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Adalimumab a “Proven” Therapy for Hidradenitis Suppurativa

Summary and Comment |
December 21, 2012

Adalimumab a “Proven” Therapy for Hidradenitis Suppurativa

  1. Jeffrey P. Callen, MD

Weekly treatment produced a small but statistically significant improvement in moderate to severe disease.

  1. Jeffrey P. Callen, MD

Hidradenitis suppurativa (HS) is one of the most difficult diseases to treat that I encounter in my practice. The disease most frequently affects young women. It is associated with obesity, smoking, and depression, and with a lower health-related quality of life than many other dermatologic diseases. Oral antibiotics have been the standard treatment for years, but many patients have a minimal response. With the exception of ablative surgery, other treatments, including retinoids and systemic corticosteroids, with or without immunosuppressive agents, have temporary or disappointing effectiveness. In patients with accompanying inflammatory bowel disease (IBD), infliximab infusion has been observed to improve the HS as well as the IBD. This observation led to case reports in which tumor necrosis factor (TNF) antagonists were seen to benefit HS, even in the absence of IBD.

These investigators, with support from Abbott Laboratories, conducted a double-blind, placebo-controlled trial of 40-mg adalimumab given weekly or every other week. The primary endpoint was a physician global assessment score of HS indicating clear, minimal, or mild disease. A 16-week placebo-controlled phase was followed by an open-label extension of up to 1 year using every-other-week dosing. The investigators found a statistically significant benefit with weekly treatment compared with placebo; efficacy was partially lost in the weekly-dose group when they switched to every-other-week dosing. Dermatology Life Quality Index scores improved correspondingly. About 10% of patients had one or more serious adverse events, without significant differences among patient groups. One patient developed ulcerative colitis and gastrointestinal bleeding (whether this patient was receiving active treatment is not reported); and one adalimumab recipient developed coccidioidomycosis. No tuberculosis or cancers were noted.

Comment

Only 13.7% of weekly-dose patients achieved the primary end point. Although this is statistically significant, it is not a “blockbuster” response, in my opinion. In the supplemental graphs available with the article, the best response at week 52 appears to occur in the group that went from placebo to every-other-week dosing, but fewer than 20% achieved clearing or minimal disease. My experience with a few patient recipients of tumor necrosis factor antagonists suggests that etanercept has little effect, infliximab has some effect, and adalimumab's effect is intermediate. I have to wonder whether we would see different responses with golimumab or certolizumab.

Bottom line: There is a statistically significant response of hidradenitis suppurativa to weekly adalimumab. We can hope that practitioners will be able to use these data to get a TNF antagonist approved for use in HS.

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