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

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Papp KA1,2, Bachelez H3, Blauvelt A4, Winthrop KL5, Romiti R6, Ohtsuki M7, Acharya N8, Braun DK8, Mallbris L8, Zhao F8, Xu W8, Walls CD8, Strober B2,9. Br J Dermatol. 2017 Dec;177(6):1537-1551. doi: 10.1111/bjd.15723. Epub 2017 Nov 16.

Abstract

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1 K. Papp Clinical Research, Waterloo, ON, Canada.

2 Probity Medical Research, Waterloo, ON, Canada.

3 Service de Dermatologie, AP-HP Hôpital Saint Louis, Sorbonne Paris Cité Université Paris Diderot, Paris, France.

4 Oregon Medical Research Center, Portland, OR, U.S.A.

5 Oregon Health and Science University, Portland, OR, U.S.A.

6 Departament of Dermatology, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.

7 Department of Dermatology, Jichi Medical University, Shimotsuke, Japan.

8 Eli Lilly and Company, Indianapolis, IN, U.S.A.

9 Department of Dermatology, University of Connecticut Health Center, Farmington, CT, U.S.A.

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.