Humira Approved by FDA to Treat Skin Disease

The FDA today approved adalimumab (Humira) to treat moderate to severe hidradenitis suppurativa (HS), an inflammatory skin disease.

According to AbbVie, Humira is now the first and only FDA-approved therapy to treat HS among adults.

In trials involving 633 patients with moderate to severe HS, patients were randomly assigned to receive either the intervention treatment or placebo with daily use of topical antiseptic. Patients who received Humira were more likely to have reductions in the total number of abscesses and inflammatory nodules than those who received placebo.

Adverse effects may include injection site reactions, upper respiratory infections, headaches, rash, and nausea.

“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, 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, said in a press 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.”

Humira has also been approved to help treat moderate to severe rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease, ankylosing spondylitis, severe ulcerative colitis, and moderate to severe chronic plaque psoriasis.