Dupilumab治疗中重度特应性皮炎成人患者最佳瘙痒反应的发作和长期维持:两项3期试验的事后分析

IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Sonja Ständer, Gil Yosipovitch, Eric L. Simpson, Brian S. Kim, Kenji Kabashima, Diamant Thaçi, Martin Metz, Zhen Chen, Sandra Hagen, Mike Bastian
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引用次数: 0

摘要

从治疗到目标的概念建立了目标,以指导特应性皮炎(AD)的全身治疗,包括瘙痒改善的目标,据报道,瘙痒是最严重的症状。本研究的目的是评估使用dupilumumab治疗的患者的最佳瘙痒反应开始和长期维持标准。方法:这项事后分析评估了两项3期随机、双盲、安慰剂对照研究中≥18岁的中重度AD患者。患者接受dupilumab 300 mg / 2周或安慰剂联合局部皮质类固醇(TCS)治疗52周(CHRONOS);或dupilumab单药治疗300mg /周/每2周/每4周/每8周或安慰剂治疗36周后,dupilumab在SOLO1/2 (SOLO-CONTINUE)中达到75%的湿疹面积和严重程度指数改善或研究者的全球评估0/1。最佳瘙痒反应定义为峰值瘙痒数值评定量表≤4。结果:与接受安慰剂+ TCS的患者相比,接受dupilumab + TCS的患者获得最佳瘙痒反应的速度更快,比例更高(P)结论:在接受dupilumab治疗或不接受TCS治疗的成人患者中,获得最佳瘙痒反应的速度很快,并且长期维持。试验注册:NCT02395133和NCT02260986。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Onset and Long-Term Maintenance of Optimal Itch Response in Adult Patients with Moderate-to-Severe Atopic Dermatitis Treated with Dupilumab: Post Hoc Analysis from Two Phase 3 Trials

Introduction

The treat-to-target concept established goals to guide treatment with systemic therapies in atopic dermatitis (AD), including goals for itch improvement, reported as the most burdensome symptom. The aim of this study is to assess optimal itch response onset and long-term maintenance using treat-to-target criteria in dupilumab-treated patients.

Methods

This post hoc analysis assessed patients ≥ 18 years with moderate-to-severe AD in two phase 3, randomized, double-blind, placebo-controlled studies. Patients received dupilumab 300 mg every 2 weeks or placebo with concomitant topical corticosteroids (TCS) for 52 weeks (CHRONOS); or dupilumab monotherapy 300 mg every week/every 2 weeks/every 4 weeks/every 8 weeks or placebo for 36 weeks after achieving Eczema Area and Severity Index improvement of 75% or Investigator’s Global Assessment 0/1 with dupilumab in SOLO1/2 (SOLO-CONTINUE). Optimal itch response was defined as Peak Pruritus Numeric Rating Scale ≤ 4.

Results

Patients receiving dupilumab + TCS achieved optimal itch response faster and in higher proportion than those receiving placebo + TCS (P < 0.0001) and maintained optimal response longer (median [Q1–Q3] 40 [11–50] vs 3 [0–23] weeks; P < 0.0001). Patients achieving optimal itch response with dupilumab monotherapy who continued treatment maintained response longer compared with those transitioned to placebo, although duration decreased with less frequent dosing (P < 0.0001 for all dupilumab regimens vs placebo).

Conclusion

Optimal itch response was achieved rapidly and maintained long term in adult patients treated with dupilumab with or without concomitant TCS therapy.

Trial Registration

NCT02395133 and NCT02260986.

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来源期刊
Advances in Therapy
Advances in Therapy 医学-药学
CiteScore
7.20
自引率
2.60%
发文量
353
审稿时长
6-12 weeks
期刊介绍: Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in 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 all scientifically and ethically sound research.
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