Comparison of ixekizumab with ustekinumab in moderate-to-severe psoriasis: 24-week results from IXORA-S, a Phase 3 study

Abstract

Background

The interleukin (IL)-23/IL-17 axis has been shown critical in the pathogenesis of psoriasis.

Objectives: To present the primary endpoint (Week 12) and safety/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).

Methods

Randomised patients received IXE (160-mg starting dose, then 80 mg every two weeks for 12 weeks, then 80 mg every four weeks, N=136) or UST (45 mg/90 mg weight-based dosing per label, N=166). The primary endpoint was the proportion of patients reaching ≥90% Psoriasis Area and Severity Index improvement (PASI 90). Hommel-adjusted key secondary endpoints at Week 12 included PASI 75, PASI 100, static physician global assessment (sPGA) (0,1), sPGA (0), Dermatology Life Quality Index (DLQI) score of (0,1), ≥4-point reduction on the itch Numeric Rating Scale (NRS), and changes in itch NRS and skin pain Visual Analog Scale (VAS).

Results

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<.001). Response rates for PASI 75, PASI 100, and sPGA (0,1) were significantly higher for IXE vs. UST (adjusted p<.05). At Week 24, IXE-treated patients had significantly higher response rates than UST-treated patients for PASI, sPGA, and DLQI (unadjusted p<.05). No deaths were reported, and treatments did not differ with regard to overall incidences of adverse events (p=.299).

Conclusions

The superior efficacy of IXE demonstrated at Week 12 persisted up to Week 24. Safety profiles were consistent with what has been previously reported for both treatments.

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