title: A 52-week, open-label study of the efficacy and safety of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with chronic plaque psoriasis.
abstract: BACKGROUND
  Patients with moderate to severe plaque psoriasis demonstrated positive responses to ixekizumab, an anti-interleukin-17A monoclonal antibody, in a phase-II, randomized, placebo-controlled trial.
  
  
  OBJECTIVE
  We sought to evaluate long-term efficacy and safety of ixekizumab.
  
  
  METHODS
  After receiving 10, 25, 75, or 150 mg of ixekizumab or placebo during randomized, placebo-controlled trial, patients with less than 75% improvement from baseline on the Psoriasis Area and Severity Index (PASI) score (PASI75) entered open-label extension (OLE); patients with PASI75 or higher entered a treatment-free period (weeks 20-32), then entered OLE after meeting response criteria. During OLE, patients received 120 mg of subcutaneous ixekizumab every 4 weeks.
  
  
  RESULTS
  In all, 120 patients entered OLE; 103 completed 52 weeks or more of treatment. Overall, 77% of patients achieved PASI75 at week 52 (nonresponder imputation). Patients who responded to treatment in the randomized, placebo-controlled trial maintained a high-level response by week 52 of OLE (PASI75 = 95%; 90% improvement from baseline on the PASI score = 94%; 100% improvement from baseline on the PASI score = 82%). Irrespective of dose in the randomized, placebo-controlled trial, each group had similar response rates at week 52 of OLE. The exposure-adjusted incidence rate for adverse events was 0.47 and for serious adverse events was 0.06 per patient-year during OLE.
  
  
  CONCLUSIONS
  No control group, small sample sizes, and bias toward retention of patients with positive responses limit interpretation.
  
  
  CONCLUSIONS
  A high proportion of patients responded to ixekizumab therapy and maintained clinical responses over 1 year of treatment with no unexpected safety signals.
authors.affiliation: Northwestern University, Feinberg School of Medicine, Chicago, Illinois. Electronic address: kenneth-gordon@northwestern.edu.
authors.forename: Kenneth B
authors.initials: KB
authors.lastname: Gordon
authors.affiliation: Saint Louis University School of Medicine, St Louis, Missouri.
authors.forename: Craig L
authors.initials: CL
authors.lastname: Leonardi
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Mark
authors.initials: M
authors.lastname: Lebwohl
authors.affiliation: Oregon Medical Research Center, Portland, Oregon.
authors.forename: Andrew
authors.initials: A
authors.lastname: Blauvelt
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Cameron
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Daniel
authors.initials: D
authors.lastname: Braun
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Janelle
authors.initials: J
authors.lastname: Erickson
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Michael
authors.initials: M
authors.lastname: Heffernan
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects*; D002908:Chronic Disease; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D020381:Interleukin-17 / Q000037:antagonists & inhibitors* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy* / Q000276:immunology; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; C508717:IL17A protein, human; D020381:Interleukin-17; C549079:ixekizumab
keywords: 1 year; interleukin 17; ixekizumab; long-term; monoclonal antibodies; open label; psoriasis