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比美吉珠单抗治疗化脓性汗腺炎。

Bimekizumab for the treatment of hidradenitis suppurativa.

机构信息

University of North Carolina Chapel Hill School of Medicine, 321 S Columbia St, Chapel Hill, NC 27599, USA.

University of North Carolina Chapel Hill Department of Dermatology, 410 Market Street Suite 400A, Chapel Hill, NC 27516, USA.

出版信息

Immunotherapy. 2024;16(16-17):1005-1013. doi: 10.1080/1750743X.2024.2401308. Epub 2024 Sep 19.

DOI:10.1080/1750743X.2024.2401308
PMID:39297706
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11492705/
Abstract

Hidradenitis suppurativa (HS) is a painful, inflammatory dermatosis involving recurrent abscesses, nodules and tunnels in intertriginous regions. Biologics and other immunomodulators have significantly expanded the treatment options available for HS. Bimekizumab is a monoclonal antibody targeting both interleukin-17A and interleukin-17F, key mediators of inflammation, that is already approved for psoriasis, psoriatic arthritis and axial spondylarthritis. It is currently pending FDA review for HS treatment but has already received marketing authorization for this indication in Europe. This review aims to explore drug-specific characteristics of bimekizumab including its mechanism of action, pharmacokinetics and pharmacodynamics and the current state of the literature regarding its use in HS such as safety, efficacy and dosing, while highlighting its implications in clinical practice. Recent Phase II and III trial data demonstrating positive efficacy and safety profiles in the treatment of HS will also be detailed.

摘要

化脓性汗腺炎(HS)是一种疼痛性炎症性皮肤病,涉及易摩擦部位反复发作的脓肿、结节和瘘道。生物制剂和其他免疫调节剂极大地扩展了 HS 的治疗选择。Bimekizumab 是一种针对白细胞介素-17A 和白细胞介素-17F 的单克隆抗体,这两种细胞因子是炎症的关键介质,已被批准用于治疗银屑病、银屑病关节炎和中轴型脊柱关节炎。它目前正在接受 FDA 对 HS 治疗的审查,但已在欧洲获得该适应症的上市许可。本综述旨在探讨 bimekizumab 的药物特异性特征,包括其作用机制、药代动力学和药效学,以及目前关于其在 HS 中的应用的文献,如安全性、疗效和剂量,同时强调其在临床实践中的意义。还将详细介绍最近的 II 期和 III 期试验数据,这些数据表明 bimekizumab 在治疗 HS 方面具有积极的疗效和安全性。

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Bimekizumab for the treatment of hidradenitis suppurativa.比美吉珠单抗治疗化脓性汗腺炎。
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2
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Bimekizumab efficacy and safety through 3 years in patients with moderate to severe plaque psoriasis: Long-term results from the BE RADIANT phase 3b trial open-label extension period.在中度至重度斑块状银屑病患者中,比美吉珠单抗三年的疗效和安全性:BE RADIANT 3b期试验开放标签延长期的长期结果。
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引用本文的文献

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IRAK4 Targeting: A Breakthrough Approach to Combat Hidradenitis Suppurativa.靶向IRAK4:治疗化脓性汗腺炎的突破性方法。
Biologics. 2025 Jun 30;19:387-397. doi: 10.2147/BTT.S525106. eCollection 2025.
2
Single-Injection Options for Administering a 320 mg Dose of Bimekizumab: 2 mL Safety Syringe and Auto-injector.注射320毫克剂量的比美吉珠单抗的单次注射选择:2毫升安全注射器和自动注射器。
Dermatol Ther (Heidelb). 2025 May;15(5):1113-1134. doi: 10.1007/s13555-025-01366-6. Epub 2025 Mar 29.
3
A Guide to the Management of Hidradenitis Suppurativa in Pregnancy and Lactation.妊娠和哺乳期化脓性汗腺炎管理指南
Am J Clin Dermatol. 2025 May;26(3):345-360. doi: 10.1007/s40257-025-00935-x. Epub 2025 Mar 25.

本文引用的文献

1
Real-world effectiveness and safety of bimekizumab for hidradenitis suppurativa: An ambispective observational study.生物制剂治疗化脓性汗腺炎的真实世界疗效和安全性:一项前瞻性观察研究。
Australas J Dermatol. 2024 Nov;65(7):e198-e202. doi: 10.1111/ajd.14339. Epub 2024 Jun 19.
2
Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials.比美吉珠单抗治疗中重度化脓性汗腺炎患者的疗效和安全性(BE HEARD I 和 BE HEARD II):两项为期 48 周、随机、双盲、安慰剂对照、多中心 3 期临床试验。
Lancet. 2024 Jun 8;403(10443):2504-2519. doi: 10.1016/S0140-6736(24)00101-6. Epub 2024 May 22.
3
Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies.比美吉珠单抗治疗活动性中轴型脊柱关节炎患者的疗效和安全性:随机平行 3 期 BE MOBILE 1 和 BE MOBILE 2 研究的 52 周结果。
Ann Rheum Dis. 2024 Jan 11;83(2):199-213. doi: 10.1136/ard-2023-224803.
4
Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study-IL PSO (Italian landscape psoriasis).比美吉珠单抗治疗斑块状银屑病的有效性和安全性:一项真实世界多中心研究-IL PSO(意大利银屑病情况)
Front Med (Lausanne). 2023 Aug 8;10:1243843. doi: 10.3389/fmed.2023.1243843. eCollection 2023.
5
Genetic Variants Associated With Hidradenitis Suppurativa.与化脓性汗腺炎相关的遗传变异。
JAMA Dermatol. 2023 Sep 1;159(9):930-938. doi: 10.1001/jamadermatol.2023.2217.
6
IL-17A and IL-17F in tissue homeostasis, inflammation and regeneration.IL-17A 和 IL-17F 在组织稳态、炎症和再生中的作用。
Nat Rev Rheumatol. 2023 Sep;19(9):535-536. doi: 10.1038/s41584-023-01004-5.
7
Bimekizumab in hidradenitis suppurativa: a valid and effective emerging treatment.比美吉珠单抗治疗化脓性汗腺炎:一种有效且可行的新兴疗法。
Clin Exp Dermatol. 2023 Oct 25;48(11):1272-1274. doi: 10.1093/ced/llad229.
8
Bimekizumab treatment in patients with moderate to severe plaque psoriasis: a drug safety evaluation.中度至重度斑块状银屑病患者的比美吉珠单抗治疗:药物安全性评估
Expert Opin Drug Saf. 2023 Jan-Jun;22(5):355-362. doi: 10.1080/14740338.2023.2218086. Epub 2023 Jun 19.
9
Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial.比美吉珠单抗治疗中度至重度斑块状银屑病的疗效和安全性:随机 BE RADIANT 3b 期试验开放性扩展的两年间结果。
J Am Acad Dermatol. 2023 Sep;89(3):486-495. doi: 10.1016/j.jaad.2023.04.063. Epub 2023 May 12.
10
Bimekizumab maintenance of response through 3 years in patients with moderate-to-severe plaque psoriasis: results from the BE BRIGHT open-label extension trial.在中重度斑块型银屑病患者中,比美吉珠单抗维持治疗应答 3 年:来自 BE BRIGHT 开放性扩展试验的结果。
Br J Dermatol. 2023 May 24;188(6):749-759. doi: 10.1093/bjd/ljad035.