AB0938 SAFETY PROFILE OF BIMEKIZUMAB AT WEEK 16 IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS AND PSORIATIC ARTHRITIS: RESULTS FROM FOUR PLACEBO-CONTROLLED PHASE 3 STUDIES

Abstract

Background: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)‐17F in addition to IL‐17A. Objectives: To report Week (Wk) 0‐16 safety of BKZ and placebo (PBO) in 2 axial spondyloarthritis (axSpA) and 2 psoriatic arthritis (PsA) phase 3 studies. Methods: Patients (pts) in 2 safety pools received ≥1 dose of subcutaneous BKZ 160 mg or PBO every 4 wks during Wks 0‐16 (double‐blind phase) of BE MOBILE 1 + BE MOBILE 2 in axSpA (NCT03928704; 03928743); BE OPTIMAL + BE COMPLETE in PsA (NCT03895203; 03896581) (Figure 1) [1‐4]. Results: Wk 16 completion rates: 95.8% (PBO), 97.1% (BKZ) in axSpA; 95.9% (PBO), 97.1% (BKZ) in PsA. Most frequently reported treatment‐emergent adverse events in ≥3% pts on BKZ were nasopharyngitis, upper respiratory tract infection, oral candidiasis and headache (Table 1). See Table for adverse events of special interest. Serious infections occurred in 5 pts (axSpA: 1 [0.4%] PBO, 1 [0.3%] BKZ; PsA: 0 PBO, 3 [0.4%] BKZ). Fungal infections were all local and reported as mild/ moderate by investigators; more Candida infections were seen on BKZ (axSpA: 15 pts [4.3%]; PsA: 18 [2.6%]) than PBO (axSpA: 0; PsA: 2 [0.5%]) and led to discontinuation by 3 pts on BKZ (1 axSpA, 2 PsA). In axSpA pts, uveitis occurred in 11 (4.6%) on PBO and 2 (0.6%) on BKZ; inflammatory bowel disease occurred in 1 (0.4%) pt on PBO, 2 (0.6%) on BKZ. No uveitis/IBD cases in PsA by Wk 16 (PBO or BKZ). No deaths, active tuberculosis, suicidal ideation/behaviour, or major adverse cardiac events were reported in any study to Wk 16. Conclusion: The overall safety profile of BKZ was in line with previous phase 2 trials in axSpA and PsA, with a low rate of discontinuation. As expected, due to inhibition of IL‐17, there was a higher rate of oral candidiasis compared to PBO. (Figure Presented).