Bimekizumab Self-Injection Devices:Two Multicenter, Randomized, Open-Label Studies on Self-Administration by Patients with Psoriasis

Abstract

Background: Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. Objectives: To assess patients’ ability to self-inject bimekizumab subcutaneously using a 1 mL safety syringe or auto-injector. Methods: DV0002 and DV0006 were sub-studies of BE BRIGHT, a multicenter, phase 3 open-label extension study. Patients with moderate to severe plaque psoriasis received bimekizumab 320 mg (2x160 mg injections) every 4 or 8 weeks and were randomized 1:1 to the safety syringe or the auto-injector. The ability of patients to safely and effectively self-inject bimekizumab was assessed at 8 weeks (primary endpoint) and immediately after self-injection training at Baseline (secondary endpoint). Patient experience was evaluated using the pain visual analog scale (VAS; 0–100 mm; 100 being worst pain), and the Self-Injection Assessment Questionnaire (SIAQ; 0–10; 10 being most positive experience). Results: All evaluable patients in DV0002 (n=125) and DV0006 (n=86) safely and effectively self-injected bimekizumab at Week 8. All evaluable patients in DV0002 who used the safety syringe (n=64) and 97.1% (n=66/68) who used the auto-injector, as well as all evaluable DV0006 patients (n=88) also self-injected bimekizumab safely and effectively at Baseline. Median VAS scores were low (range: 7.0–20.0), and median pre-injection and post-injection Do SIAQ Not scores Copy were high (range: 5.8–10.0 and 7.1–10.0, respectively) across both devices, sub-studies, and timepoints. Conclusions: Both devices provide a safe and effective Penalties option for patients Apply to self-administer bimekizumab. Furthermore, patients reported a positive self-injection experience.