FDA, EMEA accept Humira application for treatment of psoriatic arthritis
First posted Dec. 22, 2004
Abbott Laboratories announced on Dec. 16, 2004 that both the U.S. Food and Drug Administration (FDA) and its European equivalent, the European Medicines Agency (EMEA), accepted its application requesting approval of Humira (generic name adalimumab) for the treatment of psoriatic arthritis. Humira was approved in the U.S. in December 2002 and in Europe in September 2003 for the treatment of rheumatoid arthritis.
Humira has been prescribed "off-label" for psoriasis and psoriatic arthritis, based on the results of multiple clinical trials. However, some insurance companies in the U.S. will not cover off-label usage because the FDA has not given formal approval for its use in treating psoriasis and psoriatic arthritis. FDA approval typically takes about one year for new drugs; however, because Humira is already on the market, it may take less time for the FDA to approve a new use of the medication. Abbott estimates it may be approved in Europe in the second half of 2005.
In a phase III trial for psoriatic arthritis, Humira was shown to improve both skin and joint symptoms of psoriatic arthritis. In a double-blind, placebo-controlled study of 313 patients with active psoriatic arthritis, researchers monitored joint symptoms and the skin of patients who had an inadequate response to treatment with non-steroidal inflammatory drugs (NSAIDs).
The patients received placebo or 40 milligrams of Humira given subcutaneously (under the skin) every other week. Humira was studied for 24 weeks. By week 24, 75 percent of patients improved their psoriasis severity score by half; nearly 60 percent improved their psoriasis severity score by 75 percent and more than 40 percent improved by 90.
At week 24, nearly one quarter achieved 70 percent improvement in their arthritis measurement score; nearly 40 percent achieved 50 percent improvement in the score; and more than half achieved 20 percent improvement in the score.
The Psoriasis Foundation welcomes the news as continuing this historic new era for psoriasis and psoriatic arthritis patients through the development and approval of appropriate treatments.
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