Abstract

Background

Anti-CGRP monoclonal antibodies have shown notable effectiveness and tolerability in migraine patients; however, data on their use in elderly patients is still lacking, as clinical trials have implicit age restrictions and real-world evidence is scarce. In this study, we aimed to describe the safety and effectiveness of erenumab, galcanezumab and fremanezumab in migraine patients over 65 years old in real-life.

Methods

In this observational real-life study, a retrospective analysis of prospectively collected data from 18 different headache units in Spain was performed. Migraine patients who started treatment with any anti-CGRP monoclonal antibody after the age of 65 years were included. Primary endpoints were reduction in monthly migraine days after 6 months of treatment and the presence of adverse effects. Secondary endpoints were reductions in headache and medication intake frequencies by months 3 and 6, response rates, changes in patient-reported outcomes and reasons for discontinuation. As a subanalysis, reduction in monthly migraine days and proportion of adverse effects were also compared among the three monoclonal antibodies.

Results

A total of 162 patients were included, median age 68 years (range 65–87), 74.1% women. 42% had dyslipidaemia, 40.3% hypertension, 8% diabetes, and 6.2% previous cardiovascular ischaemic disease. The reduction in monthly migraine days at month 6 was 10.1 ± 7.3 days. A total of 25.3% of patients presented adverse effects, all of them mild, with only two cases of blood pressure increase. Headache and medication intake frequencies were significantly reduced, and patient-reported outcomes were improved. The proportions of responders were 68%, 57%, 33% and 9% for reductions in monthly migraine days ≥ 30%, ≥ 50%, ≥ 75% and 100%, respectively. A total of 72.8% of patients continued with the treatment after 6 months. The reduction in migraine days was similar for the different anti-CGRP treatments, but fewer adverse effects were detected with fremanezumab (7.7%).

Conclusions

Anti-CGRP mAbs are safe and effective treatments in migraine patients over 65 years old in real-life clinical practice.

Details

Title
Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients
Author
Muñoz-Vendrell, Albert 1 ; Campoy, Sergio 2 ; Caronna, Edoardo 3 ; Alpuente, Alicia 3 ; Torres-Ferrus, Marta 3 ; Nieves Castellanos, Candela 4 ; Olivier, Marina 4 ; Campdelacreu, Jaume 1 ; Prat, Joan 1 ; Camiña Muñiz, Javier 5 ; Molina Martínez, Francisco José 6 ; Mínguez-Olaondo, Ane 7 ; Ruibal Salgado, Marta 8 ; Santos Lasaosa, Sonia 9 ; Navarro Pérez, María Pilar 9 ; Morollón, Noemí 10 ; López Bravo, Alba 11 ; Cano Sánchez, Luis Miguel 12 ; García-Sánchez, Sonia María 12 ; García-Ull, Jésica 13 ; Rubio-Flores, Laura 14 ; Gonzalez-Martinez, Alicia 15 ; Quintas, Sonia 15 ; Echavarría Íñiguez, Ana 16 ; Gil Luque, Sendoa 17 ; Castro-Sánchez, María Victoria 18 ; Adell Ortega, Vanesa 19 ; García Alhama, Jessica 19 ; Berrocal-Izquierdo, Nuria 20 ; Belvís, Robert 10 ; Díaz-Insa, Samuel 4 ; Pozo-Rosich, Patricia 3 ; Huerta-Villanueva, Mariano 2 

 Hospital Universitari de Bellvitge-IDIBELL, Universitat de Barcelona, L’Hospitalet de Llobregat, Neurology Department, Barcelona, Spain (GRID:grid.5841.8) (ISNI:0000 0004 1937 0247) 
 Hospital Universitari de Bellvitge-IDIBELL, Universitat de Barcelona, L’Hospitalet de Llobregat, Neurology Department, Barcelona, Spain (GRID:grid.5841.8) (ISNI:0000 0004 1937 0247); Hospital de Viladecans-IDIBELL, Neurology Department, Barcelona, Spain (GRID:grid.459594.0) (ISNI:0000 0004 1767 5311) 
 Hospital Universitari Vall d’Hebron, Headache Unit, Neurology Department, Barcelona, Spain (GRID:grid.411083.f) (ISNI:0000 0001 0675 8654); Universitat Autònoma de Barcelona, Headache and Neurological Pain Research Group, Vall d’Hebron Research Institute, Department of Medicine, Barcelona, Spain (GRID:grid.7080.f) (ISNI:0000 0001 2296 0625) 
 Unidad de Cefaleas. Servicio de Neurología, Hospital Universitari I Politécnic La Fe, Valencia, Spain (GRID:grid.84393.35) (ISNI:0000 0001 0360 9602) 
 Unidad de Cefaleas. Servicio de Neurología, Hospital Universitari Son Espases, Palma, Spain (GRID:grid.411164.7) (ISNI:0000 0004 1796 5984); Consulta Monográfica de Cefaleas. Clínica Rotger Quirónsalud, Palma, Spain (GRID:grid.497607.b) (ISNI:0000 0004 1808 0870) 
 Unidad de Cefaleas. Servicio de Neurología, Hospital Universitari Son Espases, Palma, Spain (GRID:grid.411164.7) (ISNI:0000 0004 1796 5984) 
 Donostia University Hospital-OSAKIDETZA, Neurology Department, San Sebastián, Spain (GRID:grid.414651.3) (ISNI:0000 0000 9920 5292); ATHENEA Neuroclinics, Policlínica Gipuzkoa Grupo Quironsalud, Donostia, Spain (GRID:grid.429915.2) (ISNI:0000 0004 1794 0058); University of Deusto, Department of Medicine, Faculty of Health Sciences, Bilbao, Spain (GRID:grid.14724.34) (ISNI:0000 0001 0941 7046); Biodonostia Research Institute, Neuroscience Area, San Sebastián, Spain (GRID:grid.432380.e) 
 Donostia University Hospital-OSAKIDETZA, Neurology Department, San Sebastián, Spain (GRID:grid.414651.3) (ISNI:0000 0000 9920 5292); Biodonostia Research Institute, Neuroscience Area, San Sebastián, Spain (GRID:grid.432380.e) 
 Unidad de Cefaleas. Servicio de Neurología, Hospital Clínico Universitario Lozano Blesa, IIS Aragon, Zaragoza, Spain (GRID:grid.411050.1) (ISNI:0000 0004 1767 4212) 
10  Unidad de Cefaleas Y Neuralgias. Servicio de Neurología. Hospital de La Santa Creu I Sant Pau, Barcelona, Spain (GRID:grid.413396.a) (ISNI:0000 0004 1768 8905) 
11  Unidad de Cefaleas. Sección de Neurología, Hospital Reina Sofía. Instituto de Investigación Sanitaria de Aragón (IIS-A), Tudela, Spain (GRID:grid.411349.a) (ISNI:0000 0004 1771 4667) 
12  Servicio de Neurología. Hospital Sant Joan Despí. Consorci Sanitari Integral, Sant Joan Despí, Spain (GRID:grid.411349.a) 
13  Unidad de Cefaleas. Servicio de Neurología, Hospital Clínico Universitario de Valencia, Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain (GRID:grid.411308.f) 
14  Servicio de Neurología. Hospital Universitario General de Villalba, Madrid, Spain (GRID:grid.411308.f) 
15  Hospital Universitario de La Princesa E Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Headache Unit, Neurology Department, Madrid, Spain (GRID:grid.411251.2) (ISNI:0000 0004 1767 647X) 
16  Unidad de Cefaleas, Hospital Clínico Universitario de Valladolid, Valladolid, Spain (GRID:grid.411057.6) (ISNI:0000 0000 9274 367X) 
17  Servicio de Neurología. Hospital Universitario de Burgos, Burgos, Spain (GRID:grid.459669.1) (ISNI:0000 0004 1771 1036) 
18  Servicio de Neurología. Hospital Carlos Haya de Málaga, Málaga, Spain (GRID:grid.411457.2) 
19  Servei de Neurologia. Consorci Sanitari de L’Alt Penedès-Garraf, Barcelona, Spain (GRID:grid.411457.2) 
20  Parc Sanitari Sant Joan de Déu. Servicio de Neurología. Sant Boi de Llobregat, Barcelona, Spain (GRID:grid.466982.7) (ISNI:0000 0004 1771 0789) 
Pages
63
Publication year
2023
Publication date
Dec 2023
Publisher
Springer Nature B.V.
ISSN
11292369
e-ISSN
11292377
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2821743271
Copyright
© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.