An open-label study of anakinra for the treatment of moderate to severe hidradenitis suppurativa

J Am Acad Dermatol. 2014 Feb;70(2):243-51. doi: 10.1016/j.jaad.2013.09.044. Epub 2013 Dec 4.


Background: Hidradenitis suppurativa (HS) is a chronic inflammatory disorder characterized by sterile abscesses and fistulae predominantly affecting the axillae and groin. Various biologic agents have been attempted for HS, but there is still no definitive treatment.

Objectives: We sought to evaluate the efficacy, safety, and tolerability of anakinra in the treatment of moderate to severe HS.

Methods: Six patients with moderate to severe HS were enrolled in an open-label study with all patients receiving active treatment for 8 weeks with an additional 8 weeks of follow-up off therapy.

Results: The 5 patients who completed the 8-week therapy showed a significant mean decrease in their modified Sartorius score of 34.8 points. The physician and patient global assessment of overall activity showed significant reductions between baseline and 8 weeks of therapy: 45.8 points and 35.6 points, respectively. The Dermatology Life Quality Index showed a significant reduction after 8 weeks of treatment with anakinra. Functional T-cell analysis revealed that patients had increased percentages of CD3(+) T cells in lesional skin compared with nonlesional skin before therapy.

Limitations: The limited number of patients and lack of control group are limitations.

Conclusions: Anakinra demonstrated decreased HS disease activity by both objective and subjective measures.

Keywords: CI; DLQI; Dermatology Life Quality Index; HS; IL; T cells; TNF; Th; VAS; anakinra; confidence interval; helper T cell; hidradenitis suppurativa; inflammation; interleukin; interleukin-1; treatment; tumor necrosis factor; visual analog scale.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Hidradenitis Suppurativa / diagnosis*
  • Hidradenitis Suppurativa / drug therapy*
  • Humans
  • Injections, Subcutaneous
  • Interleukin 1 Receptor Antagonist Protein / administration & dosage*
  • Male
  • Patient Satisfaction / statistics & numerical data
  • Pilot Projects
  • Prospective Studies
  • Quality of Life*
  • Severity of Illness Index
  • Treatment Outcome


  • Interleukin 1 Receptor Antagonist Protein