Efficacy and safety of eptinezumab in patients with chronic migraine and medication-overuse headache : a randomized, double-blind, placebo-controlled study
Yu, Shengyuan (Chinese PLA General Hospital)
Zhou, Jiying (The First Affiliated Hospital of Chongqing Medical University)
Luo, Guogang (The First Affiliated Hospital of Xi'an Jiaotong University)
Xiao, Zheman (Renmin Hospital of Wuhan University)
Ettrup, Anders (H. Lundbeck A/S (Copenhagen, Dinamarca))
Jansson, Gary (H. Lundbeck A/S (Copenhagen, Dinamarca))
Florea, Ioana (H. Lundbeck A/S (Copenhagen, Dinamarca))
Ranc, Kristina (H. Lundbeck A/S (Copenhagen, Dinamarca))
Pozo-Rosich, Patricia (Universitat Autònoma de Barcelona. Departament de Medicina)

Data:	2023
Resum:	For some people with migraine, despite taking greater amounts of acute headache medication (AHM), they develop an increase in monthly headache days. This cycle of increasing headache days, and in turn AHM use, can lead to a secondary headache disorder called medication-overuse headache (MOH). Preventive medications can prevent migraine from occurring and reduce reliance on AHMs, thereby preventing the cycle of MOH. This study was performed to evaluate the efficacy and safety of eptinezumab to prevent migraine/headache in a mainly Asian patient population with a dual diagnosis of chronic migraine and MOH. SUNLIGHT was a phase 3, multicenter, double-blind, parallel-group, placebo-controlled trial. Patients aged 18-75 years with ≥ 8 migraine days/month and a diagnosis of MOH were randomly allocated (1:1) to one of two treatment groups: eptinezumab 100 mg or placebo. Monthly migraine days (MMDs) were captured using a daily electronic diary; the change from baseline in the number of MMDs over Weeks 1-12 was the primary efficacy endpoint. Patients were randomized to eptinezumab 100 mg (n = 93) or placebo (n = 100). Over Weeks 1-12, eptinezumab reduced mean MMDs more than placebo (difference between treatments was -1. 2; p = 0. 1484). Differences between treatment groups with p-values below 0. 05 favoring eptinezumab were observed in 3 out of the 6 key secondary endpoints. All endpoints numerically favored eptinezumab treatment when compared to placebo; however, this study did not meet its primary endpoint and is therefore negative. No new safety signals were identified in this study, like previous reports that confirmed the safety and tolerability of eptinezumab treatment.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Chronic migraine ; Medication-overuse headache ; Anti-CGRP ; Eptinezumab ; Preventive migraine treatment
Publicat a:	BMC Neurology, Vol. 23 Núm. 1 (December 2023) , ISSN 1471-2377

DOI: 10.1186/s12883-023-03477-z
PMID: 38102535

14 p, 2.1 MB

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