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Long-term efficacy and safety of ixekizumab: A 5-year analysis of the UNCOVER-3 randomized controlled trial.

Authors
  • Blauvelt, Andrew1
  • Lebwohl, Mark G2
  • Mabuchi, Tomotaka3
  • Leung, Ann4
  • Garrelts, Alyssa5
  • Crane, Heidi5
  • ElMaraghy, Hany5
  • Patel, Himanshu5
  • Ridenour, Terri5
  • See, Kyoungah5
  • Gallo, Gaia5
  • Paul, Carle6
  • 1 Oregon Medical Research Center, Portland, Oregon. Electronic address: [email protected]
  • 2 Icahn School of Medicine at Mount Sinai, New York, New York.
  • 3 Tokai University School of Medicine, Kanagawa, Japan. , (Japan)
  • 4 Syneos Health, Morrisville, North Carolina.
  • 5 Eli Lilly and Company, Indianapolis, Indiana. , (India)
  • 6 Toulouse University and Larrey Hospital, Toulouse, France. , (France)
Type
Published Article
Journal
Journal of the American Academy of Dermatology
Publication Date
Aug 01, 2021
Volume
85
Issue
2
Pages
360–368
Identifiers
DOI: 10.1016/j.jaad.2020.11.022
PMID: 33253833
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

To report the efficacy and safety of the approved ixekizumab (IXE) dose over 5 years from UNCOVER-3 (NCT01646177). Patients (N = 1346) were randomized 1:2:2:2 to receive subcutaneous injections of placebo, etanercept 50 mg twice weekly, or IXE 80 mg every 2 weeks or every 4 weeks after an initial dose of IXE 160 mg, respectively. At week 12, patients entered the long-term extension period with dosing of IXE every 4 weeks and could escalate to every 2 weeks after week 60. Efficacy was reported for the IXE every 2 weeks/every 4 weeks group of the intent-to-treat population. Safety was reported for patients who received at least 1 dose of IXE every 2 or every 4 weeks. Using modified nonresponder imputation, 78.8%/67.1%/46.2% of patients receiving the approved dose of IXE every 2 weeks/every 4 weeks (n = 385) achieved ≥75%, ≥90%, or 100% improvement from baseline in the Psoriasis Area and Severity Index, respectively, at week 264; static Physician's Global Assessment score of 0/1 and 0 responses were 69.2% and 45.3%, respectively. Infections were the most observed treatment-emergent adverse event (72.7% of patients). Lack of comparison treatment group after week 12. IXE demonstrates sustained efficacy and consistent safety through 264 weeks in patients using the approved dose. Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

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