比美珠单抗治疗银屑病的亚组疗效:3/3b期临床试验的事后分析

IF 4.2 3区 医学 Q1 DERMATOLOGY
Bruce Strober, Wolf-Henning Boehncke, James G Krueger, Nina Magnolo, Ronald Vender, Richard B Warren, José Manuel López Pinto, Sarah Kavanagh, Bengt Hoepken, Paolo Gisondi
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引用次数: 0

摘要

患者人口统计学、疾病特征和治疗史会影响银屑病患者生物治疗的疗效。了解bimekizumab等生物制剂在不同患者亚组中的疗效对于优化治疗结果非常重要。在这里,我们评估了在比美珠单抗治疗的中度至重度斑块性银屑病患者中观察到的高总体临床反应在亚组中是否一致,与比较组和长期治疗组相比。方法:对BE SURE、BE VIVID和BE READY 3期试验、它们的开放标签扩展(OLE) BE BRIGHT和BE RADIANT 3b期试验的数据进行事后分析。患者接受比美珠单抗或阿达木单抗治疗至第24周(BE SURE),比美珠单抗或ustekinumab治疗至第52周(BE VIVID),比美珠单抗或secukinumab治疗至第48周(BE RADIANT)。在3年的汇总分析(所有试验)中,纳入了从基线到OLE持续接受比美珠单抗治疗的患者。中度至重度斑块型银屑病患者亚组根据年龄、性别、体重、疾病持续时间、疾病严重程度、指甲受损伤(改良的指甲银屑病严重程度指数>)和既往生物暴露来定义。每个亚组中达到完全皮肤清除率的患者比例(PASI 100;银屑病面积和严重程度指数从基线改善100%)以95%置信区间(CI)报告。缺失数据采用改进的无应答者imputation (mNRI)。结果:在比较对照期后,比美珠单抗治疗患者达到PASI 100的比例在各亚组中是一致的,与接受阿达木单抗(至第24周)、ustekinumab(至第52周)和secukinumab(至第48周)治疗的患者相比,在所有亚组中,比美珠单抗治疗患者的比例更高。在连续接受比美珠单抗治疗3年的患者中(N = 1107), PASI 100反应率在不同年龄(68.6%[40至20岁])、疾病严重程度(67.7% [PASI 12至结论])保持一致:比美珠单抗在不同亚组的银屑病患者中表现出一致的高长期疗效。在所有亚组中,比美珠单抗比阿达木单抗、乌斯特金单抗和塞金单抗获得更高的PASI 100率。这些结果突出了比美珠单抗作为一种有效的治疗银屑病患者的广泛范围。试验注册号:NCT03412747、NCT03370133、NCT03410992、NCT03598790、NCT03536884。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Bimekizumab Efficacy in Psoriasis by Subgroups: Post Hoc Analysis of Phase 3/3b Clinical Trials.

Introduction: Patient demographics, disease characteristics, and treatment history can impact the efficacy of biologic treatments in patients with psoriasis. Understanding the efficacy of biologics, such as bimekizumab, across diverse patient subgroups is important for optimising treatment outcomes. Here, we assess whether high overall clinical responses observed in bimekizumab-treated patients with moderate to severe plaque psoriasis are consistent across subgroups, both versus comparators and with long-term treatment.

Methods: Data were analysed post hoc from the BE SURE, BE VIVID, and BE READY phase 3 trials, their open-label extension (OLE) BE BRIGHT, and the BE RADIANT phase 3b trial. Patients received either bimekizumab or adalimumab to week 24 (BE SURE), bimekizumab or ustekinumab to week 52 (BE VIVID), and bimekizumab or secukinumab to week 48 (BE RADIANT). In the 3-year pooled analysis (all trials), included patients received bimekizumab continuously from baseline into the OLE. Subgroups of patients with moderate to severe plaque psoriasis were defined by age, sex, weight, disease duration, disease severity, nail involvement (modified Nail Psoriasis Severity Index > 0), and prior biologic exposure, at baseline. The proportions of patients achieving complete skin clearance (PASI 100; 100% improvement from baseline in Psoriasis Area and Severity Index) in each subgroup are reported alongside 95% confidence intervals (CI). Modified non-responder imputation (mNRI) was used for missing data.

Results: Following comparator-controlled periods, the proportion of bimekizumab-treated patients who achieved PASI 100 was consistent across subgroups and numerically greater versus patients who received adalimumab (to week 24), ustekinumab (to week 52), and secukinumab (to week 48) in all subgroups. Among patients who received bimekizumab continuously for 3 years (N = 1107), PASI 100 response rates remained consistent across age (68.6% [40 to < 65 years]-73.7% [≥ 65 years]), sex (69.6% [male]-71.4% [female]), weight (63.4% [≥ 103.9 kg]-75.5% [< 74.3 kg]), disease duration (65.5% [≤ 5 years]-71.1% [> 20 years]), disease severity (67.7% [PASI 12 to < 15]-71.1% [PASI ≥ 20]), nail involvement (69.1% [yes]/71.3% [no]), and prior biologic exposure (71.7% [yes]/69.1% [no]; prior anti-TNF exposure 67.6% [yes]/70.6% [no]) subgroups; 95% CIs overlapped in all instances, indicating no meaningful differences between subgroups.

Conclusion: Bimekizumab demonstrated consistently high long-term efficacy in patients with psoriasis across diverse subgroups. Higher rates of PASI 100 were achieved with bimekizumab versus adalimumab, ustekinumab, and secukinumab, across all subgroups. These results highlight bimekizumab as an effective treatment for a broad range of people living with psoriasis.

Trial registration: NCT03412747, NCT03370133, NCT03410992, NCT03598790, NCT03536884.

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来源期刊
Dermatology and Therapy
Dermatology and Therapy Medicine-Dermatology
CiteScore
6.00
自引率
8.80%
发文量
187
审稿时长
6 weeks
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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