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比美克珠单抗治疗中重度斑块型银屑病患者:来自 BE ABLE 2 的 60 周结果,一项随机、双盲、安慰剂对照的 2b 期扩展研究。

Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study.

机构信息

Oregon Medical Research Center, Portland, Oregon.

Probity Medical Research and K. Papp Clinical Research, Waterloo, and University of Toronto, Toronto, Ontario.

出版信息

J Am Acad Dermatol. 2020 Nov;83(5):1367-1374. doi: 10.1016/j.jaad.2020.05.105. Epub 2020 May 29.


DOI:10.1016/j.jaad.2020.05.105
PMID:32473974
Abstract

BACKGROUND: Dual neutralization of both interleukin 17A and 17F with the monoclonal antibody bimekizumab may have greater efficacy in psoriasis than neutralization of interleukin 17A alone. OBJECTIVE: To provide longer-term efficacy and safety data for bimekizumab from a phase 2b extension study in patients with moderate to severe psoriasis (BE ABLE 2). METHODS: After the 12-week initial study (BE ABLE 1), patients who had a 90% improvement in Psoriasis Area and Severity Index (PASI 90) at week 12 received bimekizumab 64, 160, or 320 mg for an additional 48 weeks (60 weeks in total). The primary objective was safety. RESULTS: Across all dose groups (N = 217), initial PASI 90 responders generally maintained high levels of efficacy through week 60: PASI 90, 80% to 100%; 100% improvement in PASI, 69% to 83%; Investigator's Global Assessment score 0 or 1, 78% to 100% (all nonresponder imputation). Incidence of serious treatment-emergent adverse events was 15/217 (6.9%). No cases of inflammatory bowel disease, major adverse cardiovascular events, or suicidal ideation or behavior were reported. LIMITATIONS: Low numbers in the bimekizumab 64 mg group (n = 15). The majority of 60-week data reported here are primarily for the week 12 PASI 90 responders only. CONCLUSION: Bimekizumab response rates were maintained through week 60. A substantial proportion of patients achieved complete skin clearance. Bimekizumab was generally well tolerated.

摘要

背景:与单克隆抗体 bimekizumab 双重中和白细胞介素 17A 和 17F 可能比单独中和白细胞介素 17A 对银屑病更有效。

目的:提供来自中度至重度银屑病(BE ABLE 2)的 2b 期扩展研究中 bimekizumab 的更长时间疗效和安全性数据。

方法:在为期 12 周的初始研究(BE ABLE 1)之后,在第 12 周达到银屑病面积和严重程度指数(PASI 90)改善 90%的患者接受 bimekizumab 64、160 或 320 mg 治疗,再持续 48 周(总共 60 周)。主要目的是安全性。

结果:在所有剂量组(N=217)中,最初达到 PASI 90 的应答者通常在第 60 周时保持较高的疗效水平:PASI 90,80%至 100%;PASI 100%改善,69%至 83%;研究者全球评估评分 0 或 1,78%至 100%(所有非应答者推断)。严重治疗突发不良事件的发生率为 15/217(6.9%)。没有报告炎症性肠病、主要不良心血管事件或自杀意念或行为的病例。

局限性:bimekizumab 64 mg 组人数较少(n=15)。这里报告的 60 周数据主要是针对第 12 周 PASI 90 应答者。

结论:bimekizumab 的应答率在第 60 周保持不变。很大一部分患者达到了完全的皮肤清除。bimekizumab 通常具有良好的耐受性。

相似文献

[1]
Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study.

J Am Acad Dermatol. 2020-11

[2]
Dual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: Results from BE ABLE 1, a 12-week randomized, double-blinded, placebo-controlled phase 2b trial.

J Am Acad Dermatol. 2018-3-30

[3]
Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial.

Lancet. 2021-2-6

[4]
Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial.

Lancet. 2021-2-6

[5]
Bimekizumab versus Adalimumab in Plaque Psoriasis.

N Engl J Med. 2021-7-8

[6]
Bimekizumab versus Secukinumab in Plaque Psoriasis.

N Engl J Med. 2021-7-8

[7]
Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial.

Br J Dermatol. 2023-1-23

[8]
First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis.

Br J Clin Pharmacol. 2017-5

[9]
Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials.

Br J Dermatol. 2023-2-22

[10]
Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double-blind multicentre study.

Br J Dermatol. 2022-4

引用本文的文献

[1]
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.

Cochrane Database Syst Rev. 2025-8-6

[2]
Cardiovascular and Kidney Outcomes After Systemic Treatment for Plaque Psoriasis: A Systematic Review and Network Meta-analysis.

Dermatol Ther (Heidelb). 2025-7-5

[3]
Adverse events associated with bimekizumab for moderate-to-severe plaque psoriasis: A retrospective, multicenter, post-hoc analysis.

JAAD Int. 2025-3-18

[4]
The Role of Interleukin 23/17 Axis in Psoriasis Management: A Comprehensive Review of Clinical Trials.

Clin Cosmet Investig Dermatol. 2024-4-10

[5]
Risk of candidiasis associated with interleukin-17 inhibitors: Implications and management.

Mycology. 2023-10-20

[6]
The Efficacy and Safety of Bimekizumab for Plaque Psoriasis: An Expert Consensus Panel.

Dermatol Ther (Heidelb). 2024-2

[7]
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.

Cochrane Database Syst Rev. 2023-7-12

[8]
Bimekizumab in the Treatment of Plaque Psoriasis: Focus on Patient Selection and Perspectives.

Patient Prefer Adherence. 2023-6-30

[9]
Acrodermatitis continua of Hallopeau successfully treated with bimekizumab: A case report.

SAGE Open Med Case Rep. 2023-3-21

[10]
Adverse events associated with anti-IL-17 agents for psoriasis and psoriatic arthritis: a systematic scoping review.

Front Immunol. 2023

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