Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients
- PMID: 37268904
- PMCID: PMC10236648
- DOI: 10.1186/s10194-023-01585-2
Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients
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.
Keywords: 65 years old; Calcitonin gene-related peptide; Migraine; Monoclonal antibodies; Real-world.
© 2023. The Author(s).
Conflict of interest statement
AMV, SC, JC and JP have received honoraria from Teva, Lilly, Roche, UCB, Bial, Chiesi, Allergan, Esai, Zambon, Kern Pharma, Pfizer, Biogen Idec, Novartis, TEVA, Merck, Janssen, Neuraxpharm, Genzyme, Sanofi, Bayer, Almirall and/or Celgene.
EC has received honoraria from Novartis, Chiesi, Lundbeck, Medscape. He is junior editor for Cephalalgia.
Marta Torres-Ferrus has received honoraria as a consultant or speaker for Allergan-Abbvie, Almirall, Chiesi, Eli Lilly, Novartis, and Teva.
Alicia Alpuente has received honoraria as speaker from Abbvie and for education from Novartis and Eli Lilly.
CN has received honoraria from Lilly, Novartis, Teva and Chiesi.
JCM has received honoraria from Lilly, Novartis, Teva, Abbvie-Allergan, Lundbeck, Chiesi, Bial, Neuraxpharm, Schwabe. FJMM has received honoraria from Lilly, Novartis, Teva, Abbvie-Allergan y Chiesi.
AMO has received honoraria from Lilly, Novartis, Allergan-Abbvie, Bial, Eisai, Grünenthal, Almirall or Neuraxpharm.
SSL has received honoraria from Allergan, Amgen, Chiesi, Eisai, Exeltis, Novartis, and Teva.
NM has received honoraria from Teva, Novartis, Lilly and Abbvie.
LMCS and SMGS have received honoraria from Lilly and Teva.
AGM has received education funding from Lilly, Novartis, Roche, TEVA, Abbvie-Allergan, & Daichi and speaker honoraria from TEVA.
NBI has received honoraria from Zambon, Actelion, Lilly and Teva.
RB has received honoraria from Abbvie, Neuraxpharma, Abbott, Teva, Novartis, Pfizer, Lilly, Almirall, Noema, Exeltis, Ergon, Neurodiem, Menarini, Biogen, Lundbeck and Medtronik.
SD has received honoraria from Abbvie, Ipsen, Lilly, Lundbeck, Novartis and Teva.
P.P.R. has received honoraria as a consultant and speaker, in the last three years, for: AbbVie, Amgen, Biohaven, Chiesi, Eli Lilly, Lundbeck, Medscape, Novartis, Pfizer and Teva. Her research group has received research grants from AbbVie, Novartis and Teva; and, has received funding for clinical trials from Alder, AbbVie, Amgen, Biohaven, Electrocore, Eli Lilly, Lundbeck, Novartis and Teva. She is the Honorary Secretary of the International Headache Society. She is in the editorial board of Revista de Neurologia, associate editor for Cephalalgia, Headache, Neurologia, Frontiers of Neurology. She is a member of the Clinical Trials Guidelines Committee and Scientific Committee of the International Headache Society. She has edited the Guidelines for the Diagnosis and Treatment of Headache of the Spanish Neurological Society. She is the founder of
MH-V has received honoraria for participating on advisory boards and for collaborations as consultant, scientific communications, speaker, research support as well as funding for travel and congress-attending expenses for Abbie-Allergan, Novartis, Lilly, Almirall, Chiesi, Esai, Exeltis, Kern Pharma, Menarini, TEVA and Zambon. His research group has received research grants from Abbie-Allergan; and has received funding for clinical trials from Lilly, Novartis, TEVA.
MO, MRS, MPNP, ALB, JGU, LRF, SQ, AEI, SGL, MVCS, VAO and JGA have nothing to disclose.
Figures
