First Treatment Approved for Painful Skin Disease

The findings from a pair of phase 3 clinical trials of adalimumab (Humira) led to its approval by the FDA to treat hidradenitis suppurativa (HS), a painful inflammatory skin disease.

The tumor necrosis factor (TNF) inhibitor is the first treatment approved for HS.

“HS is a devastating disease affecting young women and men with painful, disfiguring boils and abscesses, primarily in the armpits and groin,” said lead author Alexa Kimball, MD, MPH. “Both physical functioning and quality of life are severely affected, and while many treatments are used to relieve symptoms and try to get the disease under control, this largest set of placebo-controlled information to date clearly shows that improvement can result for patients.”

The studies PIONEER 1 and PIONEER 2, published by the New England Journal of Medicine, were sponsored by AbbVie, who markets adalimumab (Humira) for inflammatory skin conditions. HS effects areas containing apocrine sweat glands.

The disease is thought to be caused my immune system irregularities and increased levels of cytokines. Humira inhibits TNH activities.

In the phase 2 trial, researchers found that adalimumab was more effective reducing symptoms and pain compared with placebo. The phase 3 trials enrolled more than 300 patients with moderate-to-severe HS.

Patients were divided into 2 groups that either received Humira or placebo for the first 12 weeks. In PIONEER 1, patients in the placebo group received the drug for the next 24 weeks.

Patients in the other group were split into 3 subgroups. Patients in the subgroups either received the drug weekly, every other week, or received placebo.

In PIONEER 2, patients in the placebo group would continue to receive the placebo for the next 24 weeks, and the other group would also be split into the 3 subgroups. Researchers found that Humira was able to provide symptom relief more effectively than the placebo without any serious adverse events, according to the study.

They also found little difference between patients taking the weekly dose compared with patients taking biweekly doses or a placebo. Researchers noted that the severity of HS fluctuates, and treatment was discontinued in patients whose symptoms stopped responding.

This shows the need for a larger study to create an ideal length and frequency of treatment.

“These results are exciting because they open up a whole new era for HS research and treatment,” Dr Kimball concluded. “HS has been underappreciated and understudied, and this kind of research, showing not only that these studies can be done well but also that we can improve our patients' symptoms, can only lead to further advances.”