Humira received expanded FDA approval in treatment of psoriatic arthritis

Journal of Drugs in Dermatology, Jan, 2007 by Marissa Heller

The FDA recently expanded the indications in its approval for Humira (adalimumab) in the treatment of psoriatic arthritis. Humira is a TNF-alpha blocker and represents the only fully human monoclonal antibody that is approved in the US for the treatment of psoriatic arthritis, ankylosing spondylitis, and rheumatoid arthritis. The original approval of this medication was granted in October of 2005.

The new indications include inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis. These new indications arose from data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). This Phase III, randomized, placebo-controlled trial included 313 patients with moderate-to-severe psoriatic arthritis who received either Humira 40 mg SC every other week or placebo. Patients treated with Humira were noted to have significantly less joint damage and significantly more improvement in physical function as compared to those treated with placebo. The most commonly described adverse effects associated with Humira are injection site reactions, upper respiratory infections, headache, rash, and sinusitis.