FDA accepts Remicade application for treatment of psoriatic arthritis
First posted Dec. 6, 2004
Centocor, Inc. announced on Dec. 1, 2004, that the U.S. Food and Drug Administration (FDA) accepted its application requesting approval of Remicade for the treatment of psoriatic arthritis. Remicade was approved in 1998 for the treatment of Crohn's disease and is also approved to treat rheumatoid arthritis.
Remicade has been prescribed "off-label" for psoriasis and psoriatic arthritis, based on the available evidence. However, some insurance companies will not cover off-label usage because the FDA has not given formal approval for it to treat psoriasis and psoriatic arthritis. FDA approval typically takes about one year for new drugs; however, because Remicade is already on the market, it may take less time for the FDA to approve a new use of the medication.
In a phase III trial for psoriatic arthritis, Remicade was shown to improve both joint and skin symptoms. In a double-blind, placebo-controlled study of 200 patients with active psoriatic arthritis, researchers monitored joint symptoms and the skin.
Determining arthritis measurement scores by week 14 in those using 5 mg/kg of infliximab:
- about 60 percent achieved 20 percent improvement
- more than 45 percent achieved 50 percent improvement
- nearly 30 percent achieved 70 percent improvement
About half of the patients studied were also using methotrexate, which did not significantly affect the improvement level. In measurements of psoriasis severity, more than 60 percent of those using infliximab achieved 75 percent improvement in their score by week 14.
The Psoriasis Foundation welcomes the news as continuing a historic new era for psoriasis and psoriatic arthritis patients through the development and approval of appropriate treatments.
| 
