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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.
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1 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)
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 de Viladecans-IDIBELL, Neurology Department, Barcelona, Spain (GRID:grid.459594.0) (ISNI:0000 0004 1767 5311)
3 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)
4 Unidad de Cefaleas. Servicio de Neurología, Hospital Universitari I Politécnic La Fe, Valencia, Spain (GRID:grid.84393.35) (ISNI:0000 0001 0360 9602)
5 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)
6 Unidad de Cefaleas. Servicio de Neurología, Hospital Universitari Son Espases, Palma, Spain (GRID:grid.411164.7) (ISNI:0000 0004 1796 5984)
7 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)
8 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)
9 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)