AB0802 SAFETY PROFILES OF IXEKIZUMAB VERSUS ADALIMUMAB: 52-WEEK RESULTS FROM A HEAD-TO-HEAD COMPARISON IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Abstract

Background:Ixekizumab (IXE) was shown to be superior to adalimumab (ADA) in achievement of simultaneous improvement of joint and skin disease (ACR50 and PASI100) in patients with active psoriatic arthritis (PsA) and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).1Objectives:To compare the safety and tolerability profile of IXE vs ADA in patients with PsA up to 52 weeks of treatment.Methods:SPIRIT-H2H (NCT03151551) was an open-label, head-to-head, blinded assessor clinical trial which included patients with active PsA (≥3 tender joint count + ≥3 swollen joint count) and plaque psoriasis (BSA ≥3%) who were inadequate responders to csDMARD therapy but naïve to biologic DMARDs. Patients were randomized (1:1) to approved dosing of IXE or ADA. Safety events were assessed at each patient visit up to Week 52. Frequencies of adverse events (AEs) were based on the number of patients in the safety population (patients who received ≥1 dose of study drug). Cases of inflammatory bowel disease (IBD) and cerebro-cardiovascular events were adjudicated by external committees. Kaplan-Meier analysis of time to onset of serious adverse events (SAEs) was performed.Results:Of the 283 patients randomized to each treatment, 87% (246/283) of patients who received IXE and 84% (237/283) of patients who received ADA completed 52 weeks of treatment. The frequency of treatment-emergent AEs (TEAEs) was similar between the groups (74% IXE vs 69% ADA), however fewer severe TEAEs were reported in the IXE group (3.2% IXE vs 7.1% ADA) (Table). SAEs were significantly more frequent in the ADA group compared to the IXE group (12% vs 4.2%; p<0.001), and the time to develop a patient’s first SAE was significantly shorter for ADA versus IXE (p<0.001; Figure). Discontinuations due to AEs were numerically more frequent in the ADA group versus the IXE group (7.4% vs 4.2%; p=0.15). IXE-treated patients reported more injection-site reactions (ISR) than ADA-treated patients (11% vs. 3.5%; p=0.002). Study withdrawals due to ISR were comparable, and only one injection-site reaction was severe on ADA (Table). There were two IBD cases reported for IXE; one case was confirmed as IBD.Conclusion:Safety results were consistent with previous trials with IXE and ADA. Compared with IXE, patients with PsA treated with ADA had significantly more serious AEs.