FDA Clears Adalimumab (Humira) for Hidradenitis Suppurativa

Megan Brooks

Disclosures

September 11, 2015

The US Food and Drug Administration (FDA) has approved the tumor necrosis factor inhibitor adalimumab (Humira, AbbVie) for the treatment of moderate to severe hidradenitis suppurativa (HS), making it the first and only FDA-approved therapy for HS, the company said.

The FDA granted adalimumab orphan drug status back in May for the treatment of moderate to severe HS (Hurley Stage II and Hurley Stage III disease), which affects fewer than 200,000 patients.

HS is a chronic inflammatory skin disease characterized by inflamed, painful lesions typically located around the armpits and groin, on the buttocks, and under the breasts.

"The symptoms of HS, including inflamed nodules and abscesses, can have a significant impact on patients during their most active years of life," Alexa Kimball, MD, professor of dermatology, Harvard Medical School and director, Clinical Unit for Research Trials and Outcomes in Skin, Massachusetts General Hospital, Boston, said in a news release.

"Adalimumab significantly reduced the signs of HS in clinical trials, and this FDA approval provides a much needed development in treatment options for patients," said Dr Kimball, who led the trials of adalimumab in HS, known as PIONEER I and PIONEER II.

In the trials, 633 adults with moderate to severe HS were randomly assigned to receive either adalimumab or placebo in addition to daily use of topical antiseptic. Both studies showed that more patients given adalimumab had reductions in the total number of abscesses and inflammatory nodules than patients given placebo, with no new safety risks, the company said.

The European Commission approved adalimumab for treatment of active moderate to severe HS in adults with an inadequate response to conventional systemic HS treatment in July.

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