Abbott Laboratories (ABBOTT PARK, Illinois), announced it has received US FDA approval to market Humira® (adalimumab) for adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. The approval is based on two pivotal trials, REVEAL and CHAMPION, with data from more than 1400 adult patients showing that nearly three in four patients achieved >e;75% clearance at week 16 of treatment versus placebo. In addition, CHAMPION compared Humira with methotrexate (MTX). In each trial, reduction in disease activity was determined by the Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA).

In the 52-week REVEAL trial, the short-term and sustained clinical efficacy and safety of Humira were evaluated in more than 1200 patients from the US and Canada with moderate-to-severe chronic plaque psoriasis. At week 16, patients experienced a significant reduction in the signs and symptoms of their disease when treated with the drug. Specifically, 71% of treatment patients achieved PASI 75 compared with 7% of patients receiving placebo. Also at week 16, fully 62% of Humira-treated patients achieved a PGA score of clear or minimal (0 or 1) compared with 4% of placebo-treated patients.

In the 16-week CHAMPION trial evaluating 271 psoriasis patients from eight European countries and Canada, Humira-treated patients experienced a significant reduction in the signs and symptoms of their disease compared with MTX or placebo-treated patients. A total of 78% of patients treated with the drug (N = 99) achieved a PASI 75 response compared with 19% of patients treated with placebo (N = 48). A total of 71% of patients treated with the drug achieved a PGA score of clear or minimal at 16 weeks of treatment compared with only 10% of placebo-treated patients.

The safety profile of Humira in the plaque psoriasis clinical trials was similar to that seen in Humira clinical trials for rheumatoid arthritis. The most commonly reported adverse events in the trials were upper respiratory tract infection, nasopharyngitis, headache, sinusitis, and arthralgia. Humira is self-administered as an injection with an initial dose of 80 mg (two 40 mg injections) followed by one injection (40 mg) 1 week later. Thereafter, a maintenance dose of 40 mg is administered every other week. Humira should only be prescribed to patients who will be closely monitored and have regular follow-up visits with a physician.

In April 2007, Abbott simultaneously submitted a supplemental Biologics License Application (sBLA) with the FDA and a type II variation to the European Medicines Agency (EMEA) seeking approval to market Humira as a treatment for chronic plaque psoriasis. EMEA approval was received in December 2007, and the US approval makes psoriasis the fifth autoimmune disease indication for the drug. Humira was approved for moderate-to-severe RA in 2002, psoriatic arthritis in 2005, ankylosing spondylitis in 2006, and moderate-to-severe Crohn's disease in 2007.