title: Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: double-blind, randomized controlled trial and open-label extension study.
abstract: BACKGROUND
  Tumor necrosis factor is pivotal in the pathogenesis of psoriasis. Adalimumab is a fully human monoclonal immunoglobulin G1 antibody that neutralizes tumor necrosis factor.
  
  
  OBJECTIVE
  We sought to assess the efficacy and safety of adalimumab in patients with moderate to severe plaque psoriasis.
  
  
  METHODS
  In this multicenter, randomized, double-blind, placebo-controlled study, 147 patients received adalimumab (40 mg every other week or 40 mg/wk) or placebo. After 12 weeks of blinded therapy, patients taking adalimumab could continue their assigned dosages in a 48-week extension trial; patients taking placebo were switched to adalimumab (40 mg every other week).
  
  
  RESULTS
  At week 12, 53% of patients taking adalimumab every other week, 80% of patients taking adalimumab weekly, and 4% of patients taking placebo achieved 75% improvement in Psoriasis Area and Severity Index score (P < .001). Responses were sustained for 60 weeks. No new safety signals were noted compared with the existing adalimumab clinical safety database.
  
  
  CONCLUSIONS
  The study was insufficiently powered to detect rare adverse events associated with adalimumab.
  
  
  CONCLUSIONS
  Adalimumab significantly improved psoriasis and was well tolerated for 60 weeks.
authors.affiliation: Division of Dermatology, Evanston Northwestern Healthcare and Northwestern University Feinberg School of Medicine, Skokie, IL 60077, USA. kgordon@enh.org
authors.forename: Kenneth B
authors.initials: KB
authors.lastname: Gordon
authors.forename: Richard G
authors.initials: RG
authors.lastname: Langley
authors.forename: Craig
authors.initials: C
authors.lastname: Leonardi
authors.forename: Darryl
authors.initials: D
authors.lastname: Toth
authors.forename: M Alan
authors.initials: MA
authors.lastname: Menter
authors.forename: Sewon
authors.initials: S
authors.lastname: Kang
authors.forename: Michael
authors.initials: M
authors.lastname: Heffernan
authors.forename: Bruce
authors.initials: B
authors.lastname: Miller
authors.forename: Regina
authors.initials: R
authors.lastname: Hamlin
authors.forename: Liberata
authors.initials: L
authors.lastname: Lim
authors.forename: Jianhua
authors.initials: J
authors.lastname: Zhong
authors.forename: Rebecca
authors.initials: R
authors.lastname: Hoffman
authors.forename: Martin M
authors.initials: MM
authors.lastname: Okun
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000068879:Adalimumab