title: Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial.
abstract: BACKGROUND
  Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has shown superior efficacy to etanercept with similar safety in moderate to severe plaque psoriasis (FIXTURE study).
  
  
  OBJECTIVE
  We sought to directly compare efficacy and safety of secukinumab versus ustekinumab.
  
  
  METHODS
  In this 52-week, double-blind study (NCT02074982), 676 subjects were randomized 1:1 to subcutaneous injection of secukinumab 300 mg or ustekinumab per label. Primary end point was 90% or more improvement from baseline Psoriasis Area and Severity Index (PASI) score (PASI 90) at week 16.
  
  
  RESULTS
  Secukinumab (79.0%) was superior to ustekinumab (57.6%) as assessed by PASI 90 response at week 16 (P < .0001). The 100% improvement from baseline PASI score at week 16 was also significantly greater with secukinumab (44.3%) than ustekinumab (28.4%) (P < .0001). The 75% or more improvement from baseline PASI score at week 4 was superior for secukinumab (50.0%) versus ustekinumab (20.6%) (P < .0001). Percentage of subjects with the Dermatology Life Quality Index score 0/1 (week 16) was significantly higher with secukinumab (71.9%) than ustekinumab (57.4%) (P < .0001). The safety profile of secukinumab was comparable with ustekinumab and consistent with pivotal phase III secukinumab studies.
  
  
  CONCLUSIONS
  The study was not placebo-controlled and of short-term duration.
  
  
  CONCLUSIONS
  Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe psoriasis and improving health-related quality of life with a comparable safety profile over 16 weeks.
authors.affiliation: Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany. Electronic address: diamant.thaci@uksh.de.
authors.forename: Diamant
authors.initials: D
authors.lastname: Thaçi
authors.affiliation: Oregon Medical Research Center, Portland, Oregon.
authors.forename: Andrew
authors.initials: A
authors.lastname: Blauvelt
authors.affiliation: Dermatologikum Hamburg and Georg-August-University Göttingen, Göttingen, Germany.
authors.forename: Kristian
authors.initials: K
authors.lastname: Reich
authors.affiliation: National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Tsen-Fang
authors.initials: TF
authors.lastname: Tsai
authors.affiliation: Hospital 12 de Octubre, Av de Córdoba, Madrid, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Vanaclocha
authors.affiliation: Clinic of Dermatology, Tartu University Hospital, Department of Dermatology, University of Tartu, Tartu, Estonia.
authors.forename: Külli
authors.initials: K
authors.lastname: Kingo
authors.affiliation: Department of Dermatology, Ha'Emek Medical Center, Afula, Israel.
authors.forename: Michael
authors.initials: M
authors.lastname: Ziv
authors.affiliation: University of Frankfurt, Frankfurt, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Pinter
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Sophie
authors.initials: S
authors.lastname: Hugot
authors.affiliation: Beijing Novartis Pharma Co. Ltd, Shanghai, China.
authors.forename: Ruquan
authors.initials: R
authors.lastname: You
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Marina
authors.initials: M
authors.lastname: Milutinovic
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D011565:Psoriasis / Q000175:diagnosis / Q000188:drug therapy*; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome; D000069549:Ustekinumab / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C555450:secukinumab; D000069549:Ustekinumab
keywords: 90% or more improvement in baseline Psoriasis Area and Severity Index; clear or almost clear skin; clinical trial; head to head; plaque psoriasis; secukinumab; superiority; ustekinumab