Infection rates (IRs) in patients with moderate to severe psoriasis treated with ixekizumab are similar to rates seen across other treatment groups, according to the results of a recent analysis of 7 phase 3 clinical trials published in the British Journal of Dermatology.
All infections from an integrated database of 7 trials were summarized. Data are presented from placebo-controlled induction (weeks 0 to 12; UNCOVER-1, UNCOVER-2, and UNCOVER-3) and maintenance periods (weeks 12 to 60; UNCOVER-1, UNCOVER-2, and UNCOVER-3), as well as from all ixekizumab-treated patients from all 7 trials. Incidence and exposure-adjusted incidence rates (IRs) per 100 patient-years (PYs) were reported in the analysis.
A total of 4209 patients age ≥18 received at least 1 dose of ixekizumab (6480 person-years of total exposure; median, 507 days; maximum, 1794 days). At weeks 1 to 12 (induction period), overall infection rates were higher in ixekizumab-treated patients compared with placebo-treated patients (27% vs 23%, respectively; P <.05). Specific infection rates were similar across treatment groups. The infections evaluated included tuberculosis, Candida infections, staphylococcal infections, herpes zoster, viral hepatitis, and infections preceded or accompanied by neutropenia (most commonly nasopharyngitis, upper respiratory tract infection, rhinitis, and urinary tract infection).
IRs did not rise with longer-term treatment exposure. In all ixekizumab-treated patients in all 7 trials, the incidence of serious infections was low (2%; IR, 1 to 3). Candida infections were adequately managed and did not lead to treatment discontinuation in any patients.
The investigators concluded that in ixekizumab-treated patients, the incidence of serious infections is low and is comparable across treatment groups. In patients who received ixekizumab therapy for ≤4 years, treatment-emergent infections were consistent with those typically expected with the use of IL-17A antagonists.
Papp KA, Bachelez H, Blauvelt A, et al. Infections from seven clinical trials of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe psoriasis [published online June 10, 2017]. Br J Dermatol. doi:10.1111/bjd.15723