title: A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa.
abstract: BACKGROUND
  Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed.
  
  
  OBJECTIVE
  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.
authors: Department of Dermatology, Roskilde Hospital, Health Sciences Faculty, University of Copenhagen, Roskilde 4000, Denmark. miller@dadlnet.dk
authors: I
authors: I
authors: Miller
authors: C D
authors: CD
authors: Lynggaard
authors: S
authors: S
authors: Lophaven
authors: C
authors: C
authors: Zachariae
authors: D N
authors: DN
authors: Dufour
authors: G B E
authors: GB
authors: Jemec
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D004311:Double-Blind Method; D005260:Female; D017497:Hidradenitis Suppurativa / Q000188:drug therapy*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000517:prevention & control; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000068879:Adalimumab