5 years ago

Ixekizumab treatment for psoriasis: Integrated efficacy analysis of three double-blinded, controlled studies (UNCOVER-1, UNCOVER-2, UNCOVER-3)

K. Reich, S. Ball, C. Paul, G.S. Cameron, C.E.M. Griffiths, L. Zhang, A. Blauvelt, L. Mallbris, N.J. Korman, C.L. Leonardi, K.A. Papp, J. Erickson, M. Ohtsuki
Background Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A, is approved for the treatment of moderate-to-severe psoriasis. Objectives This analysis represents an overview of the efficacy outcomes from three Phase 3 psoriasis studies. Methods Data were integrated from the 12-week induction period of three studies in which patients received ixekizumab 80 mg every 2 (IXE Q2W; N=1169) or 4 weeks (IXE Q4W; N=1165) after an initial 160-mg dose for both, etanercept (ETN) (50 mg biweekly; N=740; two studies), or placebo (PBO) (N=792). The co-primary endpoints were the percentages of patients with response of sPGA (0,1) and a 75% improvement in baseline psoriasis area severity index (PASI 75) at Week 12. Response rates were compared between treatments using the Cochran-Mantel-Haenszel test stratified by study. Treatment comparisons with placebo included data from three studies, whereas etanercept comparisons were based on two studies. Results Ixekizumab treatment was superior to placebo (p<0.001) and etanercept (p<0.001) on sPGA (0,1) and PASI 75, with significant differences in PASI improvement at Week 1. With IXE Q2W, at Week 12, the frequency of patients achieving PASI 75/90/100 was nearly 90%/70%/40%, respectively. Ixekizumab-treated patients showed significantly greater improvement versus placebo and etanercept in percent body surface area involvement and fingernail psoriasis. IXE Q2W was superior to IXE Q4W on all treatment outcomes. Conclusions Ixekizumab therapy at both dosing regimens demonstrated rapid onset and superior efficacy compared with placebo and etanercept, with IXE Q2W providing better outcomes than IXE Q4W during the first 12 weeks of treatment. This article is protected by copyright. All rights reserved.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/bjd.16050

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