Real-World Use of Ubrogepant as Acute Treatment for Migraine with an Anti-Calcitonin Gene-Related Peptide Monoclonal Antibody: Results from COURAGE.

IF 3.9 3区医学 Q1 CLINICAL NEUROLOGY

Neurology and Therapy Pub Date : 2024-02-01 Epub Date: 2023-11-01 DOI:10.1007/s40120-023-00556-8

Richard B Lipton, Janette Contreras-De Lama, Daniel Serrano, Ella Engstrom, Nicolai D Ayasse, Weijie Poh, François Cadiou, Aubrey Manack Adams

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引用次数: 0

Abstract

Introduction: Although acute and preventive treatments for migraine are commonly given in combination, data on the real-world effectiveness of ubrogepant as an acute treatment when used with an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (with or without onabotulinumtoxinA) are limited. This analysis sought to evaluate the real-world effectiveness, treatment satisfaction, and optimization of ubrogepant for the acute treatment of migraine when used in combination with an anti-CGRP monoclonal antibody, with or without concomitant onabotulinumtoxinA.

Methods: This prospective, multiple-attack, open-label, observational study (COURAGE) assessed meaningful pain relief (MPR), return to normal function (RNF), treatment satisfaction, and acute treatment optimization of ubrogepant (50 or 100 mg) when combined with an anti-CGRP monoclonal antibody, onabotulinumtoxinA, or both in adult users of Migraine Buddy, a migraine tracking application.

Results: In the ubrogepant and anti-CGRP monoclonal antibody arm (n = 245), following the first ubrogepant-treated attack, 61.6% (151/245) and 80.4% (197/245) of ubrogepant-treated participants achieved MPR at 2 and 4 h post-dose, respectively, and 34.7% (85/245) and 55.5% (136/245) achieved RNF at 2 and 4 h post-dose, respectively. Across up to 10 ubrogepant-treated attacks (N = 1153), MPR was achieved in 51.3% (592/1153) and 73.5% (847/1153) at 2 and 4 h post-dose, respectively. RNF was achieved by 32.2% (371/1153) and 53.2% (613/1153) at 2 and 4 h post-dose. After 30 days, 72.7% (168/231) of participants reported satisfaction (using a 7-point scale) with ubrogepant when used in combination with an anti-CGRP monoclonal antibody, and 79.7% (184/231) of participants achieved acute treatment optimization (defined as moderate-maximum treatment efficacy using the Migraine Treatment Optimization Questionnaire-4).

Conclusion: Real-world ubrogepant use with an anti-CGRP monoclonal antibody was associated with MPR, RNF, satisfaction, and acute treatment optimization.

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Ubrogepant与抗降钙素基因相关肽单克隆抗体在偏头痛急性治疗中的实际应用：来自COURAGE的结果。

引言：尽管偏头痛的急性和预防性治疗通常是联合使用的，但与抗降钙素基因相关肽（CGRP）单克隆抗体（含或不含onabotulinumtoxinA）一起使用时，关于优百帕作为急性治疗的真实有效性的数据有限。这项分析试图评估ubrogepant与抗CGRP单克隆抗体联合使用时，无论是否伴有奥那肉毒杆菌毒素A，对偏头痛急性治疗的真实有效性、治疗满意度和优化。方法：这项前瞻性、多次发作、开放标签、观察性研究（COURAGE）评估了有意义的疼痛缓解（MPR），在偏头痛追踪应用Migraine Buddy的成年用户中，与抗CGRP单克隆抗体onabotulinumtoxinA或两者联合使用时，ubrogepant（50或100 mg）的恢复正常功能（RNF）、治疗满意度和急性治疗优化。结果：抗CGRP单克隆抗体组（n = 245），在第一次接受奥巴西泮治疗的发作后，分别有61.6%（151/245）和80.4%（197/245）的奥巴西坦治疗的参与者在给药后2和4小时实现了MPR，34.7%（85/245），55.5%（136/245）在给药前2和4 h实现了RNF。在多达10次使用副保护剂治疗的攻击中（N = 1153），MPR在给药后2小时和4小时分别达到51.3%（592/1153）和73.5%（847/1153）。RNF在给药后2和4小时分别达到32.2%（371/1153）和53.2%（613/1153）。30天后，72.7%（168/231）的参与者报告称，当与抗CGRP单克隆抗体联合使用时，对优培坦感到满意（使用7分量表），79.7%（184/231）的参与者实现了急性治疗优化（使用偏头痛治疗优化问卷-4定义为中等最大治疗效果）。结论：在现实世界中使用抗CGRP单克隆抗体与MPR、RNF、满意度和急性治疗优化有关。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Neurology and Therapy CLINICAL NEUROLOGY-

CiteScore

5.40

自引率

8.10%

发文量

103

审稿时长

6 weeks

期刊介绍： Aims and Scope Neurology and Therapy aims to provide reliable and inclusive, rapid publication for all therapy related research for neurological indications, supporting the timely dissemination of research with a global reach, to help advance scientific discovery and support clinical practice. Neurology and Therapy is an international, open access, peer reviewed, rapid publication 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 neurological and psychiatric therapies, (also covering surgery and devices). Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial designs, communications and letters. 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