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Original Investigation |

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

Vassiliki Tzanetakou, MD1; Theodora Kanni, MD1; Sophia Giatrakou, MD2; Alexandros Katoulis, MD, PhD2; Evangelia Papadavid, MD, PhD2; Mihai G. Netea, MD, PhD3; Charles A. Dinarello, MD, PhD3,4; Jos W. M. van der Meer, MD, PhD3; Dimitrios Rigopoulos, MD, PhD2; Evangelos J. Giamarellos-Bourboulis, MD, PhD1
[+] Author Affiliations
1Fourth Department of Internal Medicine, University of Athens Medical School, Athens, Greece
2Second Department of Dermatology and Venereology, University of Athens Medical School, Athens, Greece
3Department of Internal Medicine, Radboud University Medical Center, Nijmegen, the Netherlands
4Department of Medicine, University of Colorado, Denver
JAMA Dermatol. 2016;152(1):52-59. doi:10.1001/jamadermatol.2015.3903.
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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  clinicaltrials.gov Identifier: NCT01558375

Figures in this Article


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Figure 1.
CONSORT Diagram of the Flow of Study Participants

CONSORT indicates Consolidated Standards of Reporting Trials.

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Figure 2.
Change in Hidradenitis Suppurativa Severity Over Time

Patients with Hurley stage II or III hidradenitis suppurativa were randomized to placebo (n = 10) or anakinra (n = 9) for 12 weeks, followed by another 12 weeks of follow-up. The effect of anakinra treatment on disease severity was compared over the weeks of treatment and follow-up using the disease activity score, Sartorius score, visual analog scale (VAS) score, VAS score for pain, and Hidradenitis Suppurativa Clinical Response (HiSCR). P values are for comparisons between the 2 treatment arms. Only statistically significant differences are noted.

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Figure 3.
Time to a New Hidradenitis Suppurativa Exacerbation

Shown is a statistical comparison between placebo-treated patients and anakinra-treated patients.

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Figure 4.
Modulation of Cytokine Production

Shown are concentrations at week 0 (baseline), week 12 (the end of treatment), and week 24 (the end of follow-up). Peripheral blood mononuclear cells of patients randomized to placebo (n = 10) and to anakinra (n = 9) were isolated and stimulated with bacterial lipopolysaccharide (LPS), phytohemagglutin (PHA), and heat-killed isolates of Candida albicans (C albicans ) and of Staphylococcus aureus (S aureus). Only statistically significant differences are noted.

aP = .03 vs baseline.

bP = .046 vs baseline.

cP = .02 vs placebo.

dP = .04 vs placebo.

eP = .02 vs baseline.

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