Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study.

Abstract

BACKGROUND:

Biologics targeting interleukin 17A (IL-17A) allow for rapid clearance of psoriatic plaques, with a clinically favorable safety profile.

OBJECTIVES:

To 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.

METHODS:

Patients 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).

RESULTS:

At 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).

LIMITATIONS:

This study was not designed to compare safety end points related to rare events.

CONCLUSIONS:

Compared with ustekinumab, ixekizumab showed superior efficacy and comparable safety outcomes through 52 weeks of treatment.

• Authors: Carle Paul, Christopher E M Griffiths, Peter C M van de Kerkhof, Lluís Puig, Yves Dutronc, Carsten Henneges, Martin Dossenbach, Kristin Hollister, Kristian Reich
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 80 Issue 1 Pg. 70-79.e3 (Jan 2019) ISSN: 1097-6787 [Electronic] United States
• PMID: 29969700 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2018. Published by Elsevier Inc.

Chemical References

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

Topics

• Adult
• Antibodies, Monoclonal, Humanized (administration & dosage)
• Dermatologic Agents (administration & dosage)
• Double-Blind Method
• Female
• Humans
• Male
• Psoriasis (drug therapy)
• Time Factors
• Treatment Outcome
• Ustekinumab (administration & dosage)