ABBOTT'S HUMIRA APPROVED FOR PSORIATIC ARTHRITIS

Abbott has announced that the FDA approved an expanded indication for Humira (adalimumab) that includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis. The expanded indication is in addition to the psoriatic arthritis approval granted in 2005.

Psoriatic arthritis is a chronic disease that combines symptoms of arthritis, including joint pain and inflammation, and those of psoriatic skin disease, such as painful, raised red lesions covered by silvery white scales. Humira is also approved in the U.S. for use in moderate to severe rheumatoid arthritis and active ankylosing spondylitis.

The expanded indication is based on results from an extension of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), the largest randomized, placebo-controlled biologic trial in psoriatic arthritis. ADEPT was a Phase III, controlled study in 313 patients with moderate to severe psoriatic arthritis who had an inadequate response to non-steroidal anti-inflammatory drug therapy. Patients were randomized to receive either Humira 40 mg every other week or placebo. At week 24, 285 patients elected to enroll in a 24-week, open-label extension.

Patients taking Humira experienced significantly less joint damage than patients taking placebo. Humira patients also showed significant improvement in physical function as assessed by the Health Assessment Questionnaire Disability Index score and the Short Form-36 Health Status Survey. Finally, patients' arthritic symptoms responded to Humira, with nearly 60 percent of patients achieving American College of Rheumatology scores of 20 through week 24, indicating a 20 percent or greater improvement in tender and swollen joint counts and several other clinical measures.