使用安慰剂调整间接治疗比较,Dupilumab与Lebrikizumab显示更有可能实现和维持疗效结果的改善。

IF 4.2 3区 医学 Q1 DERMATOLOGY
Sonja Ständer, Andreas Pinter, Firas G Hougeir, Patricia Guyot, Yingxin Xu, Amy H Praestgaard, Nick Freemantle, Ana B Rossi, Gaëlle Bégo-Le-Bagousse, Zhixiao Wang, Kerry Noonan, Mike Bastian
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引用次数: 0

摘要

Dupilumab和lebrikizumab在特应性皮炎(AD)临床试验中显示出疗效;然而,没有直接的比较存在。方法:采用经安慰剂调整的Bucher间接治疗比较(ITC)评估16周时的疗效结果实现(dupilumab和lebrikizumab联合局部皮质类固醇[TCS])和52周时的疗效结果维持(dupilumab和lebrikizumab单药治疗不含TCS)。第16周数据来自LIBERTY AD CHRONOS (dupilumab, n = 106;安慰剂,n = 315)和粘附(lebrikizumab, n = 145;安慰剂,n = 66)项试验。第52周的数据来自SOLO-CONTINUE (dupilumab, n = 80;安慰剂,n = 39)和ADvocate 1和2 (lebrikizumab, n = 231;安慰剂,n = 60)试验,包括在第16周湿疹面积和严重程度指数(EASI)-75或研究者整体评估(IGA)评分0/1(明确/几乎明确)较基线改善≥75%的患者。结果以95%置信区间(ci)的比值比(ORs)表示。结果:在第16周,每2周(q2w)接受dupilumab + TCS的患者达到EASI-75的可能性显着提高(OR 2.4;95% CI 1.1-5.1),峰值瘙痒数值评定量表(PP-NRS;或2.7;95% CI 1.2-6.0)与接受lebrikizumab q2w + TCS的患者相比。其他终点(IGA-0/1和皮肤生活质量指数改善≥4点)的or在数值上更倾向于dupilumab。在第52周,dupilumab q2w维持了EASI-75的显著较高OR (OR 3.5;95% CI 1.2-10.5)和lebrikizumab每4周。EASI-90 OR (OR 3.3;95% ci 1.0-11.3), iga 0/1(或3.3;95% CI 0.7-15.1), PP-NRS (OR 8.8;95% CI 0.9-84.8)在数值上支持dupilumab。结论:经安慰剂调整的Bucher ITC分析显示,dupilumab与lebrikizumab受体相比,在16周时达到疗效结果和在52周时维持疗效结果的可能性更高。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Dupilumab versus Lebrikizumab Demonstrates Greater Likelihood of Achieving and Maintaining Improvements in Efficacy Outcomes Using a Placebo-Adjusted Indirect Treatment Comparison.

Introduction: Dupilumab and lebrikizumab have demonstrated efficacy in atopic dermatitis (AD) clinical trials; however, no direct comparisons exist.

Methods: Efficacy outcome achievement (dupilumab and lebrikizumab with topical corticosteroids [TCS]) at 16 weeks and efficacy outcomes maintenance (dupilumab and lebrikizumab monotherapy without TCS) at 52 weeks were assessed using a placebo-adjusted Bucher indirect treatment comparison (ITC). Week 16 data were sourced from LIBERTY AD CHRONOS (dupilumab, n = 106; placebo, n = 315) and ADhere (lebrikizumab, n = 145; placebo, n = 66) trials. Week 52 data were sourced from SOLO-CONTINUE (dupilumab, n = 80; placebo, n = 39) and ADvocate 1 and 2 (lebrikizumab, n = 231; placebo, n = 60) trials, including patients who had achieved ≥ 75% improvement from baseline in Eczema Area and Severity Index (EASI)-75 or Investigator's Global Assessment (IGA) score 0/1 (clear/almost clear) at week 16. Results are presented as odds ratios (ORs) with 95% confidence intervals (CIs).

Results: At week 16, patients receiving dupilumab every 2 weeks (q2w) + TCS had a significantly higher likelihood of achieving EASI-75 (OR 2.4; 95% CI 1.1-5.1) and a ≥ 4-point improvement in Peak Pruritus Numeric Rating Scale (PP-NRS; OR 2.7; 95% CI 1.2-6.0) versus those receiving lebrikizumab q2w + TCS. ORs for other endpoints (IGA-0/1 and ≥ 4-point improvement in Dermatology Life Quality Index) numerically favored dupilumab. At week 52, dupilumab q2w maintained a significantly higher OR for EASI-75 (OR 3.5; 95% CI 1.2-10.5) versus lebrikizumab every 4 weeks. ORs for EASI-90 (OR 3.3; 95% CI 1.0-11.3), IGA 0/1 (OR 3.3; 95% CI 0.7-15.1), and PP-NRS (OR 8.8; 95% CI 0.9-84.8) numerically favored dupilumab.

Conclusions: Placebo-adjusted Bucher ITC analyses showed that the likelihood of achieving efficacy outcomes at 16 weeks and maintaining efficacy outcomes at 52 weeks was higher for dupilumab versus lebrikizumab recipients.

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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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