title: Treatment outcomes with ixekizumab in patients with moderate-to-severe psoriasis who have or have not received prior biological therapies: an integrated analysis of two Phase III randomized studies.
abstract: BACKGROUND
  Biologics are effective for the treatment of psoriasis. However, treatment outcomes may differ among biologic-naive patients and those switched from previous biological therapies.
  
  
  OBJECTIVE
  The study's objective was to investigate efficacy and safety of ixekizumab, a high-affinity anti-interleukin-17A antibody, in patients with psoriasis with and without previous exposure to biologics.
  
  
  METHODS
  Data were integrated from the 12-week induction phase of two etanercept-controlled Phase III trials. Patients received 80 mg ixekizumab every 2 weeks (IXE Q2W; N = 736) or every 4 weeks (IXE Q4W; N = 733) following a 160-mg starting dose, or placebo (N = 361). Etanercept (50 mg twice weekly; N = 740) was administered as active control. Psoriasis Area and Severity Index (PASI) 75, PASI 90 and PASI 100 response rates at week 12 were evaluated in patients with or without previous exposure to biologics. Treatment effects were analysed with the Cochran-Mantel-Haenszel test stratified by study; missing values were imputed as non-response.
  
  
  RESULTS
  Overall, 497 (19.3%) patients had prior exposure to biologics and 2073 (80.7%) were naive to biologic therapy. PASI 75 was achieved by 91.5% of biologic-experienced patients and 87.7% of biologic-naive patients for IXE Q2W, 76.2% and 82.2% for IXE Q4W, respectively, and 34.6% and 50.7%, respectively, for etanercept. Higher response rates favouring each ixekizumab dose over etanercept within subgroups were also seen regarding PASI 90 and PASI 100.
  
  
  CONCLUSIONS
  Contrary to etanercept, the efficacy of ixekizumab was similarly high in patients with and without previous exposure to biologics when administered 80 mg every 2 weeks.
authors.affiliation: Department of Dermatology, New York Medical College, Valhalla, NY, USA.
authors.forename: A B
authors.initials: AB
authors.lastname: Gottlieb
authors.affiliation: Department of Dermatology, University Hospital of Nice, Nice, France.
authors.forename: J-P
authors.initials: JP
authors.lastname: Lacour
authors.affiliation: Murdough Family Center for Psoriasis, University Hospitals Case Medical Center, Cleveland, OH, USA.
authors.forename: N
authors.initials: N
authors.lastname: Korman
authors.affiliation: Global Medical Affairs, Lilly Deutschland GmbH, Bad Homburg, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Wilhelm
authors.affiliation: Regional Medical Affairs, Lilly France, Neuilly-sur-Seine, France.
authors.forename: Y
authors.initials: Y
authors.lastname: Dutronc
authors.affiliation: Global Medical Affairs, Lilly Deutschland GmbH, Bad Homburg, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Schacht
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: J
authors.initials: J
authors.lastname: Erickson
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: L
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: L
authors.initials: L
authors.lastname: Mallbris
authors.affiliation: Department of Dermatology, Psoriasis-Center, University Medical Center Schleswig-Holstein, Kiel, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Gerdes
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D057915:Drug Substitution; D000068800:Etanercept / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011565:Psoriasis / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D063189:Symptom Assessment; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; C549079:ixekizumab; D000068800:Etanercept