Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients

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...

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Autores: Muñoz-Vendrell A, Campoy S, Caronna E, Alpuente A, Torres-Ferrus M, Nieves Castellanos C, Olivier M, Campdelacreu J, Prat J, Camiña Muñiz J, Molina Martínez FJ, Mínguez-Olaondo A, Ruibal Salgado M, Santos Lasaosa S, Navarro Pérez MP, Morollón N, López Bravo A, Cano Sánchez LM, García-Sánchez SM, García-Ull J, Rubio-Flores L, Gonzalez-Martinez A, Quintas S, Echavarría Íñiguez A, Gil Luque S, Castro-Sánchez MV, Adell Ortega V, García Alhama J, Berrocal-Izquierdo N, Belvís R, Díaz-Insa S, Pozo-Rosich P, Huerta-Villanueva M
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p17525
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/17525
Access Level:acceso abierto
Palabra clave:Calcitonin gene-related peptide
Monoclonal antibodies
Migraine
65 years old
Real-world
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spelling Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patientsMuñoz-Vendrell ACampoy SCaronna EAlpuente ATorres-Ferrus MNieves Castellanos COlivier MCampdelacreu JPrat JCamiña Muñiz JMolina Martínez FJMínguez-Olaondo ARuibal Salgado MSantos Lasaosa SNavarro Pérez MPMorollón NLópez Bravo ACano Sánchez LMGarcía-Sánchez SMGarcía-Ull JRubio-Flores LGonzalez-Martinez AQuintas SEchavarría Íñiguez AGil Luque SCastro-Sánchez MVAdell Ortega VGarcía Alhama JBerrocal-Izquierdo NBelvís RDíaz-Insa SPozo-Rosich PHuerta-Villanueva MCalcitonin gene-related peptideMonoclonal antibodiesMigraine65 years oldReal-worldBackground 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 10.17.3 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.BMC2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://incliva.portalinvestigacion.com/publicaciones/17525JOURNAL OF HEADACHE AND PAINISSN: 11292369ISSNe: 11292377reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVAinstname:INCLIVAInglésinfo:eu-repo/semantics/openAccessoai:incliva.fundanetsuite.com:p175252026-06-07T16:35:31Z
dc.title.none.fl_str_mv Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients
title Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients
spellingShingle Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients
Muñoz-Vendrell A
Calcitonin gene-related peptide
Monoclonal antibodies
Migraine
65 years old
Real-world
title_short Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients
title_full Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients
title_fullStr Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients
title_full_unstemmed Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients
title_sort Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients
dc.creator.none.fl_str_mv Muñoz-Vendrell A
Campoy S
Caronna E
Alpuente A
Torres-Ferrus M
Nieves Castellanos C
Olivier M
Campdelacreu J
Prat J
Camiña Muñiz J
Molina Martínez FJ
Mínguez-Olaondo A
Ruibal Salgado M
Santos Lasaosa S
Navarro Pérez MP
Morollón N
López Bravo A
Cano Sánchez LM
García-Sánchez SM
García-Ull J
Rubio-Flores L
Gonzalez-Martinez A
Quintas S
Echavarría Íñiguez A
Gil Luque S
Castro-Sánchez MV
Adell Ortega V
García Alhama J
Berrocal-Izquierdo N
Belvís R
Díaz-Insa S
Pozo-Rosich P
Huerta-Villanueva M
author Muñoz-Vendrell A
author_facet Muñoz-Vendrell A
Campoy S
Caronna E
Alpuente A
Torres-Ferrus M
Nieves Castellanos C
Olivier M
Campdelacreu J
Prat J
Camiña Muñiz J
Molina Martínez FJ
Mínguez-Olaondo A
Ruibal Salgado M
Santos Lasaosa S
Navarro Pérez MP
Morollón N
López Bravo A
Cano Sánchez LM
García-Sánchez SM
García-Ull J
Rubio-Flores L
Gonzalez-Martinez A
Quintas S
Echavarría Íñiguez A
Gil Luque S
Castro-Sánchez MV
Adell Ortega V
García Alhama J
Berrocal-Izquierdo N
Belvís R
Díaz-Insa S
Pozo-Rosich P
Huerta-Villanueva M
author_role author
author2 Campoy S
Caronna E
Alpuente A
Torres-Ferrus M
Nieves Castellanos C
Olivier M
Campdelacreu J
Prat J
Camiña Muñiz J
Molina Martínez FJ
Mínguez-Olaondo A
Ruibal Salgado M
Santos Lasaosa S
Navarro Pérez MP
Morollón N
López Bravo A
Cano Sánchez LM
García-Sánchez SM
García-Ull J
Rubio-Flores L
Gonzalez-Martinez A
Quintas S
Echavarría Íñiguez A
Gil Luque S
Castro-Sánchez MV
Adell Ortega V
García Alhama J
Berrocal-Izquierdo N
Belvís R
Díaz-Insa S
Pozo-Rosich P
Huerta-Villanueva M
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Calcitonin gene-related peptide
Monoclonal antibodies
Migraine
65 years old
Real-world
topic Calcitonin gene-related peptide
Monoclonal antibodies
Migraine
65 years old
Real-world
description 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 10.17.3 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.
publishDate 2023
dc.date.none.fl_str_mv 2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://incliva.portalinvestigacion.com/publicaciones/17525
url https://incliva.portalinvestigacion.com/publicaciones/17525
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BMC
publisher.none.fl_str_mv BMC
dc.source.none.fl_str_mv JOURNAL OF HEADACHE AND PAIN
ISSN: 11292369
ISSNe: 11292377
reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
instname:INCLIVA
instname_str INCLIVA
reponame_str r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
collection r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
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