The FDA first approved REMICADE for psoriatic arthritis in May 2005. In September 2004, REMICADE received European Union (EU) approval, in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease-modifying anti-rheumatic drugs (DMARDs). Then, in July 2006, the European Commission approved the use of REMICADE for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to DMARDs to be used in combination with methotrexate or alone in patients who show intolerance to methotrexate or in whom methotrexate is contraindicated.
Psoriatic arthritis is chronic inflammatory disease that affects both men and women, most commonly between the ages of 30 and 50. Symptoms include joint pain and swelling that can lead to joint destruction and debilitation. Skin psoriasis is frequently associated with the disease, resulting in scaly, red patches of skin. Other symptoms may include stiffness and tenderness of the joints and surrounding tissue, reduced range of motion, nail changes and redness and pain of the eye (uveitis). Psoriasis affects approximately two to three percent of the world's population, and approximately one out of three patients affected by psoriasis may develop psoriatic arthritis.
REMICADE acts to inhibit progression of structural damage and improve physical function in patients with psoriatic arthritis, in addition to reducing signs and symptoms of active arthritis. The FDA extended approval is based on one-year data from the double-blind, placebo-controlled trial IMPACT 2 and two-year data from the double-blind, placebo-controlled trial IMPACT. Findings from IMPACT 2 showed that at week 24, REMICADE-treated patients had less structural damage were more than twice as likely to achieve a clinically meaningful improvement in physical function compared with patients receiving placebo.
Fifty percent of REMICADE- treated patients maintained at least 75 percent improvement in psoriasis symptoms from their baseline over one year, as assessed by Psoriasis Area Severity Index (PASI 75), while 64% percent of REMICADE-treated patients in IMPACT maintained PASI 75 through two years. Forty-two percent of REMICADE-treated patients in IMPACT 2 achieved near total skin clearance (90%) at one year, and 48 percent in IMPACT achieved PASI 90 through two years.