Infections from 7 Clinical Trials of Ixekizumab, an Anti-Interleukin-17A Monoclonal Antibody, in Patients with Moderate-to-Severe Psoriasis

Abstract

Background

Infections are associated with biologic therapies in psoriasis.

Objectives

To summarise the incidence of infections in moderate-to-severe psoriasis patients treated with ixekizumab, an anti-interleukin (IL)-17A monoclonal antibody.

Methods

Infections are summarised from an integrated database of 7 controlled and uncontrolled ixekizumab psoriasis trials. Data are presented from placebo-controlled induction (Weeks 0-12; UNCOVER-1, -2, and -3) and maintenance periods (Weeks 12-60; UNCOVER-1 and -2) as well as all ixekizumab-exposed patients pooled from all 7 trials. Comparisons to etanercept were made during the induction period of two trials (UNCOVER-2 and -3). Incidence and exposure-adjusted incidence rates (IRs) per 100 patient-years (PY) are reported.

Results

Overall, 4209 patients were treated with ixekizumab (6480PY). During induction (Weeks 0-12), overall infection rates were higher in ixekizumab-treated patients (27%) versus placebo (23%, p<0.05); however, specific infection rates were overall comparable across treatment groups. IRs of infections did not increase with longer-term exposure. For all ixekizumab-treated patients (all 7 trials), the incidence of serious infections was low (2%; IR 1.3). Candida infections, including 8 oesophageal candidiasis cases, were adequately managed with anti-fungal therapy, were non-invasive, and did not lead to discontinuation.

Conclusions

Infections overall occurred in a higher percentage of ixekizumab-treated patients versus placebo during the first 12 weeks of treatment; however, specific infection rates were overall comparable across treatment groups. Incidences of serious infections were low and similar across treatment groups.

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