
Approval of a first-in-class biologic drug for rheumatoid arthritis and development of the first new drug for gout in 40 years top the Arthritis Foundation’s list of the most significant arthritis advances of 2005. New understanding of the importance of personal lifestyle choices in relieving pain and strides made in drug safety and access to medications also are among the top 10 advances expected to improve the lives of people with arthritis and related diseases in the year ahead.
The following advances in research, public health and public policy – including several supported by the Arthritis Foundation – provide hope for millions of patients and hint at breakthroughs that are possible in the future.
1. New Biologic Drugs for Rheumatoid Arthritis (RA) – Abatacept (Orencia), the first biologic in a class of co-stimulation modulators for RA, was approved by the U.S. Food and Drug Administration (FDA) on December 23, 2005. Rituximab (Rituxan), another biologic drug, is currently approved for CD20-positive, B-cell non-Hodgkin’s lymphoma, and is under consideration by the FDA for use in RA. RA patients now have more treatment options than ever before, which means greater ability to reduce both disease symptoms and the risk of disability.
2. First New Drug for Gout in More Than 40 Years – Febuxostat, a new treatment for gout, was shown to be more effective at lowering uric acid levels than allopurinol, the current standard treatment for gout. Elevated uric acid levels lead to acute and chronic pain and inflammation and, over time, to joint damage. If approved by the FDA, febuxostat would be the first new drug in more than 40 years for the 2.1 million Americans with gout and an alternative for patients who cannot tolerate or fail to respond to current medications.
3. Weight Loss and Exercise Shown to be Beneficial – The Arthritis Foundation funded research that provided pilot data for an important study showing that lack of regular vigorous physical activity nearly doubled an arthritis patient’s risk for functional decline and eventual disability. In fact, researchers found that expected two-year rates of functional decline in older arthritis patients could have been reduced by up to 32 percent with regular physical activity. A separate study co-authored by Arthritis Foundation research alumnus Kevin Fontaine, PhD, showed that even in obese persons, losing as little as 15 pounds is associated with nearly 50 percent improvement in knee osteoarthritis (OA) symptoms such as knee pain, stiffness and functional impairment.
4. Osteoporosis Treatment Advances Reduce Fracture Risk – New research showed that strontium ranelate significantly increased bone formation and slowed bone destruction, reducing the risk of fractures in postmenopausal women with osteoporosis. Other research showed that a once-monthly dose of ibandronate sodium (Boniva) was shown to be well tolerated and more effective in increasing bone mineral density than the currently available daily regimen. The once-monthly dose is expected to increase patient compliance.
5. Major Advances in Lupus Treatment – Two important studies are likely to significantly influence the clinical treatment of the autoimmune disease lupus. Mycophenolate mofetil (CellCept), a drug commonly used to prevent organ transplant rejection, showed promise in inducing remissions in patients with the most severe form of lupus nephritis (kidney disease) and was superior to the standard-of-care regimen of intravenous cyclophosphamide. Other research showed that oral contraceptives and hormone replacement therapy are safe in women with lupus, bringing welcome news for lupus patients whose physicians have been reluctant to prescribe estrogens for fear of exacerbating the disease.
6. Success in Treating Children with Juvenile Arthritis – Researchers discovered that the white blood cells of children with Still’s disease, a particular type of juvenile arthritis, secreted higher levels of interleukin-1 (IL-1), a protein that regulates the immune system. In a small pilot study, anakinra (Kineret), a biologic agent that blocks IL-1, was shown to be highly effective in inducing remission in a majority of the children studied. In another important contribution, a systematic review of controlled juvenile arthritis trials published since 1966 provided an invaluable summary of evidence that will assist doctors in the treatment of juvenile arthritis. This review brought attention to the need for individual treatment plans based on disease subtype and quality standards for the care of children with arthritis.
7. Safety Questions on Arthritis Drugs – Following the withdrawal of two COX-2 selective inhibitors from the market and strengthened warnings on labels of all prescription and over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs) except aspirin, several articles about the relationship between this class of drugs and cardiovascular events were published, including a notable review by Arthritis Foundation-funded researcher Daniel Solomon, MD. In December, the Cleveland Clinic announced a large-scale study examining the risks of NSAIDs in patients with high cardiovascular risk. Results of this and future trials should provide more definitive drug safety information for the millions of patients with various forms of arthritis who continue to rely on this class of medications for pain relief and the doctors who treat them.
8. Novel Methods to Prevent and Predict OA Joint Destruction – Researchers found that high doses of the osteoporosis drug risedronate (Actonel) preserved underlying bone in OA patients with joint space narrowing and may delay joint destruction in patients with severe knee OA – a welcome finding in the search for disease-modifying osteoarthritis drugs. In a separate study funded in part by the Arthritis Foundation, researchers discovered that measuring blood levels of hyaluronic acid, a component of connective tissue, may help with early OA detection, allowing doctors to more quickly and effectively target patients in need of treatment and to better monitor patient response to treatment.
9. Genetic Clues to Autoimmune Dysfunction – The North American Rheumatoid Arthritis Consortium (NARAC), jointly funded by the Arthritis Foundation and the National Institutes of Health, has discovered a gene variation linked to an increased risk for RA, lupus and other autoimmune disorders. When this gene variation is present, the immune system isn’t able to shut down appropriately, resulting in chronic inflammation and tissue damage. Within the next five years, NARAC researchers expect to identify the various genes involved in autoimmune conditions, which will lead to better diagnostic methods, the ability to predict disease severity and individually tailored treatment approaches.
10. Most Significant Expansion of Seniors’ Access to Arthritis Medications – In 2005, nearly 16,000 Medicare beneficiaries with RA and psoriatic arthritis participated in a program that provided coverage for breakthrough biologic therapies. January 2006 marked the beginning of the Medicare Part D prescription drug plan, giving seniors better access to life-changing medications and greater opportunities for self-sufficiency and mobility. The Arthritis Foundation supported passage of the Medicare Modernization Act, which launched the new Part D benefit as well the self-injectable demonstration project, and supported efforts to increase consumer awareness about the new benefit.
To develop its annual list of the top 10 arthritis advances, the Arthritis Foundation seeks input from clinicians with expertise in various forms of arthritis, scientists from a wide variety of research disciplines, and organizations with an interest in arthritis and related diseases.