title: Adalimumab Treatment in Women With Moderate-to-Severe Hidradenitis Suppurativa from the Placebo-Controlled Portion of a Phase 2, Randomized, Double-Blind Study.
abstract: BACKGROUND
  Hidradenitis Suppurativa (HS), also known as acne inversa, is a painful, chronic, debilitating, inflammatory skin disease and has shown response to anti-TNF-α therapy. Efficacy and safety of the anti-TNF-α agent, adalimumab, was assessed in a post hoc analysis of women from the first 16 weeks of a phase 2 study of men and women with HS.
  
  
  METHODS
  Patients with moderate-to-severe HS in at least 2 body areas, unresponsive or intolerant to oral antibiotics for treatment of their HS, and with no previous anti-TNF-a or systemic non-biologic treatment, were randomized 1:1:1 to 40 mg adalimumab-weekly or every-other-week, or placebo. Efficacy was analyzed post hoc for women from the intent-to-treat population (ITT Population). Efficacy was analyzed for the primary endpoint Hidradenitis Suppurativa Physicians Global Response Clinical Response (HS-PGA Clinical Response), Hidradenitis Suppurativa Clinical Response (HiSCR, defined as a ≥50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to baseline), and a pain endpoint, represented by 30% reduction measured by visual analog scale (VAS30).
  
  
  RESULTS
  At week 16, a higher percentage of women randomized to adalimumab-weekly vs. every-other-week or placebo achieved treatment response measured by HS-PGA (19.4% vs. 7.9% or 5.6%; P>.05), by HiSCR (51.6% vs. 24.2% or 27.6%; P>.05), and achieved VAS30 (50.0% vs. 34.3%; P>.05 or 21.2% P<.05; significant for adalimumab-weekly vs. placebo). Four women had serious adverse events (anemia, benign neoplasm, pneumonia, and suicide attempt). There were no fatalities. Women had a similarly acceptable safety profile as the overall study population.
  
  
  CONCLUSIONS
  In this subpopulation of women with moderate-to-severe HS, a greater proportion achieved reduction in HS severity and pain with adalimumab 40 mg weekly dosing compared with every-other-week or placebo. No new safety signals were identified. <br /><br /> <em>J Drugs Dermatol.</em> 2016;15(10):1192-1196.
authors.forename: Alice
authors.initials: A
authors.lastname: Gottlieb
authors.forename: Alan
authors.initials: A
authors.lastname: Menter
authors.forename: April
authors.initials: A
authors.lastname: Armstrong
authors.forename: Christopher
authors.initials: C
authors.lastname: Ocampo
authors.forename: Yihua
authors.initials: Y
authors.lastname: Gu
authors.forename: Henrique D
authors.initials: HD
authors.lastname: Teixeira
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage*; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D017497:Hidradenitis Suppurativa / Q000175:diagnosis* / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D000068879:Adalimumab