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ubrogepant联合抗降钙素基因相关肽单克隆抗体用于偏头痛急性治疗的真实世界应用:COURAGE研究结果

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

作者信息

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

机构信息

Albert Einstein College of Medicine, Bronx, NY, USA.

Therapeutic Neurotoxins & Migraine, US Medical Affairs, AbbVie, 2525 Dupont Dr, Irvine, CA, 92612, USA.

出版信息

Neurol Ther. 2024 Feb;13(1):69-83. doi: 10.1007/s40120-023-00556-8. Epub 2023 Nov 1.

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.

摘要

引言

尽管偏头痛的急性治疗和预防性治疗通常联合使用,但关于ubrogepant与抗降钙素基因相关肽(CGRP)单克隆抗体(联合或不联合A型肉毒毒素)联合使用时作为急性治疗的实际疗效的数据有限。本分析旨在评估ubrogepant与抗CGRP单克隆抗体联合使用(联合或不联合A型肉毒毒素)用于偏头痛急性治疗时的实际疗效、治疗满意度和优化情况。

方法

这项前瞻性、多发作、开放标签的观察性研究(COURAGE)评估了偏头痛追踪应用程序Migraine Buddy的成年用户在将ubrogepant(50或100毫克)与抗CGRP单克隆抗体、A型肉毒毒素或两者联合使用时的有意义疼痛缓解(MPR)、恢复正常功能(RNF)、治疗满意度和急性治疗优化情况。

结果

在ubrogepant与抗CGRP单克隆抗体组(n = 245)中,在首次接受ubrogepant治疗的发作后,分别有61.6%(151/245)和80.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b56/10787718/8dc31ac11278/40120_2023_556_Fig1_HTML.jpg

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