title: Secukinumab in psoriasis: randomized, controlled phase 3 trial results assessing the potential to improve treatment response in partial responders (STATURE).
abstract: BACKGROUND
  Secukinumab, an anti-interleukin-17A monoclonal antibody, has demonstrated rapid and sustained efficacy in phase 3 psoriasis trials.
  
  
  OBJECTIVE
  To examine whether partial responders could achieve improved responses with intravenous (IV) secukinumab vs. the same or a higher subcutaneous (SC) dose.
  
  
  METHODS
  Forty-three participants with moderate-to-severe psoriasis and partial response [Psoriasis Area and Severity Index (PASI) score improvement of ≥ 50% but < 75%] after 12 weeks of 300 or 150 mg SC secukinumab therapy were randomized 1 : 1 to secukinumab 10 mg kg(-1) IV (baseline, weeks 2 and 4, respectively) or secukinumab 300 mg SC (baseline, week 4). All participants subsequently received secukinumab 300 mg SC every 4 weeks (weeks 8-36). Co-primary end points were PASI 75 and Investigator's Global Assessment [2011 modified version (IGA mod 2011)] 0/1 response rates at week 8 (IV vs. SC).
  
  
  RESULTS
  Higher IGA mod 2011 0/1 response rates (66.7% vs. 33.3%; P = 0.03) and a trend towards higher PASI 75 response rates (90.5% vs. 66.7%; P = 0.06) were observed with secukinumab IV vs. SC at week 8. The primary objective was not met, as the difference was not significant for both co-primary end points. Improved responses in both groups were maintained at week 40 in most participants. Safety profiles for IV and SC secukinumab were similar. The trial was underpowered owing to its small sample size.
  
  
  CONCLUSIONS
  Improved response may be attained in patients with psoriasis achieving partial response after 12 weeks of SC secukinumab treatment by continued dosing with 300 mg SC or treatment with higher doses.
authors.affiliation: Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, 23538, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Thaçi
authors.affiliation: Humeniuk Dermatology, Greenville, SC, U.S.A.
authors.forename: J
authors.initials: J
authors.lastname: Humeniuk
authors.affiliation: Hanse-Klinik, Lübeck, Germany.
authors.forename: Y
authors.initials: Y
authors.lastname: Frambach
authors.affiliation: Innovaderm Research, Montreal, QC, Canada.
authors.forename: R
authors.initials: R
authors.lastname: Bissonnette
authors.affiliation: Palm Beach Research Center, West Palm Beach, FL, U.S.A.
authors.forename: J J
authors.initials: JJ
authors.lastname: Goodman
authors.affiliation: Novartis Healthcare Private Limited, Hyderabad, India.
authors.forename: S
authors.initials: S
authors.lastname: Shevade
authors.affiliation: Beijing Novartis Pharma Co. Ltd., Shanghai, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Gong
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: C
authors.initials: C
authors.lastname: Papavassilis
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; C555450:secukinumab