FDA Approves Remicade for Psoriatic Arthritis

Psoriatic arthritis affects over one million Americans. This autoimmune disorder (the body's immune system attacks body cells), is characterized by a number of different symptoms, including the painful swelling of joints and psoriasis. Psoriasis, a skin disease, produces grey scaly spots on the scalp, elbows, knees and back. Men and women are affected equally by this form of arthritis, which can develop at any age (appearing most commonly between the ages of 30 and 50). In most instances, psoriasis symptoms occur years before the patient begins to suffer from arthritis. Several forms of suppressive treatment for psoriatic arthritis sufferers have been available for some time. Unlike some of the other treatments, a drug called Remicade (chemical name: Infliximab), effectively reduces arthritis pain in addition to treating psoriasis. Remicade, a drug used to treat rheumatoid arthritis, has just been FDA-approved for psoriatic arthritis treatment.

Treatments for psoriatic arthritis currently revolve around two classes of drugs: NSAIDs and disease-modifying anti-rheumatic drugs (DMARDS). NSAIDs are usually included in early treatment, but are supplemented by DMARDs if the pain and the coexisting psoriasis are in advanced stages. There are several different types of DMARDS, beginning with Methotrexate. Methotrexate is the first choice because it treats both the skin disease aspect and articular pain, and its short term side-effects (e.g. tiredness) are tolerable. Long-term Methotrexate use, however, sometimes leads to liver damage; a small percentage of patients, approximately 1 out of 200, will develop reversible liver scarring after a cumulative dose of 1.5 grams.

Sulfasalazine is another option for treating painful joint arthritis but it does little to suppress psoriasis. Unlike Sulfasalzine, Cyclosporin A is used to treat both the skin disease and psoriatic arthritis. Unfortunaetly, Cyclosporin A has also been shown to cause hypertension in one out of five patients. Enbrel is yet another option which has reduced signs and symptoms of psoriatic arthritis along with stopping further degeneration of joints. Enbrel, though, works best in conjunction with methotrexate.

Fortunately, though, Remicade is now another approved option for psoriatic arthritis sufferers. The basis for the FDA's approval of Remicade came from a multinational trial conducted in October 2004. The Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT 2), a phase III trial, IMPACT was a randomized, double-blind study with 104 patients suffering from psoriatic arthritis; these patients were enrolled at nine centers throughout the United States, Canada and Europe. The trial showed that Remicade provided a 70% improvement or greater in symptoms of arthritis in 27% of test patients, compared with the less than 3% of patients administered a placebo for 24 weeks. These changes were measured by ACR 70, a form of the American College of Rheumatology (ACR) response criteria. Treatment with Remicade also resulted in a dramatic 90% or greater improvement in PASI (Psoriasis Area and Severity Index) score for nearly 40% of patients, while a 100% improvement in PASI score was shown for 21% of patients. None of the placebo patients saw an improvement. Improvement in arthritis and psoriasis was seen early (in week two) and maintained throughout the study. Remicade was specifically successful in treating dactylitis and enthesopathies, two common manifestations of psoriatic arthritis.

Article References
http://www.arthritis.org/conditions/DiseaseCenter/psoriatic_arthritis.asp, site accessed on 5/30/05

http://www.skinsite.com/info_methotrexate.htm, site accessed on 5/30/05

http://www.centocor.com/cgi-bin/site/media/media_newsarch.cgi?news_id=67, site accessed 5/30/05