Infections from seven clinical trials of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe psoriasis

K. A. Papp, H. Bachelez, A. Blauvelt, K. L. Winthrop, R. Romiti, M. Ohtsuki, N. Acharya, D. K. Braun, L. Mallbris, F. Zhao, W. Xu, C. D. Walls, B. Strober

Research output: Contribution to journalArticlepeer-review

23 Scopus citations

Abstract

Background: Infections are associated with biological therapies in psoriasis. Objectives: To summarize the incidence of infections in patients with moderate-to-severe psoriasis treated with ixekizumab, an anti-interleukin-17A monoclonal antibody. Methods: Infections are summarized from an integrated database of seven controlled and uncontrolled ixekizumab psoriasis trials. Data are presented from placebo-controlled induction (weeks 0–12; UNCOVER-1, UNCOVER-2 and UNCOVER-3) and maintenance periods (weeks 12–60; UNCOVER-1 and UNCOVER-2), and all patients exposed to ixekizumab pooled from all seven trials. Comparisons with etanercept were made during the induction period of two trials (UNCOVER-2 and UNCOVER-3). Incidence and exposure-adjusted incidence rates (IRs) per 100 patient-years (PYs) are reported. Results: Overall, 4209 patients were treated with ixekizumab (6480 PY). During induction (weeks 0–12), overall infection rates were higher in patients treated with ixekizumab (27%) vs. placebo (23%, P < 0·05); however, specific infection rates were comparable overall across treatment groups. IRs of infections did not increase with longer-term exposure. For all patients treated with ixekizumab (all seven trials), the incidence of serious infections was low (2%, IR 1·3). Candida infections, including eight cases of oesophageal candidiasis, were adequately managed with antifungal therapy, were noninvasive and did not lead to discontinuation. Conclusions: Overall, infections occurred in a higher percentage of patients treated with ixekizumab vs. placebo during the first 12 weeks of treatment; however, specific infection rates were comparable overall across treatment groups. Incidences of serious infections were low and similar across treatment groups.

Original languageEnglish (US)
Pages (from-to)1537-1551
Number of pages15
JournalBritish Journal of Dermatology
Volume177
Issue number6
DOIs
StatePublished - 2017

ASJC Scopus subject areas

  • Dermatology

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