A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa

Hidradenitis suppurativa Research

Author(s): Miller I, Lynggaard CD, Lophaven S, Zachariae C, Dufour DN, Jemec GB

BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients’ quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed.

OBJECTIVES: To test the efficacy of adalimumab in HS.

METHODS: This was a prospective, randomized, double-blinded, placebo-controlled, two-centre clinical trial conducted in Denmark. Inclusion criteria were age above 18 years and a clinical diagnosis of moderate to severe HS defined as Hurley stage II or III for at least 6 months. The patients were randomized 1:2 (placebo/active). Actively treated patients received adalimumab 80 mg subcutaneously (s.c.) at baseline followed by 40 mg s.c. every other week for 12 weeks. Placebo-treated patients received identical-looking injections with no active ingredient. The medicine was dispensed in sequentially numbered computer-randomized containers. Participants, care givers and those assessing the outcomes were blinded to group assignment. The primary efficacy endpoints were changes in the HS scores (Sartorius and Hurley scoring systems). Secondary efficacy endpoints included changes in pain (visual analogue scale), days with lesions and Dermatology Life Quality Index, and evaluation of scarring. Recruitment was terminated early due to expiry date of trial medication.

RESULTS: Twenty-one patients were included, of whom 15 received adalimumab and six received placebo. All participants were analysed according to the intention to treat principle. A significant reduction was seen in Sartorius score after 6 weeks and an almost significant reduction was seen after 12 weeks of active treatment (-10·7 vs. 7·5, P = 0·024 and -11·3 vs. 5·8, P = 0·07) when compared with the placebo group.

CONCLUSIONS: A significant reduction in HS severity was gained after 6 weeks. No long-term curative effect was uniformly seen.

Dermatology Journal and/or Publisher

Journal Name: The British journal of dermatology
Journal Abbreviation: Br. J. Dermatol.
Journal Date Published: 2011-07-22

National Center for Biotechnology Information

PMID: 21457202
Article Source: http://www.ncbi.nlm.nih.gov/pubmed/21457202
Lasted Revision: 2015-11-19

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


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