Sistema de Salut de Catalunya
Institut Català de la Salut
[Yu S] Department of Neurology, Chinese PLA General Hospital, Beijing, China. [Zhou J] Department of Neurology, The First Afliated Hospital of Chongqing Medical University, Chongqing, China. [Luo G] Neurology Department, The First Afliated Hospital of Xi’an Jiaotong University, Xi’an, China. [Xiao Z] Department of Neurology, Renmin Hospital of Wuhan University, Wuhan, China. [Ettrup A, Jansson G] H. Lundbeck A/S, Copenhagen, Denmark. [Pozo Rosich P] Servei de Neurologia, Unitat de Cefalea, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Grup de Recerca de Cefalea i Dolor Neurològic, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain
Vall d'Hebron Barcelona Hospital Campus
2024-01-08T10:45:31Z
2024-01-08T10:45:31Z
2023-12-15
Chronic migraine; Eptinezumab; Preventive migraine treatment
Migranya crònica; Eptinezumab; Tractament preventiu de la migranya
Migraña crónica; Eptinezumab; Tratamiento preventivo de la migraña
Background 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. Methods 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. Results 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. Conclusion 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. Trial registration ClinicalTrials.gov identifier: NCT04772742 (26/02/2021).
The study and medical writing support for the development of the manuscript was sponsored and funded by H. Lundbeck A/S (Copenhagen, Denmark).
Article
Published version
English
Avaluació de resultats (Assistència sanitària); Anticossos monoclonals - Ús terapèutic; Migranya - Tractament; CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome; DISEASES::Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Headache Disorders::Headache Disorders, Primary::Migraine Disorders; COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento; ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos con cefaleas::cefaleas primarias::trastornos migrañosos
BMC
BMC Neurology;23
https://doi.org/10.1186/s12883-023-03477-z
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
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