Greater cumulative benefits from ixekizumab versus ustekinumab treatment over 52 weeks for patients with moderate-to-severe psoriasis in a randomized, double-blinded phase 3b clinical trial

J Dermatolog Treat. 2020 Mar;31(2):141-146. doi: 10.1080/09546634.2019.1587146. Epub 2019 Mar 18.

Abstract

Background: Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, has shown superiority to ustekinumab (UST) and etanercept in skin clearance from randomized clinical trials in patients with moderate-to-severe psoriasis.Objective: To compare cumulative benefits of IXE versus UST over 52 weeks of treatment.Methods: Cumulative clinical benefit of IXE and UST was assessed by evaluating the area under the curve (AUC) for responders of Psoriasis Area and Severity Index (PASI), itch numeric rating scale (Itch NRS), and Dermatology Life Quality Index (DLQI) outcomes over 52 weeks using data from IXORA-S trial comparing IXE (N = 136) and UST (N = 166). Normalized cumulative benefit was calculated to obtain the percentage of the maximum AUC for each outcome measure. Missing values were imputed using non-responder imputation.Results: Significantly greater cumulative benefits were obtained for IXE compared with UST. Normalized cumulative benefit with IXE versus UST for PASI 75/90/100, Itch NRS (0), and DLQI (0,1) were 83.1% and 67.6%; 68.9% and 46.5%; 41.1% and 23.4%; 40.4% and 30.9%; and 62.2% and 46.6%, respectively. Cumulative clinical benefit ratios for IXE:UST were 1.23 for PASI 75, 1.48 for PASI 90, and 1.76 for PASI 100, indicating an increase in the cumulative clinical benefit for IXE versus UST as the clearance levels increased.Conclusions: IXE showed greater cumulative clinical benefit than UST.

Keywords: Cumulative clinical benefits; interleukin-17A; ixekizumab; psoriasis; ustekinumab.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Area Under Curve
  • Dermatologic Agents / therapeutic use*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Male
  • Psoriasis / drug therapy*
  • Psoriasis / pathology
  • Quality of Life
  • ROC Curve
  • Severity of Illness Index
  • Treatment Outcome
  • Ustekinumab / therapeutic use*

Substances

  • Antibodies, Monoclonal, Humanized
  • Dermatologic Agents
  • ixekizumab
  • Ustekinumab