Abbott received approval for an expanded indication for Humira that includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis (PsA). Humira is also approved in the U.S. for use in moderate to severe rheumatoid arthritis (RA) and active ankylosing spondylitis (AS).
PsA 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. Approximately one million people suffer from PsA in the U.S.
Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT) was a Phase III, controlled study in 313 patients with moderate to severe PsA, who had an inadequate response to NSAID (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.