title: Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data.
abstract: BACKGROUND
  Safety of biologics is important when treating patients with psoriasis.
  
  
  OBJECTIVE
  We sought to determine the safety of ixekizumab in psoriasis.
  
  
  METHODS
  Integrated safety data are presented from a 12-week induction period, a 12- to 60-week maintenance period, and from all ixekizumab-treated patients from 7 clinical trials. Exposure-adjusted incidence rates (IRs) per 100 patient-years are reported.
  
  
  RESULTS
  Overall, 4209 patients received ixekizumab (total exposure: 6480 patient-years). During the induction period, the IRs of patients experiencing 1 or more treatment-emergent adverse event (AE) were 251 and 236 among ixekizumab- and etanercept-treated patients, respectively, and for serious AEs was 8.3 in both groups. During maintenance, for ixekizumab, the IRs of treatment-emergent AEs and serious AEs were 100.4 and 7.8, respectively. Among all ixekizumab-treated patients from 7 trials, the IR of Candida infections was 2.5. The IRs of treatment-emergent AEs of special interest (including serious infections, malignancies, major adverse cardiovascular events) were comparable for ixekizumab and etanercept during the induction period.
  
  
  CONCLUSIONS
  Additional long-term data are required.
  
  
  CONCLUSIONS
  Ixekizumab had an acceptable safety profile with no unexpected safety findings during ixekizumab maintenance in psoriasis.
authors.affiliation: Department of Dermatology, University of Connecticut Health Center and Probity Medical Research, Farmington, Connecticut. Electronic address: strober@uchc.edu.
authors.forename: Bruce
authors.initials: B
authors.lastname: Strober
authors.affiliation: Central Dermatology PC, St Louis, Missouri.
authors.forename: Craig
authors.initials: C
authors.lastname: Leonardi
authors.affiliation: K. Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada.
authors.forename: Kim A
authors.initials: KA
authors.lastname: Papp
authors.affiliation: Psoriasis-Center, University Medical Center Schleswig-Holstein, Campus Kiel, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Mrowietz
authors.affiliation: Jichi Medical University, Shimotsuke, Tochigi, Japan.
authors.forename: Mamitaro
authors.initials: M
authors.lastname: Ohtsuki
authors.affiliation: Innovaderm Research, Montreal, Canada.
authors.forename: Robert
authors.initials: R
authors.lastname: Bissonnette
authors.affiliation: Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Laura K
authors.initials: LK
authors.lastname: Ferris
authors.affiliation: Dermatology, Paul Sabatier University, Toulouse, France.
authors.forename: Carle
authors.initials: C
authors.lastname: Paul
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Mark
authors.initials: M
authors.lastname: Lebwohl
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Daniel K
authors.initials: DK
authors.lastname: Braun
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Lotus
authors.initials: L
authors.lastname: Mallbris
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Stefan
authors.initials: S
authors.lastname: Wilhelm
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Wen
authors.initials: W
authors.lastname: Xu
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Anders
authors.initials: A
authors.lastname: Ljungberg
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Nayan
authors.initials: N
authors.lastname: Acharya
authors.affiliation: Dermatologikum Hamburg and SCIderm, Hamburg, Germany.
authors.forename: Kristian
authors.initials: K
authors.lastname: Reich
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects*; D002177:Candidiasis / Q000139:chemically induced / Q000453:epidemiology*; D002986:Clinical Trials as Topic; D003093:Colitis, Ulcerative / Q000139:chemically induced / Q000453:epidemiology; D003424:Crohn Disease / Q000139:chemically induced / Q000453:epidemiology; D003879:Dermatologic Agents / Q000009:adverse effects*; D000068800:Etanercept / Q000009:adverse effects*; D005260:Female; D006801:Humans; D015994:Incidence; D060828:Induction Chemotherapy / Q000009:adverse effects; D060046:Maintenance Chemotherapy / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000139:chemically induced / Q000453:epidemiology; D009369:Neoplasms / Q000139:chemically induced / Q000453:epidemiology*; D011565:Psoriasis / Q000188:drug therapy*; D020521:Stroke / Q000139:chemically induced / Q000453:epidemiology; D013997:Time Factors
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; C549079:ixekizumab; D000068800:Etanercept
keywords: adverse events; etanercept; integrated analysis; interleukin-17A; ixekizumab; psoriasis; safety