Tildrakizumab vs. Placebo or Etanercept for Chronic Plaque Psoriasis



Title: Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials

Reich, K et al.


 

What You Need to Know:

According to results of two phase 3 trials, reSURFACE 1 and 2, 100mg and 200mg of tildrakizumab were more efficacious than placebo and etanercept in the treatment of moderate-severe chronic plaque psoriasis.

Trial Design:

  • Three-part, multicenter, double-blind, parallel-group, phase 3 studies compared tildrakizumab to placebo and etanercept for the treatment of moderate-to-severe chronic plaque psoriasis
  • reSURFACE 1: patients were randomized (2:2:1) to 200mg tildrakizumab, 100mg tildrakizumab, or placebo
  • reSURFACE 2: patients were randomized (2:2:1:2) to 200mg tildrakizumab, 100mg tildrakizumab, placebo, or 50mg etanercept
  • “Tildrakizumab was administered subcutaneously at weeks 0 and 4 during part 1 and at week 16 during part 2 (weeks 12 and 16 for participants re-randomised from placebo to tildrakizumab; etanercept was given twice weekly in part 1 of reSURFACE 2 and once weekly during part 2)”
  • Coprimary endpoints: proportion of patients attaining Psoriasis Area and Severity Index (PASI) 75 and Physician's Global Assessment (PGA) response at week 12
  • Efficacy assessed using full-analysis set; safety assessed in all-participants-as-treated population

Key Outcomes:

  • reSURFACE 1: 62% of 200-mg tildrakizumab patients (192/308) and 64% of 100-mg tildrakizumab patients (197/309) achieved PASI 75 at week 12 vs 6% of placebo patients (9/155) (P<0.0001 for both comparisons)
  • reSURFACE 1: 59% of 200-mg tildrakizumab patients (182/308) and 58% of 100-mg tildrakizumab patients (179/309) achieved PGA responses vs 7% of placebo patients (11/155) (P<0.0001 for both comparisons)
  • reSURFACE 2: 66% of 200-mg tildrakizumab patients (206/314) and 61% of 100-mg tildrakizumab patients (188/307) achieved PASI 75 at week 12 vs 6% of placebo patients (9/156) and 48% of etanercept patients (151/313) (P<0.0001 for tildrakizumab vs placebo and 200mg tildrakizumab vs etanercept comparisons; P=0.0010 for 100mg tildrakizumab vs etanercept)
  • reSURFACE 2: 59% of 200-mg tildrakizumab patients (186/314) and 55% of 100-mg tildrakizumab patients (168/307) achieved PGA responses vs 4% of placebo patients (7/156) and 48% of etanercept patients (149/313) (P<0.0001 for tildrakizumab vs placebo comparisons; P=0.0031 for 200mg tildrakizumab vs etanercept; P=0.0663 for 100mg tildrakizumab vs etanercept)
  • Serious adverse events: similar among groups; low rates overall
  • 1 death occurred during reSURFACE 2; cause of death could not be determined