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The results of a pilot study suggest that the interleukin-1(IL-1) receptor antagonist anakinra may be a potential treatment option for hidradenitis suppurativa (HS).
The cause of HS – a chronic skin disorder affecting areas with apocrine glands leading to nodules, inflammation, rupture, and scarring – is unknown but is thought to be related to excessive inflammation and autoinflammatory mechanisms, noted the authors, Dr. Vassiliki Tzanetakou of the Fourth Department of Internal Medicine at the University of Athens, and his associates.
They evaluated the safety and efficacy of anakinra for the treatment of HS in a double-blind, randomized, placebo-controlled study of 20 patients with Hurley stage II or III HS (10 in each arm). Participants received 12 weeks of once-daily subcutaneous injections of anakinra or placebo. The study, which the authors believe is the first double-blind, randomized study to evaluate the safety and efficacy of anakinra in people with HS, was published on-line in JAMA Dermatology on Nov. 18 (doi:10.1001/jamadermatol.2015.3903).
One patient in the anakinra arm was lost to follow-up. At week 12, the end of the treatment period, a decrease in the disease activity score – the primary endpoint – was seen in 67% (6 of 9) of those in the anakinra arm, vs. 20% (2 of 10) in the placebo arm (P = .04). HS clinical response at 12 weeks was demonstrated in 78% (7 of 9) with anakinra, vs. 30% (3 out of 10) with placebo (P = .04). In addition, the time to a new HS exacerbation, a secondary endpoint, “was significantly prolonged” among those on anakinra (P = .01), they said.
One patient in the anakinra group stopped the medication after 4 weeks because of diarrhea; however, the authors noted no serious adverse events.
At baseline, 12 and 24 weeks, peripheral blood mononuclear cells from the patients were isolated and stimulated for cytokine production. Peripheral blood mononuclear cells in the anakinra participants had decreased production of interferon-gamma, a proinflammatory cytokine, and significantly increased IL-22 production, the biggest differences. The authors noted in the patients treated with anakinra, the increase in IL-22 may have contributed to improvement in defense of the epithelial cells.
The main limitation of the study was the small population, but “despite the few enrolled patients, the results of anakinra use to treat HS are promising,” the authors concluded. Pointing out that anti–tumor necrosis factor (anti-TNF) therapy has been the most effective treatment for HS so far, they noted that “a major question that we cannot answer at this time is whether patients who show an insufficient response to anti-TNF treatment benefit from anakinra therapy.”
The study was supported by the Interleukin Foundation; the National Institutes of Health; the Hellenic Sepsis Study Group; and anakinra manufacturer, Swedish Orphan Biovitrum. One of the 10 authors, reported receiving grants and honoraria from pharmaceutical companies.