Safety of Ixekizumab in Patients with Psoriatic Arthritis: Results from a Pooled Analysis of Three Clinical Trials.
OBJECTIVE: To evaluate ixekizumab safety in adults with psoriatic arthritis (PsA).
METHODS: Safety data from 2 integrated datasets are presented: 1) 24-week, double-blind, placebo-controlled period of SPIRIT-P1 and SPIRIT-P2; 2) all ixekizumab-treated patients of SPIRIT-P1 and SPIRIT-P2 plus SPIRIT-P3 open-label period. We report adverse event (AE) frequency and exposure-adjusted incidence rates (IRs) per 100 patient-years (PY) at 12-week intervals to Week 96.
RESULTS: The placebo-controlled period had 678 patients (safety population): 224 placebo, 229 ixekizumab every 4 weeks, and 225 ixekizumab every 2 weeks. Overall, 1118 patients received ixekizumab (total exposure=1373.4 PY). In the placebo-controlled period, the frequency of ixekizumab-treated patients experiencing ≥1 treatment-emergent AE (TEAE) and serious AE was 68.1% (56.7% placebo) and 4.4% (2.7% placebo), respectively. Injection site reactions (ISRs) were very common (21.4% ixekizumab [4.5% placebo]), with ISR discontinuation rates of 1.1% (ixekizumab) and 0.4% (placebo). Through Week 96, IRs of ISRs decreased with increasing ixekizumab exposure. Frequencies of AEs of special interest were (ixekizumab/placebo): infections (32.8%/27.7%), serious infections (1.3%/0%), Candida infections (2.6%/0.4%), confirmed major adverse cardiac events (0%/0%), malignancy (0.4%/0%), hypersensitivities (5.3%/1.8%), and depression-related (1.8%/1.3%), with 0% Crohn's disease or ulcerative colitis (investigator-reported; sponsor-determined inflammatory bowel disease in 0.2% [0% placebo]). Overall, no active tuberculosis, invasive Candida infections, anaphylaxis, or suicide/self-injury behaviors were reported.
CONCLUSION: The PsA ixekizumab safety integrated dataset reached 1373.4 PY total exposure. Ixekizumab-treated patients had higher rates of overall TEAEs, serious infections, mucocutaneous Candida, hypersensitivities (non-anaphylactic), and ISRs than placebo. No unexpected safety outcomes were reported. This article is protected by copyright. All rights reserved.