Safety and Efficacy of Anakinra in Severe Hidradenitis Suppurativa: A Randomized Clinical Trial

Hidradenitis suppurativa Research

Author(s): Tzanetakou V, Kanni T, Giatrakou S, Katoulis A, Papadavid E, Netea MG, Dinarello CA, van der Meer JWM, Rigopoulos D, Giamarellos-Bourboulis EJ

IMPORTANCE: Hidradenitis suppurativa (HS) is a common skin disorder in which excessive inflammation is believed to have an important role. There is no specific therapy for HS.

OBJECTIVE: To investigate the safety and efficacy of the anti-inflammatory biological therapy anakinra in HS.

DESIGN, SETTING, AND PARTICIPANTS: Double-blind, randomized, placebo-controlled clinical trial with a 12-week treatment phase and a 12-week follow-up phase. The setting was Attikon University General Hospital, a tertiary care institution in Athens, Greece. Participants were 20 patients with Hurley stage II or III HS. The study and the analysis were conducted between March 1, 2012, and February 28, 2014.

INTERVENTIONS: Patients were randomized to receive injections from identical syringes containing placebo or anakinra subcutaneously once daily for 12 weeks. Peripheral blood mononuclear cells were isolated and stimulated for cytokine production before the beginning of treatment and at week 12 (the end of treatment) and week 24.

MAIN OUTCOMES AND MEASURES: The primary end point was the effect of anakinra on HS disease severity. Secondary end points were the time to a new exacerbation and the production of cytokines.

RESULTS: Among the 20 trial participants, 10 each were randomized to the group to receive anakinra or the placebo group. The mean (SD) ages were 42.8 (13.8) and 36 (11.3) years in the anakinra and placebo groups, respectively. The disease activity score was decreased at the end of treatment in 20% (2 of 10) of the placebo arm compared with 67% (6 of 9) of the anakinra arm (P = .04). Hidradenitis suppurativa clinical response at 12 weeks was achieved in 30% (3 of 10) of the placebo arm and in 78% (7 of 9) of the anakinra arm (P = .04). The production of interferon-γ by peripheral blood mononuclear cells in the anakinra arm was decreased, and the production of interleukin 22 was increased. The time to a new HS exacerbation was prolonged in the anakinra arm by log-rank test (log rank, 6.137; P = .01). No serious adverse events were reported.

CONCLUSIONS AND RELEVANCE: Anakinra has the potential to be an effective and well-tolerated treatment for HS. Inhibition of interleukin 1 is a promising treatment strategy.

TRIAL REGISTRATION: Identifier: NCT01558375.

Dermatology Journal and/or Publisher

Journal Name: JAMA dermatology
Journal Abbreviation: JAMA Dermatol
Journal Date Published: 2016-01-14

National Center for Biotechnology Information

PMID: 26579854
Article Source:
Lasted Revision: 2017-08-09

Abstract Source: National Center for Biotechnology Information, U.S. National Library of Medicine Abstract Query for Hidradenitis suppurativa (HS).


Leave a reply

HSAWARENESS.ORG | Fighting for Hidradenitis suppurativa (HS), a.k.a Acne Inversa Patient and Doctor Awareness ©2019  All Rights Reserved. Your use of this website constitutes explicit agreement to our Terms of Use and Privacy Policies. This website does not provide medical advice, diagnosis or treatment.

Log in with your credentials

Forgot your details?