Michael Sebastian, Jerry Bagel, Bengt Hoepken, Bertram Knapp, Ceyhun Bicer, Merran MacPherson, Richard G Langley
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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.</p><p><strong>Results: </strong>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. 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引用次数: 0
摘要
简介与安慰剂、阿达木单抗、乌斯特库单抗和secukinumab相比，比美单抗在治疗银屑病方面具有良好的安全性和快速、卓越的疗效。之前的一项研究表明，使用安全注射器（SSy）或自动注射器（AI）装置，通过两次1毫升（2 × 160毫克）剂量的皮下自我注射，可安全有效地注射320毫克的bimekizumab。通过单次 2 毫升自我注射给药 320 毫克比美珠单抗可改善患者的治疗体验：我们介绍了四项研究的结果。两项自我注射体验研究（DV0002 [n = 38] 和 DV0006 [n = 89]，3 期研究 BE BRIGHT [NCT03598790] 的子研究）评估了中度至重度斑块状银屑病患者使用 2 mL SSy 或 AI 在第 8 周和基线时自我给药比美珠单抗的安全性和有效性，以及患者的自我注射体验和疼痛。此外，我们还报告了两项生物等效性研究（UP0068 [n = 71] 和 UP0119 [n = 121]），这两项研究描述了健康参与者使用 SSy 或 AI 装置进行两次 1 mL 注射和一次 2 mL 注射的药代动力学特征：所有患者在基线和第8周均能使用不同的2 mL装置进行安全有效的自我注射，只有一名患者因注射部位轻微疼痛而未完成注射。总体而言，患者对比美珠单抗的耐受性普遍良好，所报告的所有不良反应都很轻微，没有导致停药。患者反映自我注射体验良好，疼痛评分较低（均≤12.0/100）。使用SSy和AI，一次2毫升注射和两次1毫升注射的bimekizumab生物等效性均已得到证实：2 mL SSy和AI装置为中度至重度斑块状银屑病患者提供了两种不同的安全有效的bimekizumab给药选择，使患者能够根据个人喜好选择装置。本文有图表摘要：ClinicalTrials.gov 标识符：NCT03766685。
Single-Injection Options for Administering a 320 mg Dose of Bimekizumab: 2 mL Safety Syringe and Auto-injector.
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.
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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