Long-term efficacy and safety of ixekizumab: A 5-year analysis of the UNCOVER-3 randomized controlled trial
Andrew Blauvelt, Mark G Lebwohl, Tomotaka Mabuchi, Ann Leung, Alyssa Garrelts, Heidi Crane, Hany ElMaraghy, Himanshu Patel, Terri Ridenour, Kyoungah See, Gaia Gallo, Carle Paul, Andrew Blauvelt, Mark G Lebwohl, Tomotaka Mabuchi, Ann Leung, Alyssa Garrelts, Heidi Crane, Hany ElMaraghy, Himanshu Patel, Terri Ridenour, Kyoungah See, Gaia Gallo, Carle Paul
Abstract
Objective: To report the efficacy and safety of the approved ixekizumab (IXE) dose over 5 years from UNCOVER-3 (NCT01646177).
Methods: 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.
Results: 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).
Limitations: Lack of comparison treatment group after week 12.
Conclusion: IXE demonstrates sustained efficacy and consistent safety through 264 weeks in patients using the approved dose.
Keywords: UNCOVER-3; efficacy; ixekizumab; long-term; psoriasis; safety.
Conflict of interest statement
Conflicts of interest Dr Blauvelt has served as a scientific advisor and/or clinical study investigator for AbbVie, Aclaris, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly and Company, Forte, Galderma, Janssen, Leo, Novartis, Ortho, Pfizer, Rapt, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, and UCB Pharma and as a paid speaker for AbbVie. Dr Lebwohl is an employee of Mount Sinai; receives research funds from AbbVie, Amgen, Arcutis, AstraZeneca, Boehringer Ingelheim, Celgene, Clinuvel, Eli Lilly, Incyte, Janssen Research and Development, LLC, Kadmon Corp, LLC, Leo Pharmaceuticals, MedImmune, Novartis, Ortho Dermatologics, Pfizer, Sciderm, UCB, and Vida; and is a consultant for Allergan, Almirall, Arcutis, Inc, Avotres Therapeutics, BirchBioMed Inc, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Evelo, Foundation for Research and Education in Dermatology, Inozyme Pharma, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi, Neuroderm, Pfizer, Promius/Dr. Reddy's Laboratories, Theravance, and Verrica. Dr Mabuchi has served as a paid speaker for Eli Lilly, Maruho, Kyowa Kirin, Celgene, and Janssen and has received research funds from Kyowa Kirin, Torii, Maruho, Taiho, and Leo Pharma. Author Leung is an employee of Syneos Health, on behalf of Eli Lilly. Dr Garrelts, Author Crane, Drs ElMaraghy and Patel, Author Ridenour, and Drs See and Gallo are employees of Eli Lilly and Company and own stock. Dr Paul is a consultant and investigator for Amgen, AbbVie, Almirall, Boehringer Ingelheim, Celgene, Dermira, Janssen-Cilag, Leo Pharma, Eli Lilly and Company, GlaxoSmithKline, Novartis, Pfizer, Pierre Fabre, Regeneron, Sanofi Genzyme, and UCB Pharma.
Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
Source: PubMed