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J. Am. Acad. Dermatol. · Jan 2019
Randomized Controlled Trial Comparative StudyIxekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study.
- Carle Paul, Griffiths Christopher E M CEM Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom., van de Kerkhof Peter C M PCM Department of Dermatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands., Lluís Puig, Yves Dutronc, Carsten Henneges, Martin Dossenbach, Kristin Hollister, and Kristian Reich.
- Dermatology Department, CHU, Paul Sabatier University, Toulouse, France. Electronic address: paul.c@chu-toulouse.fr.
- J. Am. Acad. Dermatol. 2019 Jan 1; 80 (1): 70-79.e3.
BackgroundBiologics targeting interleukin 17A (IL-17A) allow for rapid clearance of psoriatic plaques, with a clinically favorable safety profile.ObjectivesTo compare the safety and efficacy of ixekizumab, an IL-17A antagonist, with the safety and efficacy of the IL-12/23 inhibitor ustekinumab through 52 weeks of treatment in the head-to-head trial IXORA-S.MethodsPatients were randomized to ixekizumab (n = 136) or ustekinumab (n = 166) and dosed per the approved labels. After 1 year, efficacy was assessed via improvements in Psoriasis Area and Severity Index (PASI) score (with PASI 90 indicating a 90% or greater improvement from baseline PASI score) and a static Physician's Global Assessment (sPGA) response of either 0 or 0 or 1, with dropouts counted as nonresponders. Safety analyses included treatment-emergent adverse events (AEs).ResultsAt week 52, significantly more ixekizumab-treated patients (P < .01) reported PASI 90 (104 [76.5%]), an sPGA response of 0 (72 [52.9%]), or an sPGA response of 0 or 1 (110 [82.1%]) responses than did ustekinumab-treated patients (PASI 90, 98 [59.0%]; sPGA response of 0, 60 [36.1%]; and sPGA response of 0 or 1, 108 [65.1%]). Treatment-emergent AEs, serious AEs, and discontinuation rates were not different between the treatment groups. Injection site reactions occurred more frequently in the ixekizumab-treated group (ixekizumab, 22 [16.3%]; ustekinumab, 2 [1.2%]) (P < .001).LimitationsThis study was not designed to compare safety end points related to rare events.ConclusionsCompared with ustekinumab, ixekizumab showed superior efficacy and comparable safety outcomes through 52 weeks of treatment.Copyright © 2018. Published by Elsevier Inc.
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