четверг, 29 сентября 2011 г.

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.

понедельник, 26 сентября 2011 г.

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

пятница, 23 сентября 2011 г.

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

вторник, 20 сентября 2011 г.

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

суббота, 17 сентября 2011 г.

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

среда, 14 сентября 2011 г.

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

воскресенье, 11 сентября 2011 г.

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.

четверг, 8 сентября 2011 г.

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

понедельник, 5 сентября 2011 г.

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

пятница, 2 сентября 2011 г.

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.