Comparison of ixekizumab with ustekinumab in moderate-to-severe psoriasis: 24-week results from IXORA-S, a phase III study
Top Cited Papers
Open Access
- 19 July 2017
- journal article
- research article
- Published by Oxford University Press (OUP) in British Journal of Dermatology
- Vol. 177 (4), 1014-1023
- https://doi.org/10.1111/bjd.15666
Abstract
It has been shown that the interleukin (IL)‐23/IL‐17 axis is critical in the pathogenesis of psoriasis. To present the primary end point (week 12) and safety and efficacy data up to week 24 from a head‐to‐head trial (IXORA‐S) of the IL‐17A inhibitor ixekizumab (IXE) vs. the IL‐12/23 inhibitor ustekinumab (UST). Randomized patients received IXE (160‐mg starting dose, then 80 mg every 2 weeks for 12 weeks, then 80 mg every 4 weeks, n = 136) or UST (45 mg or 90 mg weight‐based dosing per label, n = 166). The primary end point was the proportion of patients reaching ≥ 90% Psoriasis Area and Severity Index improvement (PASI 90). Hommel‐adjusted key secondary end points at week 12 included PASI 75, PASI 100, static Physician's Global Assessment (sPGA) score of 0 or 1, sPGA score of 0, Dermatology Life Quality Index (DLQI) score of 0 or 1, ≥ 4‐point reduction on the itch numerical rating scale (NRS) and changes in itch NRS and skin pain visual analogue scale. At week 12, IXE (n = 99, 72·8%) was superior to UST (n = 70, 42·2%) in PASI 90 response (response difference 32·1%, 97·5% confidence interval 19·8−44·5%, P < 0·001). Response rates for PASI 75, PASI 100 and sPGA (0,1) were significantly higher for IXE than for UST (adjusted P < 0·05). At week 24, IXE‐treated patients had significantly higher response rates than UST‐treated patients for PASI, sPGA and DLQI (unadjusted P < 0·05). No deaths were reported, and the treatments did not differ with regard to overall incidences of adverse events (P = 0·299). The superior efficacy of IXE demonstrated at week 12 persisted up to week 24. The safety profiles were consistent with those previously reported for both treatments.Keywords
Funding Information
- Eli Lilly and Company
This publication has 28 references indexed in Scilit:
- Generation and characterization of ixekizumab, a humanized monoclonal antibody that neutralizes interleukin-17AJournal of Inflammation Research, 2016
- Immunology of PsoriasisAnnual Review of Immunology, 2014
- Dermal γδ T cells — A new player in the pathogenesis of psoriasisInternational Immunopharmacology, 2013
- Brodalumab, an Anti–Interleukin-17–Receptor Antibody for PsoriasisNew England Journal of Medicine, 2012
- Role of IL-17 in Psoriasis and Psoriatic ArthritisClinical Reviews in Allergy & Immunology, 2012
- Pivotal Role of Dermal IL-17-Producing γδ T Cells in Skin InflammationImmunity, 2011
- Effects of AIN457, a Fully Human Antibody to Interleukin-17A, on Psoriasis, Rheumatoid Arthritis, and UveitisScience Translational Medicine, 2010
- The role of IL-23 in the immunopathogenesis of psoriasisF1000 Biology Reports, 2010
- The IL-23/Th17 Axis in the Immunopathogenesis of PsoriasisJournal of Investigative Dermatology, 2009
- In Vitro and In Situ Expression of IL-23 by Keratinocytes in Healthy Skin and Psoriasis Lesions: Enhanced Expression in Psoriatic SkinPublished by The American Association of Immunologists ,2006