AbbVie announced that the Food and Drug Administration (FDA) has approved Humira (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa (HS), the first drug approved for this condition.

The FDA approval is based on the results of two Phase 3 studies: PIONEER I and PIONEER II. The two trials randomized 633 patients with moderate to severe HS to receive either Humira or placebo in addition to their daily topical antiseptic. Study results demonstrated that treatment with Humira led to more reductions in the total number of abscesses and inflammatory nodules compared to patients given placebo.

“The symptoms of HS, including inflamed nodules and abscesses, can have a significant impact on patients during their most active years of life,” said Alexa Kimball, MD, MPH, director of the Clinical Unit for Research Trials and Outcomes in Skin at Massachusetts General Hospital, professor of dermatology at Harvard Medical School and principal investigator. “Adalimumab significantly reduced the signs of HS in clinical trials, and this FDA approval provides a much needed development in treatment options for patients.”

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Humira is a tumor necrosis factor blocker also approved to reduce the signs and symptoms of moderate to severe rheumatoid arthritis, moderate to severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate to severe Crohn’s disease; to induce remission in moderate to severe ulcerative colitis, and to treat moderate to severe chronic plaque psoriasis.

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