Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial

J Am Acad Dermatol. 2015 Sep;73(3):400-9. doi: 10.1016/j.jaad.2015.05.013. Epub 2015 Jun 17.

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.

Limitations: 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.

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.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Analysis of Variance
  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal, Humanized
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Injections, Subcutaneous
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Psoriasis / diagnosis
  • Psoriasis / drug therapy*
  • Reference Values
  • Risk Assessment
  • Severity of Illness Index
  • Treatment Outcome
  • Ustekinumab / administration & dosage*
  • Ustekinumab / adverse effects

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • secukinumab
  • Ustekinumab

Associated data

  • ClinicalTrials.gov/NCT02074982