HUMIRA Wins Expanded Approval in Psoriatic Arthritis Indication
HUMIRA Wins Expanded Approval in Psoriatic Arthritis Indication
Based on data from an extension of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), the U.S. Food and Drug Administration has approved an expanded indication for Abbott's HUMIRA that now includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis (PsA).
ADEPT was a Phase III trial involving 313 patients with moderate to severe PsA who had an inadequate response to treatment with non-steroidal anti-inflammatory drugs (NSAIDs). It was the largest randomized, placebo-controlled biologic trial in PsA. Results demonstrated that patients taking HUMIRA experienced significantly less joint damage than patients taking placebo. More than three times as many patients on placebo (29 percent) experienced joint damage compared to patients taking HUMIRA (9 percent) at week 24. Results in the HUMIRA group were maintained through 48 weeks.
PsA is a chronic disease that combines the symptoms of arthritis, including joint inflammation, which leads to pain and possible damage, with symptoms of psoriasis, such as painful, raised red lesions covered by silvery white scales. The expanded indication in PsA could prove to be very beneficial to patients, as it is thought that early recognition, diagnosis and treatment of PsA may help inhibit extensive joint involvement and damage in later stages of the disease, in addition to relieving pain and inflammation.
HUMIRA is currently approved to treat rheumatoid arthritis, PsA and ankylosing spondylitis, or arthritis of the spine, in both the United States and Europe. HUMIRA is currently under regulatory review to treat Crohn's disease, and additional development work continues in psoriasis, ulcerative colitis and juvenile rheumatoid arthritis.
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