognised health research organisation, undertaking high impact research across a broad health landscape. It is a leader in the clinical trials, health policy and capacity-building areas. The Institute has a global network of top medical experts in a range of research fields as well as expertise in research design, project management and data and statistical analysis. With a respected voice among global policy makers, The Institute has attracted significant funding support from governments, philanthropic organisations and corporations. George Institute research is regularly published in the top tier of academic journals internationally.



References:



* Arthritis Australia

* Australian Institute of Health and Welfare. Australia's health 2000: the seventh biennial health report of the Australian Institute of Health and Welfare. 7th ed. Canberra: AIHW, 2000.

* Walker B, Muller R, Grant W. Low back pain in Australian adults: the economic burden. Asia Pacific Journal of Public Health 2003;15(2):79-87.



Source:

Emma Orpilla

Research Australia

Hormone Replacement In Joint Fluid Has Potential Regenerative Effect

German researchers determined that concentrations of the sex hormones, testosterone in men and estrogen in women, may have a positive effect on the regenerative potential of cartilage tissue. The study suggests hormone replacement in the joint fluid of men and women might be beneficial in treating late stages of human osteoarthritis (OA) by regenerating damaged tissue. Details of this evidence-based study appear in the April issue of Arthritis & Rheumatism, a journal published by Wiley-Blackwell on behalf of the American College of Rheumatology.



Free moving (diarthrodial) joints, such as the knee and hip, produce smooth and painless limb movement when there is adequate transmission of forces between the bones and joint (articular) cartilage. Disturbances in joint architecture due to trauma, abnormal load, endocrine diseases (diabetes, hypothyroidism) or inflammatory conditions may result in OA. Worldwide estimates say 9.6% of men and 18% of women 60 years or older have OA symptoms and the World Health Organization (WHO) projects that by 2020, OA will be the fourth leading cause of disability.



Nicolai Miosge, M.D., Ph.D., and colleagues from the August University in Goettingen, Germany examined the regenerative potential of chondrogenic progenitor cells (CPCs) that are present in arthritic tissue during the late stages of OA. The research team speculated that these CPCs might be influenced by sex steroids, and therefore hormone replacement therapy directed to the joint fluid could be beneficial in restoring damaged tissue. Tissue samples from 372 patients who underwent total knee replacement were analyzed. The mean age was 71 years of age for men and 72 years for women, with women representing 64.25% of participants.



Estrogens are known to influence bone metabolism and researchers found that 17??-estradiol (E2), which increases calcium deposition in both sexes, was present in the joint fluid of study participants. CPCs positive for estrogen receptors (ER?± and ER??) as well as androgen receptors were present in the OA tissue as well. Both estrogen and testosterone influenced the expression of all 3 receptor genes and the CPCs by regulating gene expression.



Researchers found late-stage OA cartilage populated with elongated cells that were not present in healthy connective tissue. Upon investigation of the elongated cells, the team identified a unique progenitor cell population (CPCs). "We were able to isolate CPCs in 95.48% of female patients and 96.97% of male patients, making these cells a good target for future therapeutic intervention for a very large number of OA patients," Dr. Miosge said. "Hormone replacement therapy in joint fluid may help mitigate the effects of OA and further investigation is needed," concluded Dr. Miosge.



Article: "Sex Differences of Chondrogenic Progenitor Cells in Late Stages of Osteoarthritis." Sebastian Koelling and Nicolai Miosge. Arthritis & Rheumatism; Published Online: March 30, 2010 (DOI: 10.1002/art.27311); Print Issue Date: April 2010.



Source:

Dawn Peters

Wiley-Blackwell

Nearly Half Of Rheumatoid Arthritis Sufferers Feel Early Treatment Would Have Given Them More Independence

A UK survey of 575 rheumatoid arthritis sufferers highlights the importance of maintaining independence and the significant impact that early diagnosis and treatment can have. Over 94% of those surveyed claimed that their independence was compromised in some way, with over 60% saying it was compromised significantly. With earlier treatment of their disease, nearly half of the respondents felt that they would have been more independent today, making it vital that people are aware of the significance of early intervention.



Ailsa Bosworth, Chief Executive of NRAS said, "The response to this survey highlights what we already know to be true, that early treatment can make a big difference on the impact that rheumatoid arthritis can have on a person's life. Maintaining independence is so important, not only in terms of sustained quality of life and the ability to work, but also to keep personal hopes and dreams for the future alive. This Independence Day, we are encouraging people who are experiencing signs of rheumatoid arthritis, or who do not feel that their disease is currently well controlled, to seek advice from a healthcare professional as early as possible to help ensure that their independence and optimum quality of life is maintained."



In the survey, developed by Wyeth Pharmaceuticals and supported by NRAS, simple activities which are normally taken for granted are shown to be significantly affected by rheumatoid arthritis. Around 36% of those surveyed have difficulties picking up a child or grandchild, 50% have difficulties simply going to the shops and a further 68% struggle to look after their garden. In addition 60% were significantly compromised in their ability to do their job. It has been estimated that the direct and indirect cost of the condition in the UK is up to ??4.75 billion a year, largely due to lost productivity.1



Research has shown that there is much potential to improve outcomes for people with rheumatoid arthritis through earlier identification and specialist treatment2; early effective treatment for rheumatoid arthritis can maximise the chances of slowing down disease progression. This minimises joint damage and permanent disability and has a very significant impact on independence and consequently a person's overall wellbeing and quality of life.3



Rheumatoid arthritis is a chronic, progressive and disabling autoimmune condition that affects around 400,000 people in the UK with about 12,000 new cases diagnosed each year.1 It can cause stiffness, swelling and limitation in the motion and function of multiple joints. It is two to three times more common in women than men1 and can start at any age, usually between 40 and 70 years leading to irreversible joint destruction.4 Common symptoms of rheumatoid arthritis include joint pain, joint swelling, stiffness (often in the morning) and tiredness. It is a painful and distressing condition that can have a substantial impact on independence, however there is much potential to improve outcomes for people with rheumatoid arthritis through earlier identification and specialist treatment.2




References


1. NICE Clinical Guideline 79. Rheumatoid Arthritis: The Management of Rheumatoid Arthritis in Adults. February 2009.


2. The King's Fund Report for the Rheumatology Futures Group. Perceptions of patients and professionals on rheumatoid arthritis care. Available Online: here. Last Accessed June 2009.


3. Sokka R. Work Disability in Early Rheumatoid Arthritis. Clinical and Experimental Rheumatology 2003:21 (suppl 31):S71-S74.


4. Lee DM, Weinblatt ME. Rheumatoid Arthritis. Lancet 2001; 358: 903-911.


Source
Wyeth Pharmaceuticals

Current And Emerging Drugs Have No Advantage Over Enbrel In Inhibiting/Slowing The Progression Of Rheumatoid Arthritis

Decision Resources, one
of the world's leading research and advisory firms focusing on
pharmaceutical and healthcare issues, finds that a drug's effect on
inhibiting/slowing the progression of structural damage and reducing the
signs and symptoms of rheumatoid arthritis during the first year of
treatment are the attributes that most influence surveyed rheumatologists'
prescribing decisions in the treatment of the disease. Clinical data and
expert opinion shows that current and emerging therapies have no advantage
in these attributes over the market sales leader, Amgen/Wyeth/Takeda's
Enbrel.


The new report entitled Rheumatoid Arthritis: Competitive, Crowded
Market Sets the Bar High for Novel Agents finds that, through 2016, there
are no therapies in development that will displace Enbrel as the clinical
gold standard treatment for rheumatoid arthritis. While some therapies in
development for the disease hold promise, most have efficacy, safety and
tolerability, and/or delivery features that are inferior when compared with
Enbrel.



The overall efficacy of emerging therapies such as
Centocor/Schering-Plough/Mitsubishi Tanabe/Janssen's golimumab and Biogen
Idec/Genentech/Roche's ocrelizumab is comparable to that of Enbrel, while
the overall safety and tolerability for emerging therapies that include
ocrelizumab and UCB's Cimzia are also comparable to that of Enbrel.
However, the currently available clinical data for golimumab, ocrelizumab
and Cimzia is not as robust or extensive as those available for Enbrel.



"While emerging therapies such as golimumab and Cimzia offer superior
delivery to that of Enbrel due to improved dosing frequencies, these
agents' overall efficacy, safety and tolerability, respectively, are
inferior to those of Enbrel-and efficacy, safety and tolerability are
weighted more heavily by surveyed rheumatologists as key drivers of
prescribing decisions," said Cindy Mundy, Ph.D., director at Decision
Resources. "As a result, the improvements in dosing frequency that
golimumab and Cimzia offer over Enbrel are not sufficient to propel either
agent to the position of future gold standard."



About the Report



Rheumatoid Arthritis: Competitive, Crowded Market Sets the Bar High for
Novel Agents is a DecisionBase 2008 report from Decision Resources.
DecisionBase 2008 combines market forecasts with clinical and commercial
end points to assess market share projections in 35 indications. These
outputs are driven by quantitative and qualitative primary research.
DecisionBase 2008 provides detailed market share, patient share, and
price-per-day projections for emerging drugs in development. The market
share projections are based on prescriber surveys that compare physicians'
expectations of a potential target product profile with an emerging product
profile of the leading drugs in development.



The report can be purchased by contacting Decision Resources. Members
of the media may request an interview with an analyst.



About Decision Resources



Decision Resources, Inc. (decisionresources) is a world
leader in market research publications, advisory services, and consulting
designed to help clients shape strategy, allocate resources, and master
their chosen markets. Decision Resources is a Decision Resources, Inc.
company.



All company, brand, or product names contained in this document may be
trademarks or registered trademarks of their respective holders.


Decision Resources, Inc.

decisionresources


View drug information on Cimzia; Enbrel.

AMA Welcomes New Body To Combat Rheumatic Heart Disease, Australia

AMA Vice President and Chair of the AMA Taskforce on Indigenous Health, Dr Steve Hambleton, said today that RHDAustralia is an important first step towards eradicating rheumatic heart disease among Indigenous people.


The Government has provided RHDAustralia with $2.5 million over four years to combat rheumatic heart disease, which is a major killer of Aboriginal and Torres Strait Islander people.


"For several years, the AMA has been calling for a coordinated national effort to eradicate rheumatic heart disease among Indigenous people," Dr Hambleton said.


"Acute rheumatic fever and rheumatic heart disease can be prevented if the right screening, management and notification processes - and follow up - are put in place.


"Now that this initiative has commenced with RHDAustralia, we would like the Government to continue to build on the momentum by implementing the $11.2 million Rheumatic Fever Strategy that was promised prior to the 2007 election.


"The AMA believes it is essential that RHDAustralia keeps all the relevant stakeholders involved and informed, especially when it comes to the development of a national register and refinement of best practice guidelines.


"Stakeholders include Indigenous communities, health services, individual doctors, and their representative organisations," Dr Hambleton said.


Source
Australian Medical Association

Rheumatoid Arthritis Impacts Millions Of Americans But Remains Severely Underfunded

Rheumatoid arthritis (RA) affects 2.1
million Americans and despite many advances in the understanding of the
disease, funds for research remain limited and both the cause and a cure
are still unknown. The American College of Rheumatology Research and
Education Foundation (ACR REF) is working to accelerate RA research and
expand financial support of this disease by launching the Within Our Reach:
Finding a Cure for Rheumatoid Arthritis campaign. The new program is
designed to raise unprecedented funds to search for a cure.



RA is the most common form of inflammatory arthritis and costs society
more than $80 billion each year. The disease affects more than one in every
200 Americans. However, research funding for RA averages as little as
$25.90 per patient and remains significantly low compared to other chronic
diseases that affect far fewer people like lupus, diabetes and multiple
sclerosis, which average $330.00 per patient. Despite the lack of funding,
research has led to more effective and aggressive, treatments as well as a
better understanding of how to manage the disease.



"Therapy for patients with RA has improved dramatically, and we also
have learned that early diagnosis is essential," said Dr. James R. O'Dell,
president of the REF. "While there is no cure, patients who receive
treatment early feel better and are more likely to lead an active life.
Painful symptoms including inflammation and joint damage can be minimized
with early treatment and further research will continue to better patients'
lives and get us closer to a cure."



Rheumatoid Arthritis Symptoms and Diagnosis



RA is a chronic, autoimmune disease that develops because certain cells
of the immune system malfunction and attack healthy joints. It is far more
common in women than many expect. Approximately 1 to 3 percent of women may
develop RA in their lifetime, which is three times more common in women as
in men. While symptoms most often begin between the fourth and sixth
decades of life, RA can develop at any age.



Pain, stiffness, swelling, and limitation in the motion and function of
multiple joints are the most common symptoms. Though joints are the
principal body parts affected by RA, inflammation can develop in other
organs as well. Additional warning signs also include:


-- Loss of energy


-- Low-grade fevers


-- Loss of appetite


-- Dry eyes and mouth from an associated condition known as Sjogren's
syndrome















-- Firm lumps called rheumatoid nodules beneath the skin in areas such as
the elbow and hands



RA can be difficult to diagnose because it may begin gradually and many
diseases behave in a manner similar to RA. Patients suspected of having RA
should be evaluated by a rheumatologist, a physician with the necessary
skill and experience to reach a precise diagnosis and develop the most
appropriate treatment plan.



Patients can visit rheumatology/directory to find a
rheumatologist in their area.



About Within Our Reach: Finding a Cure for Rheumatoid Arthritis
Campaign



Within Our Reach is a national, multi-year fundraising campaign with a
goal to raise $30 million towards accelerating innovative research focused
specifically on rheumatoid arthritis. It is the largest private fundraising
campaign in the REF's history, which will tap a diverse donor base,
supporting innovative research to learn more about the causes of RA and,
ultimately, to find a cure. Since November, the campaign has received
tremendous support from the pharmaceutical industry, biotech companies,
physicians and patients.



"Today, more funding needs to be directed towards the kind of RA
research that goes beyond treatment only - the kind of RA research that
seeks to find a cure through better understanding of the causes of and
preventions for this devastating disease," added Dr. O'Dell. "With the
guidance of ACR Research and Education Foundation, Within Our Reach will
allow more of this type of research to be conducted and together we can
work to find a cure."



To learn more about rheumatoid arthritis and Within Our Reach, please
visit WithinOurReach.



About the ACR Research and Education Foundation



The ACR Research and Education Foundation was established in 1985 as a
501(c)(3) with a mission to improve patients' lives through support of
research and training that advances the prevention, treatment and cure of
rheumatic diseases. Since its founding, the REF has promoted and advanced
the field of rheumatology by funding research, training and education
opportunities for clinicians, students, health professionals, researchers
and academic institutions. On average, 90 cents of every dollar donated to
the REF is used to fund its extensive award and grant program.


American College of Rheumatology Research and Education Foundation

WithinOurReach

MabThera(R) Virtual Clinic Gives Rheumatologists Real-Life Patient Insight

The MabThera Virtual Clinic - an exciting web-based resource - is a new initiative that provides physicians with key insights into the use of MabThera (rituximab), the first and only selective B cell therapy for the treatment of rheumatoid arthritis (RA).


Using anonymised real-life cases of RA patients from around the world, the Virtual Clinic details the experiences of practicing rheumatologists prescribing MabThera. It features an overview of patients' medical history and their treatment strategies. The cases demonstrate the clinical aspects of using MabThera, illustrating the efficacy, safety and duration of response with each course of treatment, helping physicians to identify those patients that would benefit the most from treatment.


The Virtual Clinic is an interactive resource tool which allows physicians to access cases according to specific clinical dilemmas and to view how MabThera is being used in clinical practice. It gives physicians an opportunity to share and learn from experience made by their colleagues.



The MabThera Virtual Clinic forms part of Roche's commitment to improving the lives of people living with RA, one of the most common forms of autoimmune disease which affects over 21 million people worldwide. [1]


The MabThera Virtual Clinic is available at MabThera-RA.


References

[1] United Nations World Population Database, 2004 revision. use.un/unpp

Although Women Live Longer, They Do Not Live Better, Largely Because Of Obesity And Arthritis

Obesity and arthritis that take root during early and middle age significantly contribute to women's decreased quality of life during their senior years, according to researchers at Duke University Medical Center.



In a study that included 5,888 people over 65, women suffered up to two and a half times more disabilities than men of the same age.



Higher rates of obesity and arthritis among these women explained up to 48 percent of the gender gap in disability - above all other common chronic health conditions.



"While women tend to live longer than men, this study shows that they are at greater risk of living with disability and much of the excess disability is attributable to higher rates of obesity and arthritis," said Heather Whitson, M.D., assistant professor of medicine and lead investigator of the study presented at the Annual Scientific Meeting of the American Geriatrics Society. "This is important because it suggests that women's tendency to pack on extra pounds in their child-bearing and peri-menopausal years translates into loss of independence in their old age."



Researchers said the study is the first to isolate the impact of specific chronic health conditions on the difference in disability rates between older men and women. While many people are studying how chronic conditions affect mortality, the investigators were surprised to see the extent to which these conditions explained the gender difference in disability.



"The reason for this discrepancy in disability has not been well understood but we found that chronic health conditions that women experience in greater numbers than men may explain part of that gap," said Harvey Jay Cohen, M.D., the study's senior author, chair of the Department of Medicine and director of Duke's Center for the Study of Aging and Human Development.



"Women have a natural tendency to gain more weight than men over the lifespan, but may be more motivated to maintain a healthy weight if they realize that those extra pounds make it more likely that they will be disabled in later years - potentially becoming a burden to their children or requiring a nursing home," Whitson said.



The current study is an analysis of the Cardiovascular Health Study which asked participants about their ability to conduct common activities of daily living, such as grooming, eating, getting dressed, managing money and upper and lower body movement, including reaching, grasping, walking and climbing stairs.



The Duke team said the study also draws attention to two concerning health trends that could worsen the average quality of life for women in the future. First, as the rate of obesity continues to rise, the rates of disability in older adults are expected to increase. To the extent that women are more likely than men to develop obesity, the obesity epidemic will have its greatest impact on older women's quality of life.
















Second, the investigators note that women are gaining equality with men on cardiovascular disease, stroke and emphysema, which had previously been less common among women. Rates of cardiovascular disease are not improving as quickly among women as they are among men and smoking-related disease is becoming more common in women. If the occurrence of these conditions becomes more comparable between men and women, the result would be an even wider gap in disability rates.



"The findings of our study are more troubling when you consider the increasing rates of obesity among women and the higher rates of other conditions that are currently over-represented among men," Cohen said. "We need to help women make better decisions earlier in life."



In addition to obesity and arthritis, the study found the women were more likely than men to experience fractures, vision problems and bronchitis. Men were more likely to have emphysema, coronary heart disease, congestive heart failure, stroke, diabetes and hearing problems.



Researchers say that the next step is to determine whether older women who have been disabled by obesity or arthritis regain function if they undergo treatment to help them achieve a healthy weight or to control their arthritis pain. If not, then it becomes even more important to focus efforts on preventing obesity and arthritis in younger populations.



Study co-authors include Drs. Lawrence L. Landerman, Anne B Newman, Linda P. Fried and Carl F. Pieper.



The research was supported by National Institutes of Health, University of Pittsburgh Claude D. Pepper Older Americans Independence Center, John A. Hartford Center for Excellence, Duke Claude D. Pepper Older American Independence Center, a John A. Hartford Foundation Geriatrics Outcomes Research Award and Paul B. Beeson Career Development Award.



Source:
Melissa Schwarting


Duke University Medical Center

Osteoarthritis Increases Aggregate Health Care Expenditures By $186 Billion Annually

Osteoarthritis (OA), a highly prevalent disease, raised aggregate annual medical care expenditures in the U.S. by $185.5 billion according to researchers from Stony Brook University. Insurers footed $149.4 billion of the total medical spend and out-of-pocket (OOP) expenditures were $36.1 billion (2007 dollars). Results of the cost analysis study are published in the December issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology.



The Centers for Disease Control and Prevention (CDC) estimate 27 million Americans suffer from OA with more women than men affected by the disease. Forecasts indicate that by the year 2030, 25% of the adult U.S. population, or nearly 67 million people, will have physician-diagnosed arthritis. OA is a major debilitating disease causing gradual loss of cartilage, primarily affecting the knees, hips, hands, feet, and spine.



John Rizzo, Ph.D., and colleagues used data from the 1996-2005 Medical Expenditure Panel Survey (MEPS) to determine the overall annual expected medical care expenditures for OA in the U.S. The sample included 84,647 women and 70,590 men aged 18 years and older who had health insurance. Expenditures for physician, hospital, and outpatient services, as well expenditures for drugs, diagnostic testing, and related medical services were included. Healthcare expenses were expressed in 2007 dollars using the Medical Care Component of the Consumer Price Index.



Researchers, using multivariable regression models, determined annual insurer healthcare expenditures were $4,833 for women and $4,036 for men. Out-of-pocket expenses were also higher in women than men, at $1,379 and $694, respectively. "Understanding the economic costs of OA is important for payors, providers, patients, and other stakeholders," said. Rizzo. "Our study clearly reflects the significant impact of OA on U.S. healthcare spending."



Further analysis provided aggregate data based upon arthritis prevalence rates reported in a study by Helmick et al., and also published in Arthritis and Rheumatism (2008). The current study determined that OA increased insurer costs by $149.4 billion and OOP expenditures by 36.1 billion annually, for an aggregate increase of $185.5 billion per year. According to the authors women accounted for more of the expenditures ($118 billion) than men ($67.5 billion), reflecting the higher occurrence of the disease among women.



In recent years the prevalence of OA has risen rapidly and this trend is expected to continue. Increased awareness and better screening to identify patients with OA may help to delay disease progression and its debilitating effects which could mitigate costs to insurers and patients. "Our results suggest that patients with OA may benefit from greater efforts to promote exercise, proper medication use, and appropriate surgical treatments for the disease," concluded Dr. Rizzo.



Article: "Insurer and Out-of-Pocket Costs of Osteoarthritis in the US." Harry Kotlarz, Candace L. Gunnarsson, Hai Fang, and John A. Rizzo. Arthritis & Rheumatism; Published Online: November 30, 2009 (DOI 10.1002/art.24984); Print Issue Date: December 2009.



Source: Dawn Peters


Wiley-Blackwell

New Study Re-evaluates Cardiovascular Risks Of Non-steroidal Anti-inflammatory Drugs (NSAIDS)

High doses of some traditional non-steroidal anti-inflammatory drugs (NSAIDS) are associated with similar cardiovascular risks as the new generation of anti-inflammatory drugs known as COX 2 inhibitors (like Vioxx ®), finds a study in this week's BMJ.


Researchers from the UK and Italy performed a combined analysis (known as a "meta-analysis") of all the available randomised trials that compared a COX 2 inhibitor with placebo, or a COX 2 inhibitor with a traditional NSAID, and had recorded serious cardiovascular events. By including data from 138 trials among 140,000 patients, this meta-analysis provides a much more reliable estimate of the cardiovascular risks of these drugs, since individual trials were too small to study this question.


The study showed, as expected, that, COX 2 inhibitors were associated with an increased risk of vascular events, mainly heart attack. Unfortunately, there were insufficient data to reliably assess whether these risks were dose dependent, or whether the risks might differ among aspirin and non-aspirin users.


But the study also showed that high doses of two of the NSAIDs studied, diclofenac and ibuprofen, were associated with a similar increase in the risk of vascular events to COX 2 inhibitors, although the risks of high doses of another NSAID, naproxen, were smaller.


However, the average increased risk of vascular events was modest among the people studied in the trials: For every 1,000 people taking an NSAID or COX 2 inhibitor, around three extra people per year would have a vascular event, most likely a heart attack.


The authors conclude that very large randomised trials are needed to identify which anti-inflammatory drug regimens minimise serious cardiovascular and gastrointestinal problems.


An accompanying editorial discusses other options for treating chronic pain and suggests that doctors work with their patients to choose the best solutions for them.


Do cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials; BMJ Volume 332, pp 1302-5


Emma Dickinson

edickinsonbmj

BMJ-British Medical Journal

bmj


View drug information on Vioxx.

Othopaedists Say Biomarker Could Make Diagnosing Knee Injury Easier, Less Costly

A recently discovered biomarker could help doctors diagnose a common type of knee injury, according to a new study.



A team of researchers led by Gaetano Scuderi, MD, clinical assistant professor of orthopaedic surgery at Stanford University School of Medicine and an orthopaedic surgeon at Stanford Hospital & Clinics, has confirmed that a particular protein complex appears in patients with painful meniscal tears. The finding, to be published Feb. 16 in /i>The Journal of Bone and Joint Surgery, could be used to prevent needless surgery and to save billions of dollars in medical-imaging costs.



The menisci are two crescent-shaped pieces of cartilage in each knee joint. Contact sports, such as football, as well as sports that involve lot of pivoting, such as basketball and tennis, increase the risk of the cartilage tearing. It is also prone to tear as a result of natural degeneration, meaning older people are at increased risk. Meniscal tears are painful and usually accompanied by swelling and stiffness. Sometimes the knee joint feels as though it is locked in place.



Patients are generally advised to elevate and apply ice to the knee, as well as to take a break from physical activity that could aggravate the injury. These measures might not be enough, however, so patients can undergo a minimally invasive procedure, arthroscopic surgery, to trim away or repair the meniscus.



But identifying whether a patient's knee pain stems from a meniscal tear, as opposed to joint arthritis or another type of leg injury, is difficult. For example, in an older patient, magnetic-resonance imaging might reveal an abnormal-looking meniscus that doctors mistake as evidence of a painful tear, even though it is just due to natural degeneration from lots of wear over the years. For such a patient, who is perhaps really suffering from joint arthritis, meniscal surgery would offer no relief.



Knee pain also can stem from other parts of the body. For example, a young athlete who complains of symptoms similar to those of a torn meniscus may undergo a costly MRI that reveals no cartilage abnormalities. In reality, an injured hip ligament could be causing the knee to hurt. "It's like someone with heart disease feeling pain in his left shoulder," Scuderi said.



In the study, Scuderi and his co-authors found that the biomarker appeared in the knee fluid of 30 patients who had suffered a painful meniscal tear. It was not present in the knees of 10 asymptomatic patients. The biomarker, a fibronectin-aggrecan complex, holds out the promise of allowing orthopaedists to quickly and accurately diagnose whether the source of a patient's discomfort is a meniscal tear, as opposed to another type of injury or abnormality, simply by taking a sample of knee fluid. It could thus obviate the need for expensive medical scans and help to prevent surgery that does not address the true cause of a patient's pain.



"The challenge is not identifying molecular markers of cartilage degeneration, dozens of which are now known," said co-author Raymond Golish, MD, PhD, who recently completed a fellowship in spine surgery at Stanford. "The difficulty is in finding markers that correlate with painful injuries, as opposed to age-related degeneration that is painless. This study is a big step in that direction."



Scuderi and his colleagues undertook the prospective study to validate their findings from an earlier study in which they first noted the presence of the protein complex in patients with torn menisci and knee pain. (Those results were published in the July 2010 issue of Clinical Biochemistry.)



The researchers are now running experiments to confirm that the biomarker does not show up in other types of knee injuries, such as ACL tears unaccompanied by meniscal tears. They also are studying whether the protein complex, which is implicated in knee inflammation, could serve as a therapeutic target. "We could envision several things, such as blocking the fibronectin and aggrecan protein fragments from coming together to form a complex, or interfering with the activation of white blood cells at the site," Scuderi said.



Notes:



The research was supported by Cytonics Inc., a Florida-based company founded by Scuderi in 2006 to pursue possible clinical applications of the fibronectin-aggrecan complex. Researchers from the Jupiter Medical Center, the New York University Hospital for Joint Diseases, the University of Pittsburgh and Cytonics Inc. were also co-authors of the study. Stanford's Department of Orthopaedic Surgery also supported this work.



Source:

John Sanford

Stanford University Medical Center

Psoriasis: Effects Don't Always Stop With The Skin

Psoriasis, a chronic disease that causes red, raised patches of skin, is increasingly seen as a systemic disease with links to arthritis and cardiovascular disease. The December issue of Mayo Clinic Women's HealthSource provides an overview of this sometimes embarrassing condition, what's known about it and how it's treated. Highlights of the overview include:


-- Symptoms: Patches of thick, red skin covered with silvery, flaky scales commonly appear on the elbows and knees, but can appear anywhere on the body. They result from skin cells on overdrive, reproducing much faster than normal. Doctors aren't sure why this overproduction occurs, although genetic and environmental factors likely play roles. Psoriasis symptoms come and go and flare in response to triggers that can include infections, some medications, alcohol, smoking, stress, sunburn, skin irritation or injury.


-- A systemic illness: Doctors are finding that psoriasis is more than a skin disorder. About one in four people with psoriasis develop a form of arthritis called psoriatic arthritis that can cause pain, stiffness and swelling in the joints. Studies have shown that people with psoriasis face a higher risk of heart attack, stroke and other cardiovascular problems. The underlying link may be chronic inflammation, which plays a role in psoriasis and heart disease.


-- Treatment: While psoriasis can't be cured, a variety of topical and systemic treatment options can help control the condition. For mild-to-moderate psoriasis, topical treatments often are effective. Options include corticosteroids or retinoids to reduce inflammation; vitamin D analogs to slow skin growth; and tar, to reduce scaling, itching and inflammation. Calcineurin inhibitors (tacrolimus and pimecrolimus) can help reduce inflammation and skin cell buildup.


In addition, ultraviolet light slows the rapid growth of skin cells. Ultraviolet light therapy may be used alone or in combination with other treatments. Several systemic medications are used for severe forms of psoriasis, though these options pose the risk of serious side effects.


-- Self-help measures: Home-care measures can help prevent or manage symptoms. A daily bath removes scales and calms inflamed skin. Adding bath oil, colloidal oatmeal, Epsom salts or Dead Sea salts can offer additional relief. After bathing, applying a thick moisturizing cream or ointment, such as petroleum jelly, can be helpful. During cold, dry weather, it's beneficial to apply moisturizer several times a day. Short sessions in sunlight three or more times a week can improve psoriasis, as can avoiding known triggers.


Source: Mayo Clinic

The impact of genetic variations on the treatment of early rheumatoid arthritis

Characterized by inflammation in the connective tissues of the joints, rheumatoid arthritis (RA) can be a painful, crippling autoimmune disease. Traditionally, patients have been treated with disease-modifying antirheumatic drugs, or DMARDs, such as methotrexate (MTX). Several new therapies, however, focus on blocking tumor necrosis factor, or TNF, one of the body's chemical messengers with a role in regulating the inflammation. Although MTX and TNF blockers work well in the treatment of RA, they vary widely with regard to effectiveness and side effects, and there are currently no markers to predict response to particular drugs.


In a recent study, published in the September 2004 issue of Arthritis & Rheumatism, researchers set out to examine whether specific genetic variations could predict the response to treatment of early RA. Led by S. Louis Bridges, Jr., M.D., Ph.D. of the University of Alabama at Birmingham and Lindsey A. Criswell, M.D., M.P.H. of the University of California, San Francisco, the group analyzed genetic and clinical data on 457 patients in the early stages of RA who participated in a clinical trial comparing weekly methotrexate, 10 milligrams twice weekly of the anti-TNF drug etanercept, and 25 milligrams of etanercept twice weekly (the currently approved dose for RA). The results of this clinical trial have been previously published (Bathon et al. New Engl J Med 343:1586-1593, 2000).


Researchers examined patients for a particular genetic marker in the HLA region associated with susceptibility to RA (the so-called shared epitope), as well as genetic variants in the TNF gene region. Results of genetic testing were then correlated with treatment responses. Among patients treated with standard-dose etanercept, those with two copies of the shared epitope were four times more likely to achieve 50 percent improvement in disease activity (according to the criteria of the American College of Rheumatology) at 12 months than were patients with one copy or no copies of the shared epitope. Furthermore, patients with particular HLA genes in addition to particular genetic variations in the TNF gene region were found to have better responses to treatment, regardless of which drug was used.



"Results of the current study suggest that, at least for RA patients with early active disease, genetic variations in the HLA and TNF gene regions are associated with response to treatment," Dr. Criswell concludes. "Additional work is required to confirm these results," Dr. Bridges adds, acknowledging the complexity of genetic involvement in RA, "as well as to extend these observations to patients of other ethnicities, and more precisely define the individual genes and haplotypes responsible for these associations."


Article: "The Influence of Genetic Variation in the HLA-DRB1 and LTA-TNF Regions on the Response to Treatment of Early Rheumatoid Arthritis With Methotrexate or Etanercept," Lindsey A. Criswell, Raymond F. Lum, Kevin N. Turner, Blanche Woehl, Yuanqing Zhu, Jinyi Wang, Hemant K. Tiwari, Jeffrey C. Edberg, Robert P. Kimberly, Larry W. Moreland, Michael F. Seldin, and S. Louis Bridges, Jr., Arthritis & Rheumatism, September 2004, 50:9; pp. 2750-2756.


Contact: Amy Molnar

amolnarwiley

201-748-8844

John Wiley & Sons, Inc.

Human Articular Cartilage Repaired With Amniotic Membrane

"The objective was to evaluate the utility of cryo-preserved human amniotic membrane (HAM) as a support for repairing human articular cartilage injuries, which have a very limited capacity for self-healing", Francisco J. Blanco, lead author of the study and a researcher at the Institute of Biomedical Research of La Coruna (INIBIC), tells SINC.



The results, which have been published in the journal Cell and Tissue Banking, show that cryo-preserved HAM is useful as a scaffold for growing human chondrocytes in cell therapy and for repairing human cartilage injuries. "It provides a more regular surface and fills in the cavities and fissures", explains Blanco.



The authors cultivated the chondrocytes (cells that form part of the cartilaginous tissue), isolated from human articular cartilage, on the amniotic membrane over a period of three and four weeks. The amniotic membranes were used to develop 44 repair models of arthritic human articular cartilage in vitro, which was assessed between four and 16 weeks later.



The HAM also bonds well with the native cartilage. "In some models, we could not differentiate between where the native tissue stopped and the neo-synthesised tissue began", says the expert. This tissue had a fibrous appearance and high cellular density (cellularity), which in some cases was greater than that of the actual native cartilage.



The use of differentiated chondrocytes is a useful therapeutic option for repairing articular cartilage injuries. However, there are limitations to implanting these cells, since many patients will be ruled out due to their lack of healthy chondrocytes, and this technique also causes additional damage to the joint.



"Transplanting chondrocytes cultivated on different natural or synthetic 'scaffolds' is used today in cell tissue engineering. The HAM has sparked great interest over recent years, above all in the field of regenerative medicine", concludes Blanco.



Clinical solutions to osteoarthritis



Osteoarthritis (OA) is a major articular pathology that is characterised by alteration of the cartilage and the bone that supports it, the subchondral bone. As the current pharmacological and surgical treatments have only palliative effects, cell therapy is a new clinical approach for repairing damaged or destroyed tissues.



HAM has many clinical advantages as a support - it is an anti-microbial, anti-angiogenic, anti-tumour tissue, which reduces inflammation and pain and improves scarring. In addition, the amnios of the HAM has no immune response, meaning there are no risks associated with transplanting it, and it contains many of the components of natural cartilage.



References: Silvia D?­az-Prado; M?? Esther Rendal-V??zquez; Emma Mui?±os-L??pez; Tamara Hermida-G??mez; Margarita Rodr?­guez-Cabarcos; Isaac Fuentes-Boquete; Francisco J. de Toro; Francisco J. Blanco. "Potential use of the human amniotic membrane as a scaffold in human articular cartilage repair". Cell Tissue Bank (2010) 11:183-195 DOI 10.1007/s10561-009-9144-1.



Source:

SINC


FECYT - Spanish Foundation for Science and Technology

Renowned Bone Health Experts To Lead Interactive Sessions At The World Congress On Osteoporosis 2010

The International Osteoporosis Foundation (IOF) and the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) will hold a joint global congress, IOF WCO- ECCEO10, in Florence, Italy from May 5-8, 2010.



Complete programme information, online registration and abstract submission will be available on iofwco-ecceo10 .



IOF WCO-ECCEO10 will be an excellent forum for interaction and the exchange of ideas among researchers and clinicians as well as specialists from allied health fields. It will offer an overview of the most recent developments and cutting-edge research in the pathophysiology, diagnosis, prevention and treatment of osteoporosis and osteoarthritis, as well as policy related issues such as health economics.



Offering a broad global perspective, the scientific programme will provide a mix of stimulating plenary lectures on 'hot' topics in the field and more clinically-oriented meet-the-expert sessions led by world experts. There will also be poster presentations, late breaking news, satellite symposia, and a large exhibition area.



Meet-the-expert sessions to be led by world experts:



Each day specialists will lead exchanges on 20 key topics. Small groups, on a first come first served basis, will be encouraged to not only ask questions but to also provide feedback about their own experiences. The following topics and speakers are scheduled:
Assessing bone strength beyond DXA, C. Gl??er (Germany)


Optimal dose of vitamin D, B. Dawson-Hughes (USA)


Muscle and bone interaction, D. Felsenberg (Germany)


Practical approach of glucocorticoid-treated patients, J. Adachi (Canada)


Health economics and treatment selection, J-Y. Reginster (Belgium)


BMU balance: effects of anti-osteoporotic agents, Jpston (UK)


Premenopausal osteoporosis, E. Siris (USA)


Bone mass/structure measurements during growth, R. Rizzoli (Switzerland)


Bone disease in primary hyperparathyroidism, J.P. Bilezikian (USA)


Bisphosphonates in chronic renal failure, S. Papapoulos (NL)


Pharmaco-genomics, M.L. Brandi (Italy)


Vertebro/kyphoplasty, S. Boonen (Belgium)


Issues in designing and conducting clinical trials, S. Cummings (USA)


Osteoporosis in men, E. Seeman (Australia)


Post-fracture management, K. Akesson (Sweden)


Fracture healing: can we influence it?, J. Goldhahn (Switzerland)















Genetics and osteoporosis: how to assess it?, S. Ferrari (Switzerland)


Side effects of anti fracture drugs, S. Adami (Italy)


Developmental origins of osteoporotic fracture, C. Cooper (UK)


Gait and falls, T. Masud (UK)

Don't miss the premiere global skeletal health meeting of 2010 - reserve May 5-8, 2010 on your calendar.


Notes:


Abstract submission deadline: February 4, 2010.



ABOUT IOF



The International Osteoporosis Foundation (IOF) is a nongovernmental umbrella organization dedicated to the worldwide fight against osteoporosis, the disease known as "the silent epidemic". IOF's members - committees of scientific researchers, patient, medical and research societies and industry representatives from around the world - share a common vision of a world without osteoporotic fractures. Launched in 1998 with the merger of the European Foundation for Osteoporosis (EFFO, founded in 1987) and the International Federation of Societies on Skeletal Diseases, IOF now represents 191 societies in 91 locations.



ABOUT ESCEO



The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) is a non-profit organization, dedicated to a close interaction between clinical scientists dealing with rheumatic disorders, pharmaceutical industry developing new compounds in this field, regulators responsible for the registration of such drugs and health policy makers, to integrate the management of osteoporosis and osteoarthritis within the comprehensive perspective of health resources utilization. The objective of ESCEO is to provide practitioners with the latest clinical and economic information, allowing them to organize their daily practice, in an evidence-based medicine perspective, with a cost-conscious perception.



Source:
L. Misteli


International Osteoporosis Foundation

New Way To Block Destructive Rush Of Immune Cells

Researchers have found a way to selectively block the ability of white blood cells to "crawl" toward the sites of injury and infection when such mobility drives disease, according to a study published in The Journal of Experimental Medicine. The results suggest a new treatment approach for autoimmune diseases like rheumatoid arthritis, lupus and multiple sclerosis, and for conditions made worse by misplaced inflammation, like atherosclerosis, stroke and transplant rejection, researchers said.



Where a single-celled amoeba moves to find food, human cells migrate as part of complex bodily functions like immunity. Disease-fighting cells for instance move toward bacteria and cells infected with viruses, which they target for destruction. Unfortunately, the same cells can mistakenly attack the body's own cells or drive inflammation too far, worsening the problem they rushed in to solve.



A team of researchers at the University of Rochester Medical Center has been studying proteins called integrins that enable T cells, a major subset of immune cells, to migrate. The integrin-related mechanisms described for the first time in the current paper suggest a way to shut down only those T cells currently in the act of disease-related migration, while leaving in place reserves needed in the likely event that another infection occurs during treatment. Making the mechanistic discoveries possible was a successful effort by the team to capture on video the first detailed images of fast-migrating T cells and the behavior of key proteins related to migration, which had been tagged with fluorescence. Twelve videos of T cells, and their key migration proteins, in action are part of the publication and are available online.



"There are many cases where it would be incredibly useful to precisely block integrin activation, and thus T cell migration," said Minsoo Kim, Ph.D., assistant professor of Microbiology and Immunology within the David H. Smith Center for Vaccine Biology and Immunology at the Medical Center, and lead author of the article. "Good examples include when our immune system attacks our own cells, or rejects a lifesaving transplant or clogs our blood vessels by mistake. The problem is that past, system-wide attempts that block all integrin activation, like the multiple sclerosis drug Tysabri, shut down not only unwanted inflammation in one locale, but also vital immune defenses elsewhere, leaving patients vulnerable to infection."



The Great Migration



Two mechanisms make cell migration, or programmed directional movement, possible. The first, called chemotaxis, tells the cell which direction to move in. Cell surface proteins sense and follow chemicals and molecules they are attracted to toward wherever those attractants are most concentrated. T cells, named after the thymus (T) where they mature, move toward the byproducts of bacteria and viruses.
















The second migratory mechanism is propulsion. In between infections and injuries, inactive T cells ride along with the bloodstream. T cells "realize" when they pass by part of a blood vessel wall close to the site of an injury or infection. Integrins on their surfaces unfold and grab onto key proteins on the surface of blood vessel wall cells (e.g. ICAM), resisting the surrounding blood flow. The T cells then pass through the vessel wall, and once outside the bloodstream, crawl along the tissue scaffolding toward the site of injury.



In a T cell at rest, integrins are distributed evenly over the entire surface of the T cell. When the cell gets ready to move, however, activated integrins cluster on the leading edge of the cell in the direction the cell wants to move in. They bind to their counterpart adhesion proteins like ICAM on the surface that the T cell is moving across. The T cell then contracts using its cell skeleton to pull itself over the leading edge integrins. Finally, the integrins on the trailing edge of the cell let go. Without precise changes that enable the front end to gain traction, and the tail to let go, the cell cannot migrate.



Kim's team found that a subset of integrins, including lymphocyte function???"associated antigen-1 (LFA-1), control whether or not the tail end of the T cell can "let go" (de- adhesion). Data revealed for the first time that a protein called non-muscle myosin heavy chain-IIA (MyH9) is recruited to LFA-1 at the trailing end of migrating T lymphocytes. Experiments that interfered with the association between MyH9 and the LFA-1 integrin were found to prevent the trailing edge of the crawling T cell from letting go, dramatically reducing the ability of T cells to move. Myosins are motor proteins that expend energy to enable cell skeletons to contract. That contraction creates force that is used in many cases to move muscle fibers, but in the case of MyH9, to rip the trailing end of a migrating T cell foot away from the surface it is migrating across by breaking integrin-ICAM bonds. The results provide the first evidentiary support of the longstanding theory that cell skeleton contractile force is used to drive T cell migration, with MyH9 as the mechanical link. Captured images show fluorescently tagged actin (which partners with LFA-1 to grip the surface) gathering at the front end of the cell, and fluorescently tagged MyH9 gathering at the tail end in cycles, each time the cell takes a "step."



The study was a joint effort by the Department of Surgery at Rhode Island Hospital, Brown Medical School, the Department of Physics at Brown University, the CBR Institute for Biomedical Research at Harvard Medical School and the departments of Chemical Engineering, Biomedical Engineering and Department of Microbiology and Immunology at the University of Rochester. The project was supported by the American Heart Association, the Rhode Island Foundation, the National Institutes of Health, the National Science Foundation and the Brown University Seed Grant.



In the next phase, the team will seek to develop better-targeted, anti-integrin therapies, with MyH9 among the rational targets for new classes of drugs. Toward that end, experiments currently underway are designed to determine which molecules regulate MyH9 activity during T cell migration.



"Initial clinical studies on T cell migration focused on overall blocking of migration, but general inhibition is a blunt tool," said Tim Mosmann, Ph.D., director of the David H. Smith Center for Vaccine Biology and Immunology. "As studies such as Dr. Kim's help us to understand the process more precisely, we should be able to design much more precise methods to block migration in the selected circumstances that cause problems, without crippling the essential immune responses to infections."







Source: Greg Williams


University of Rochester Medical Center



View drug information on Tysabri.

Arthritis Advisory Committee Recommends FDA Approval Of Febuxostat For The Treatment Of Hyperuricemia In Patients With Gout

Takeda Pharmaceutical Company Limited and its wholly-owned
subsidiary, Takeda Global Research & Development Center, Inc., U.S.,
announced today that the Arthritis Advisory Committee of the U.S.
Food and Drug Administration (FDA) recommended that the FDA approve
febuxostat for the treatment of hyperuricemia in patients with gout.
The vote was 12 to zero in favor of approval, with one panel member
abstaining. The vote followed presentations by Takeda Global Research
& Development Center, Inc., the FDA, and invited guest speakers. If
approved in the United States by the FDA, febuxostat will be the
first new treatment for the management of hyperuricemia associated
with gout in more than 40 years.



The FDA will review the current new drug application for febuxostat
and make its approval decision. The FDA's decision may or may not
follow the Committee's recommendation.



"Today's vote by the Arthritis Advisory Committee, recommending
approval of febuxostat for the treatment of hyperuricemia in patients
with gout, is a positive step in bringing this new treatment to
market," said Nancy Joseph-Ridge, MD, president, Takeda Global
Research & Development, Inc., U.S. "Takeda is committed to developing
innovative therapies that fulfill unmet treatment needs, and we
believe febuxostat will represent an important new option for
patients who suffer the debilitating effects of gout. In the coming
months, we will work with the FDA to complete their review, including
the design of post-marketing studies."



Febuxostat is a potent non-purine, selective inhibitor of xanthine
oxidase, which was studied for its ability to lower levels of serum
uric acid in patients with hyperuricemia associated with gout.
Hyperuricemia, elevated uric acid levels in the body, is associated
with gout, a painful type of arthritis. In clinical trials,
febuxostat 40 mg and 80 mg were shown to be effective treatments for
the management of hyperuricemia associated with gout. Both doses were
well tolerated and required no dose adjustments in patients with
renal impairment. The most commonly reported adverse events were
upper respiratory tract infections, musculoskeletal and connective
tissue signs and symptoms, and diarrhea.



About Gout and Uric Acid



Uric acid is an end-product created when the body breaks down
naturally occurring substances called purines. Hyperuricemia occurs
when this process results in elevated uric acid levels, either
through overproduction or underexcretion of uric acid or a
combination of the two. Hyperuricemia is a precursor to gout; the
higher a person's urate level, the greater the risk for developing
gout.
















Gout is the most common inflammatory arthritis in men over age 40.
According to the National Health and Nutrition Examination Survey III
1988-1994, an estimated 5.1 million Americans suffer from gout. It is
a chronic condition characterized by attacks, or "flares," marked by
intense pain, redness, swelling, and heat in the affected joint. These
symptoms are the result of an acute inflammatory response to the
presence of crystallized uric acid in the joint(s). As the disease
progresses, these attacks may become more frequent and patients may
develop large deposits of crystallized uric acid visible under the
skin, known as tophi, that can eventually lead to complications
including pain, soft tissue damage and deformity, as well as joint
destruction and nerve compression syndromes such as carpal tunnel
syndrome.



Takeda Pharmaceutical Company Limited



Takeda, located in Osaka, Japan, is a research-based global company
with its main focus on pharmaceuticals. As the largest pharmaceutical
company in Japan, and one of the global leaders of the industry,
Takeda is committed to striving toward better health for individuals
and progress in medicine by developing superior pharmaceutical
products. Additional information about Takeda is available through
its corporate website, takeda.



Takeda Pharmaceuticals North America, Inc. and Takeda Global Research
& Development Center, Inc.



Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc.
and Takeda Global Research & Development Center, Inc. are subsidiaries
of Takeda Pharmaceutical Company Limited, the largest pharmaceutical
company in Japan. The respective companies currently market oral
diabetes, insomnia and gastroenterology treatments and seek to bring
innovative products to patients through a pipeline that includes
compounds in development for diabetes, cardiovascular disease,
oncology, gastroenterology, neurology, rheumatology and other
conditions. Takeda is committed to striving toward better health for
individuals and progress in medicine by developing superior
pharmaceutical products. To learn more about these Takeda companies,
visit tpna.

Takeda Pharmaceuticals

Ultraviolet Light Therapy Is As Beneficial For Darker Skin As Lighter Skin

An analysis of more than 100 patients has confirmed for the first time that darker-skinned patients benefit as those with lighter skin when given light therapy for morphea and related diseases, UT Southwestern Medical Center researchers show.



Phototherapy is the use of ultraviolet light to treat skin disorders, ranging from common problems such as acne and psoriasis to rarer conditions such as scleroderma and morphea, a hardening of the skin.



Some clinical observations have suggested that darker skin may not respond as well to light therapy, but the new data indicate that skin type does not significantly influence the effectiveness of UVA1 phototherapy, said Dr. Heidi Jacobe, assistant professor of dermatology at UT Southwestern and lead author of the study appearing in the June edition of the British Journal of Dermatology.



"This study is good news, indicating that UVA1 phototherapy should be considered as a therapeutic option for more darkly pigmented patients," noted Dr. Jacobe, who heads UT Southwestern's phototherapy clinic, one of a select few UVA1 phototherapy units in the Southwest.



Patients with diseases such as morphea respond better when treated earlier in the course of the disease, so it's important to know whether a particular treatment such as light therapy is useful.



Researchers reviewed 101 cases treated at UT Southwestern's phototherapy clinic over a three-year period ending in 2007, noting demographic and diagnostic data, skin type and clinical outcome, using standard improvement scales.



Researchers noted that the cumulative dose used did not vary significantly between skin types, and there was little or no correlation between skin type and clinical improvement scores.



The majority of patients treated at the center were diagnosed with either morphea or scleroderma. The maladies often cause discolorations of the thickened skin, usually red or purple in color, and therefore can be disfiguring. The discoloration may initially appear similar to a bruise that doesn't go away. The cause remains a mystery, and there is no known cure.



Dr. Jacobe has helped pioneer an experimental treatment that uses a highly specific range of ultraviolet light (UVA1) for some patients. Other treatments may include topical corticosteroids, antimalarials, systemic immunosuppressive medications and physical therapy.



In 2007, Dr. Jacobe launched the nation's first and only DNA repository for adults and children with morphea. Information is also available at utsouthwestern/.



Researchers are collecting blood and skin samples to investigate genes and blood markers associated with morphea. Other information is used to identify and clarify its prevalence, its demographic distribution among race, gender and age, and recurrence rates. Currently, more women are diagnosed with the disease, but other factors aren't known. UT Southwestern dermatologists also hope to identify associated health problems that may be common for those with morphea, particularly rheumatic diseases such as lupus and rheumatoid arthritis.







Other UT Southwestern researchers involved in the study are Dr. Rachael Cayce, who has a clinical research fellowship from the Doris Duke Charitable Foundation, and medical student Julie Nguyen.



Visit utsouthwestern/dermatology to learn more about UT Southwestern's clinical services in dermatology.



Dr. Heidi Jacobe utsouthwestern/findfac/professional/0,2356,54629,00.html



Source: Russell Rian


UT Southwestern Medical Center

Merrimack Pharmaceuticals Completes Enrollment In A Phase 2 Study Of MM-093 In Patients With Rheumatoid Arthritis

Merrimack Pharmaceuticals,
Inc. announced that enrollment has been completed in a Phase 2 trial
of 100 patients that evaluates the safety and efficacy of its lead product,
MM-093, in patients suffering from rheumatoid arthritis (RA). MM-093 is a
recombinant version of human alpha-fetoprotein (AFP).


The randomized, double-blind, placebo-controlled, Phase 2 study is
being conducted at 20 centers throughout the United States. The objective
of this study is to examine the safety and efficacy of MM-093 in patients
with moderate to severe, active RA despite treatment with stable doses of
methotrexate. Each patient receives 60mg of MM-093 per week or placebo for
12 weeks and will then be followed for a period of 4 weeks. In addition to
evaluating the safety of MM-093, patients will be assessed for changes in
the signs and symptoms of their disease using standard clinical outcome
measurements for RA, such as ACR20 and DAS28 scores. Patients who complete
the study are eligible to participate in an ongoing Open-Label Extension
study, which has enrolled over 35 patients to date.



"We are pleased to have completed enrollment and are thankful for the
enthusiasm of the investigators who have worked diligently to enroll
patients," said Dr. William Slichenmyer, Senior Vice President and Chief
Medical Officer at Merrimack. "We believe MM-093 represents a promising and
novel approach to the treatment of a broad range of autoimmune diseases. We
look forward to completing the study and communicating the results later
this year."



In addition to the ongoing studies in RA, MM-093 is currently being
tested in a pilot study for patients with certain types of autoimmune
uveitis, an inflammatory disorder of the eye.



Merrimack controls a strong intellectual property estate around MM-093
including 15 issued patents and a number of pending applications, both in
the U.S. and internationally, which cover composition of matter, production
methods and therapeutic uses of the drug.



Merrimack Pharmaceuticals, Inc., is a biotechnology company focused on
the discovery and development of novel treatments for diseases in the areas
of autoimmunity and cancer. Its lead compound, MM-093, is currently in
clinical development to treat patients with rheumatoid arthritis or with
autoimmune uveitis. MM-093 is an investigational drug and has not been
approved by the U.S. Food and Drug Administration or any international
regulatory agency. The company's proprietary Network Biology discovery
platform, developed with the help of leading scientists from MIT and
Harvard, enables the high throughput profiling of protein networks as a
basis for improved validation, lead identification and speed in the
development of innovative, effective and safe therapeutics. Merrimack is a
privately-held company based in Cambridge, Massachusetts. For additional
information, please visit merrimackpharma.


Merrimack Pharmaceuticals, Inc.

merrimackpharma

Better Interaction And Education Between Rheumatoid Arthritis Patients And Care Providers Needed, New Study Indicates

UCB announced today findings from large-scale rheumatoid arthritis (RA) surveys collectively called the DESIGN study that showed patients rating themselves as having substantially less knowledge of RA therapies than their physicians and nurses believed. The survey also showed disagreement between physicians and nurses over who should be charged with patient education, as well a high level of patient dissatisfaction with the level of pain they suffer from RA. These surveys, designed to assess the attitudes of RA patients and their healthcare providers, were presented at the American College of Rheumatology (ACR) Annual Scientific Meeting.



In the global study of more than 3,300 patients, nurses and physicians, 87 percent of physicians and 90 percent of nurses believed their patients had a high level of knowledge of current RA treatments. But when asked, only 50 percent of RA patients rated their knowledge as high.



The survey also asked doctors and nurses about who should be responsible for educating patients to monitor for side effects of therapies. Only 14 percent of physicians believed that nurses should educate patients, while 68 percent of nurses thought they were best able to handle this aspect of patient care. Despite these differences, nurses, physicians and patients were aligned in terms of RA treatment goals.



"These findings help pinpoint areas for additional attention where we can better work together to improve the patient understanding of this complex disease," said Nicole Furfaro, A.R.N.P., M.S.N., study investigator at Seattle Rheumatology Associates. "Patients clearly can benefit from more interaction and education from their care providers to help bridge the gaps in knowledge and manage expectations of RA therapy."



The study also assessed RA-associated pain in U.S. and European Union (EU) patients. The survey found that 34 percent of EU and 37 percent of U.S. patients were either extremely dissatisfied or dissatisfied with their level of pain from RA. Only 12 percent of EU and 9 percent of U.S. patients were extremely satisfied or satisfied.



"This survey indicates that, despite treatment, RA patients' levels of arthritis pain remain high in both the EU and the U.S. and effective pain management remains an extensive unmet need," Furfaro said.



Patients reported dissatisfaction within the 30 days prior to the survey and most patients reported moderate to severe pain in the past two months. Not surprisingly, there was a significant correlation between arthritis pain and mood and tension levels.



"It is understandable that arthritis pain would significantly affect quality of life for patients," said Arthur Kavanaugh, M.D., study investigator at the University of California, San Diego School of Medicine. "With recent advances in treatment and continuing understanding of the pathophysiology of RA, the goals of treatment have been elevated. Even though a number of patients can do extremely well with current agents, there is still room for improvement in the therapies offered to manage RA symptoms and achieve the highest levels of disease control."
















Forty-four percent of U.S. patients rated pain relief as the top benefit wanted from their RA medication, and they were satisfied with a biologic therapy if pain reduction was provided. Most EU respondents were satisfied with their biologic therapy, although pain relief was not cited as the leading reason for their satisfaction.



The DESIGN study was sponsored by UCB. Additional findings will be presented or published at a later date.



About DESIGN Study


The international DESIGN (DEveloping SuperIor understandinG of RA patients' Needs) study is one of the largest international Rheumatoid Arthritis (RA) surveys to explore the attitudes and behaviors of RA patients and their physicians regarding RA and its treatment, and assess emotional, informational, and clinical needs. The goal of the study is to highlight the burden of RA on the patient and create awareness around the importance of strong relationships between the patient and their treating rheumatologist.



Quantitative data was collected via a 45-minute phone or internet surveys fielded to 2,795 RA patients (18+ years of age; US = 2,039 RA patients; EU = 756 RA patients), 500 rheumatologists and 101 RA nurses between February and March 2008. The surveys were conducted by the bioStrategies Group. Survey questions covered disease status, disease knowledge and severity, rheumatologist visits and relationships to providers, RA treatments, as well as emotions, attitudes, and behaviors related to RA. Patient demographics and results of the EU and U.S. survey:


Mean age (y) EU (n=756) 60 - U.S. (n=2,039) 54

% females EU (n=756) 76 - U.S. (n=2,039) 79

Mean disease duration (y) EU (n=756) 12 - U.S. (n=2,039) 8

% moderate to severe RA EU (n=756) 77 - U.S. (n=2,039) 83

% taking prescription RA medication EU (n=756) 98 - U.S. (n=2,039) 92

% currently taking a biologic EU (n=756) 24 - U.S. (n=2,039) 34

Extremely dissatisfied/dissatisfied EU (n=756) 34 - U.S. (n=2,039) 37

Extremely satisfied/satisfied EU (n=756) 12 - U.S. (n=2,039) 9

Experienced moderate to severe pain in past 2 months (%) EU (n=756) 75 - U.S. (n=2,039) 82

Feel their life will be filled with pain (agree/strongly agree, %) EU (n=756) 31 - U.S. (n=2,039) 39

Worried medicine will not be strong enough to control pain (agree/strongly agree, %) EU (n=756) 37 - U.S. (n=2,039) 52





About Rheumatoid Arthritis


Rheumatoid arthritis (RA) is a progressive autoimmune disease that causes chronic inflammation of the joints. It is estimated that five million people suffer from RA globally, with 0.3 percent to 1 percent of the population in industrialized countries suffering from RA. It is estimated that, approximately 1.3 million people in the United States have RA. Women are three times more likely to be affected than men. Although it can affect people of all ages, the onset of RA usually occurs between the ages of 35-55.



Symptoms of RA include joint stiffness, joint pain, inflammation of the affected areas and an associated reduction in mobility. These symptoms can be intermittent and vary in severity from patient to patient. In more severe cases RA can eventually lead to disability. RA patients are also at a higher risk of developing other conditions, in particular heart disease, stroke, infections, lung problems and osteoporosis.



As there is currently no cure for RA, treatment goals center on disease management and controlling symptoms. Treatment is aimed at controlling disease progression, providing pain relief and reducing swelling, preventing joint damage and deformity and maintaining function of the affected joints to prevent disability.



Traditional treatments for RA include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids and disease-modifying antirheumatic drugs (DMARDs), with biological therapies a more recent addition. Anti-TNF (TNF-alpha; Tumor Necrosis Factor) therapies are specific types of biological therapies which have been used in patients with RA. They may be given alone but are usually given in combination with methotrexate or another immunosuppressant. They work by inhibiting the action of TNF-alpha, an inflammatory mediator, either directly or indirectly responsible for damaging the joint.



About UCB


UCB, Brussels, Belgium (ucb-group) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing around 12 000 people in over 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB is listed on Euronext Brussels (symbol: UCB). UCB's North American headquarters is located in Atlanta, Ga. ucb-group/



Forward-looking statement


This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.


UCB