Self-administration of Subcutaneous Bimekizumab Proves Safe, Effective in PsA

Patients with psoriatic arthritis (PsA) successfully self-administered subcutaneous bimekizumab without any safety concerns at both baseline and week 4, according to a study published in Patient Preference and Adherence.¹ In general, patients expressed satisfaction with their experience.

Alan Kivitz, MD

Credit: Altoona Center for Clinical Research

Bimekizumab has been proven to be safe and effective in previous phase 2 and 3 trials of patients with PsA, axial spondyloarthritis (axSpA), and psoriasis. The drug, an interleukin (IL)-17F and IL-17A inhibitor, must be administered subcutaneously.² Therefore, patients should have self-injection options that they are comfortable with.

“Self-injection offers patients control and independence over the injection, the setting, and the injection schedule,” wrote lead investigator, Alan Kivitz, MD, clinician at the Altoona Center for Clinical Research, and colleagues. “Previous studies have also reported that availability of, and education on, a self-injection device that meets patients’ preferences is associated with increased adherence to treatment, a greater proportion of patients self-injecting medication and a smaller proportion of patients attending primary care for administration, translating into a reduction in healthcare costs. Despite these benefits, some patients face barriers to self-injection such as needle anxiety and lack of confidence.”

The DV0004 devices study was a sub-study within the broader BE VITAL initiative, which is an open-label extension of BE OPTIMAL and BE COMPLETE, which enrolled patients with active PsA. After training, patients were instructed to self-inject subcutaneous bimekizumab 160 mg at baseline and week 4. Patients were randomized 1:1 to receive either the 1 mL safety syringe (SSy) or the 1 mL auto-injector (AI).

The primary and secondary objectives focused on the proportion of patients who were able to inject the subcutaneous drug safely and effectively at week 4 and baseline, respectively. The patient experience was assessed using the Pain Visual Analog Scale (VAS) and the Self-Injection Assessment Questionnaire (SIAQ).

A total of 214 patients were enrolled in the study, with all patients successfully self-injecting bimekizumab at baseline (SSy: n = 106; AI: n = 106) and week 4 (SSy: n = 105; AI: n = 104). The mean VAS scores at baseline (SSy: 9.5; AI: 14.9) and week 4 (SSy: 11.0; AI: 11.4) were generally low among both groups. The SIAQ scores were high (≥6.7) pre- and post-injection in both the SSy and AI cohorts.

Self-injection was generally well tolerated among patients. Four non-device-related injection site reactions were observed in the sub-study, all categorized as mild, none led to discontinuation, and resolved without treatment. No treatment-emergent adverse device effects (TEADEs), serious TEADEs, or discontinuations due to TEADEs were reported. All devices maintained functionality and structure post-use.

Investigators noted the analysis of the questionnaires used data from a subgroup of patients, although the primary and secondary objectives were evaluated using the entire cohort. While they view this as a limitation, the results from the subgroup analyses were comparable with the total patient population. Additionally, results may not be generalizable or reflective of a real-world situation as it was performed in a controlled clinical trial context. Future research conducted in a real-world setting could help to determine whether patients can safely and effectively self-inject for longer periods of time.

“Overall, patients reported a positive self-injection experience and generally low injection site pain when using either device,” investigators concluded. “The SSy and AI devices provide patients with PsA 2 safe and effective options for the self-injection of bimekizumab that will suit their personal preferences.”

References

1. ^{Kivitz A, Ellis AM, Shende V, Lambert J, Tatla D. Safe and Effective Subcutaneous Self-Injection of Bimekizumab with Safety Syringe and Auto-Injector Devices: Results from a Multicenter, Randomized, Open-Label Study in Patients with Psoriatic Arthritis. Patient Prefer Adherence. 2023;17:2451-2461. Published 2023 Oct 3. doi:10.2147/PPA.S427809}
2. ^{Bagel J, Tatla D, Hellot S, et al. Bimekizumab self-injection devices: two multicenter, randomized, open-label studies on self-administration by patients with psoriasis. J Drugs Dermatol. 2022;21(2):162–171. doi:10.36849/JDD.6274}