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

• Published in: British journal of dermatology (1951) Vol. 178; no. 3; pp. 674 - 681
• Main Authors: Papp, K.A., Leonardi, C.L., Blauvelt, A., Reich, K., Korman, N.J., Ohtsuki, M., Paul, C., Ball, S., Cameron, G.S., Erickson, J., Zhang, L., Mallbris, L., Griffiths, C.E.M.
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01-03-2018
• Subjects: Etanercept; Fingernail; Monoclonal antibodies; Patients; Psoriasis
• ISSN: 0007-0963; 1365-2133
• DOI: 10.1111/bjd.16050

Summary
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 III psoriasis studies.
Methods
Data were integrated from the 12‐week induction period of three studies in which patients received ixekizumab 80 mg every 2 weeks (IXE Q2W; n = 1169) or every 4 weeks (IXE Q4W; n = 1165) after an initial 160‐mg dose for both; etanercept (50 mg biweekly; n = 740; two studies) or placebo (n = 792). The coprimary end points were the percentages of patients with response of static Physician's Global Assessment (sPGA; score 0 or 1) and ≥ 75% improvement in baseline Psoriasis Area and 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 frequencies of patients achieving PASI 75, 90 and 100 were nearly 90%, 70% and 40%, respectively. Ixekizumab‐treated patients showed significantly greater improvement vs. placebo and etanercept in percentage 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 to placebo and etanercept, with IXE Q2W providing better outcomes than IXE Q4W during the first 12 weeks of treatment.
What's already known about this topic?
Study results have been reported from each of the pivotal phase III trials that compared two dose schedules of ixekizumab (a high‐affinity anti‐interleukin‐17A antibody) with placebo and/or etanercept (a tumour necrosis factor blocker) in the treatment of plaque psoriasis.
What does this study add?
We provide a comprehensive overview of ixekizumab therapy for moderate‐to‐severe plaque psoriasis by presenting integrated 12‐week efficacy outcomes for two ixekizumab dosing regimens from the pivotal phase III studies.
Linked Comment: Fleming. Br J Dermatol 2018; 178:585–586
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