Safety of Ixekizumab in Patients With Psoriatic Arthritis: Results From a Pooled Analysis of Three Clinical Trials.

Abstract

ObjectiveTo evaluate ixekizumab safety in adults with psoriatic arthritis (PsA).MethodsSafety data from 2 integrated data sets are presented: 1) 24‐week, double‐blind, placebo‐controlled period of SPIRIT‐P1 and SPIRIT‐P2; and 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 per 100 patient‐years at 12‐week intervals to week 96.ResultsThe placebo‐controlled period had 678 patients (safety population): 224 placebo, 229 ixekizumab every 4 weeks, and 225 ixekizumab every 2 weeks. Overall, 1,118 patients received ixekizumab (total exposure 1,373.4 patient‐years). In the placebo‐controlled period, the frequencies of ixekizumab‐treated patients experiencing ≥1 treatment‐emergent AE (TEAE) and those experiencing serious AEs were 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, the incidence rates of ISRs decreased with increasing ixekizumab exposure. The frequencies of AEs of special interest were 32.8% (ixekizumab) and 27.7% (placebo); for serious infections, the frequencies were 1.3% and 0%, respectively; Candida infections, 2.6% and 0.4%; confirmed major adverse cardiac events, 0% and 0%; malignancy, 0.4% and 0%; hypersensitivities, 5.3% and 1.8%; and depression‐related, 1.8% and 1.3%. The frequency of Crohn's disease and ulcerative colitis (investigator‐reported) was 0% in both groups, and the frequencies of sponsor‐determined inflammatory bowel disease were 0.2% in the ixekizumab group and 0% in the placebo group. Overall, no active tuberculosis, invasive Candida infections, anaphylaxis, or suicide/self‐injury behaviors were reported.ConclusionThe PsA ixekizumab safety integrated data set reached 1,373.4 patient‐years total exposure. Ixekizumab‐treated patients had higher rates of overall TEAEs, serious infections, mucocutaneous Candida, hypersensitivities (non‐anaphylactic), and ISRs than placebo‐treated patients. No unexpected safety outcomes were reported.