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Introduction <p>Bimekizumab has a favourable safety profile and has demonstrated rapid and superior efficacy, compared with placebo, adalimumab, ustekinumab, and secukinumab, in treating psoriasis. A previous study demonstrated the safe and effective subcutaneous self-injection of 320&#xa0;mg bimekizumab via two 1&#xa0;mL (2 × 160&#xa0;mg) doses using safety syringe (SSy) or auto-injector (AI) devices. Delivery of 320&#xa0;mg bimekizumab via a single 2&#xa0;mL self-injection could lead to an improved treatment experience for patients.</p> Methods <p>We describe the results from four studies. Two self-injection experience studies (DV0002 [<i>n</i> = 38] and DV0006 [<i>n</i> = 89], sub-studies of the phase&#xa0;3 study BE&#xa0;BRIGHT [NCT03598790]) assessed the safe and effective self-administration of bimekizumab at week&#xa0;8 and baseline, as well as patient self-injection experience and pain, in patients with moderate to severe plaque psoriasis using the 2&#xa0;mL SSy or AI. Additionally, we report on two bioequivalence studies (UP0068 [<i>n</i> = 71] and UP0119 [<i>n</i> = 121]) that describe pharmacokinetic profiles for two 1&#xa0;mL injections and a single 2&#xa0;mL injection, delivered by SSy or AI devices in healthy participants.</p> Results <p>All patients were able to administer safe and effective self-injections at baseline and week&#xa0;8 using the different 2 mL devices, except one patient that administered an incomplete dose as a result of injection site pain that was mild. Overall, bimekizumab was generally well tolerated and all adverse device effects reported were mild and did not lead to discontinuation. Patients reported a positive self-injection experience with low pain scores (all ≤ 12.0/100). Bioequivalence was demonstrated for bimekizumab between a single 2 mL injection and two 1 mL injections, using both the SSy and AI.</p> Conclusion <p>The 2 mL SSy and AI devices offer patients with moderate to severe plaque psoriasis two different safe and effective options for the delivery of bimekizumab, empowering individuals to select a device on the basis of personal preference.</p> <p>Graphical abstract available for this article.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT03766685.</p> Graphical Abstract <p></p>

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Single-Injection Options for Administering a 320 mg Dose of Bimekizumab: 2 mL Safety Syringe and Auto-injector

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月29日

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  • Michael Sebastian,
  • Jerry Bagel,
  • Bengt Hoepken,
  • Bertram Knapp,
  • Ceyhun Bicer,
  • Merran MacPherson,
  • Richard G. Langley

摘要

Introduction

Bimekizumab has a favourable safety profile and has demonstrated rapid and superior efficacy, compared with placebo, adalimumab, ustekinumab, and secukinumab, in treating psoriasis. A previous study demonstrated the safe and effective subcutaneous self-injection of 320 mg bimekizumab via two 1 mL (2 × 160 mg) doses using safety syringe (SSy) or auto-injector (AI) devices. Delivery of 320 mg bimekizumab via a single 2 mL self-injection could lead to an improved treatment experience for patients.

Methods

We describe the results from four studies. Two self-injection experience studies (DV0002 [n = 38] and DV0006 [n = 89], sub-studies of the phase 3 study BE BRIGHT [NCT03598790]) assessed the safe and effective self-administration of bimekizumab at week 8 and baseline, as well as patient self-injection experience and pain, in patients with moderate to severe plaque psoriasis using the 2 mL SSy or AI. Additionally, we report on two bioequivalence studies (UP0068 [n = 71] and UP0119 [n = 121]) that describe pharmacokinetic profiles for two 1 mL injections and a single 2 mL injection, delivered by SSy or AI devices in healthy participants.

Results

All patients were able to administer safe and effective self-injections at baseline and week 8 using the different 2 mL devices, except one patient that administered an incomplete dose as a result of injection site pain that was mild. Overall, bimekizumab was generally well tolerated and all adverse device effects reported were mild and did not lead to discontinuation. Patients reported a positive self-injection experience with low pain scores (all ≤ 12.0/100). Bioequivalence was demonstrated for bimekizumab between a single 2 mL injection and two 1 mL injections, using both the SSy and AI.

Conclusion

The 2 mL SSy and AI devices offer patients with moderate to severe plaque psoriasis two different safe and effective options for the delivery of bimekizumab, empowering individuals to select a device on the basis of personal preference.

Graphical abstract available for this article.

Trial Registration

ClinicalTrials.gov identifier, NCT03766685.

Graphical Abstract