Safety and Efficacy of Bimekizumab Self-Administration in Psoriasis Patients
Patient adherence to regular administration of biologic therapy is crucial for its effectiveness. The studies presented below evaluated self-administration of the humanized monoclonal antibody against IL-17A and IL-17F, bimekizumab, in patients with plaque psoriasis using a prefilled syringe or autoinjector.
Methodology, Course, and Objectives of the Studies
The multicenter, randomized, open-label phase III studies DV0002 and DV0006 (sub-study BE BRIGHT) included a total of 134 and 88 adult patients, respectively, with moderate to severe plaque psoriasis. They administered bimekizumab at a dose of 320 mg (2× 160 mg) subcutaneously into the abdomen or outer thigh every 4 or 8 weeks depending on the PASI (Psoriasis Area Severity Index) score. They were randomized in a 1:1 ratio into 2 groups for administration using a prefilled safety syringe or autoinjector.
The primary endpoint was the patient's ability to safely and effectively administer bimekizumab after 8 weeks, and the secondary endpoint was the ability for safe and effective administration immediately post-education. Patient experience was assessed using a visual analog scale (VAS) for pain on a scale from 0 to 100 mm (0 = no pain, 100 = unbearable pain) and the SIAQ (Self-Injection Assessment Questionnaire) scale from 0 to 10, where 10 = most positive experience.
Results
A total of 125 and 86 patients completed the DV0002 and DV0006 studies, respectively. Eight weeks after education, all patients in both studies administered bimekizumab safely and effectively. Immediately after education, administration was safe and effective for all patients in study DV0006 and for all patients using the prefilled syringe and 97.1% (n = 66) of those using the autoinjector in study DV0002. The average VAS score was low (7.0–20.0) and SIAQ was high (5.8–10.0 and 7.1–10.0), for both types of administration across all time points. Adverse events (mild injection site reactions) were observed in only 7 patients.
Conclusion
Using a prefilled syringe and autoinjector represents a safe and effective method for the self-administration of bimekizumab in patients with moderate to severe plaque psoriasis. Patients thus have an option regarding the control of the administration of the active substance, which may also increase their compliance with the treatment. However, the study is limited by the small number of subjects and the short tracking period.
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Source: 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.
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