FDA approval for Humira for psoriasis

Journal of Drugs in Dermatology, March, 2008 by Marissa Heller

The FDA recently granted approval to Abbott to market Humira[R] for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Humira had previously been approved to treat rheumatoid arthritis, ankylosing spondylitis, and Crohn's disease. Humira works by blocking tumor necrosis factor alpha.

This approval is based on data from 2 large, randomized, controlled, double-blind trials, REVEAL and CHAMPION, which studied more than 1400 adult patients. These studies show that almost 75% of patients treated with Humira achieved a PASI 75 at week 16 of treatment when compared to a placebo. Furthermore, almost 50% of patients achieved a PASI 90, and 20% of patients achieved a PASI 100 when treated with Humira as compared to a placebo.

The most commonly reported side effects of treatment with Humira are upper respiratory infection, nasopharyngitis, headache, sinusitis, and arthralgia. Administration of Humira is by self-administered injection. The standard treatment regimen for Humira is an 80 mg initial dose followed by a 40 mg dose after 1 week. Subsequently, patients are treated with a maintenance dose of 40 mg every other week.