MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention
BackgroundErenumab was approved in Europe for migraine prevention in patients with >= 4 monthly migraine days (MMDs). In Spain, Novartis started a personalized managed access program, which allowed free access to erenumab before official reimbursement. The Spanish Neurological Society started a p...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Fecha de publicación: | 2021 |
| País: | España |
| Institución: | Conselleria de Salut i Consum del Govern de les Illes Balears |
| Repositorio: | Docusalut |
| Idioma: | inglés |
| OAI Identifier: | oai:docusalut.com:20.500.13003/19676 |
| Acceso en línea: | https://hdl.handle.net/20.500.13003/19676 |
| Access Level: | acceso abierto |
| Palabra clave: | Migraine Disorders Europe Spain Female Humans Antibodies, Monoclonal, Humanized Registries Middle Aged Humanos Persona de Mediana Edad Trastornos Migrañosos Femenino Europa (Continente) Anticuerpos Monoclonales Humanizados España Sistema de Registros Erenumab Migraine Monoclonal antibody Preventive treatment Registry |
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MAB-MIG: registry of the spanish neurological society of erenumab for migraine preventionBelvis Nieto, RobertIrimia, PabloPozo-Rosich, PatriciaGonzalez-Oria, CarmenCano, AntonioViguera, JavierSánchez, BelénMolina, FranciscoBeltrán, IsabelOterino, AgustinCuadrado, ElisaGomez-Camello, AngelAlberte-Woodward, MiguelJurado, CarmenOms, TeresaEzpeleta, DavidDiaz de Teran, JavierMorollon, NoemiLatorre, GermanTorres-Ferrus, MartaAlpuente, AliciaLamas, RaquelToledano, CarlosLeira, RogelioSantos, SoniaSanchez del Rio, MargaritaMigraine DisordersEuropeSpainFemaleHumansAntibodies, Monoclonal, HumanizedRegistriesMiddle AgedHumanosPersona de Mediana EdadTrastornos MigrañososFemeninoEuropa (Continente)Anticuerpos Monoclonales HumanizadosEspañaSistema de RegistrosErenumabMigraineMonoclonal antibodyPreventive treatmentRegistryBackgroundErenumab was approved in Europe for migraine prevention in patients with >= 4 monthly migraine days (MMDs). In Spain, Novartis started a personalized managed access program, which allowed free access to erenumab before official reimbursement. The Spanish Neurological Society started a prospective registry to evaluate real-world effectiveness and tolerability, and all Spanish headache experts were invited to participate. We present their first results.MethodsPatients fulfilled the ICHD-3 criteria for migraine and had >= 4 MMDs. Sociodemographic and clinical data were registered as well as MMDs, monthly headache days, MHDs, prior and concomitant preventive treatment, medication overuse headache (MOH), migraine evolution, adverse events, and patient-reported outcomes (PROs): headache impact test (HIT-6), migraine disability assessment questionnaire (MIDAS), and patient global improvement change (PGIC). A>50% reduction of MMDs after 12 weeks was considered as a response.ResultsWe included 210 patients (female 86.7%, mean age 46.4 years old) from 22 Spanish hospitals from February 2019 to June 2020. Most patients (89.5%) suffered from chronic migraine with a mean evolution of 8.6 years. MOH was present in 70% of patients, and 17.1% had migraine with aura. Patients had failed a mean of 7.8 preventive treatments at baseline (botulinum toxin type A-BoNT/A-had been used by 95.2% of patients). Most patients (67.6%) started with erenumab 70 mg. Sixty-one percent of patients were also simultaneously taking oral preventive drugs and 27.6% were getting simultaneous BoNT/A. Responder rate was 37.1% and the mean reduction of MMDs and MHDs was -6.28 and -8.6, respectively. Changes in PROs were: MIDAS: -35 points, HIT-6: -11.6 points, PIGC: 4.7 points. Predictors of good response were prior HIT-6 score<80 points (p=0.01),<less than or equal to>5 prior preventive treatment failures (p=0.026), absence of MOH (p=0.039), and simultaneous BoNT/A treatment (p<0.001). Twenty percent of patients had an adverse event, but only two of them were severe (0.9%), which led to treatment discontinuation. Mild constipation was the most frequent adverse event (8.1%).ConclusionsIn real-life, in a personalized managed access program, erenumab shows a good effectiveness profile and an excellent tolerability in migraine prevention in our cohort of refractory patients.BMC20212021-12-0120212021-12-01research articlehttp://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/20.500.13003/19676reponame:Docusalutinstname:Conselleria de Salut i Consum del Govern de les Illes BalearsInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:docusalut.com:20.500.13003/196762026-06-22T12:44:07Z |
| dc.title.none.fl_str_mv |
MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention |
| title |
MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention |
| spellingShingle |
MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention Belvis Nieto, Robert Migraine Disorders Europe Spain Female Humans Antibodies, Monoclonal, Humanized Registries Middle Aged Humanos Persona de Mediana Edad Trastornos Migrañosos Femenino Europa (Continente) Anticuerpos Monoclonales Humanizados España Sistema de Registros Erenumab Migraine Monoclonal antibody Preventive treatment Registry |
| title_short |
MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention |
| title_full |
MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention |
| title_fullStr |
MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention |
| title_full_unstemmed |
MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention |
| title_sort |
MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention |
| dc.creator.none.fl_str_mv |
Belvis Nieto, Robert Irimia, Pablo Pozo-Rosich, Patricia Gonzalez-Oria, Carmen Cano, Antonio Viguera, Javier Sánchez, Belén Molina, Francisco Beltrán, Isabel Oterino, Agustin Cuadrado, Elisa Gomez-Camello, Angel Alberte-Woodward, Miguel Jurado, Carmen Oms, Teresa Ezpeleta, David Diaz de Teran, Javier Morollon, Noemi Latorre, German Torres-Ferrus, Marta Alpuente, Alicia Lamas, Raquel Toledano, Carlos Leira, Rogelio Santos, Sonia Sanchez del Rio, Margarita |
| author |
Belvis Nieto, Robert |
| author_facet |
Belvis Nieto, Robert Irimia, Pablo Pozo-Rosich, Patricia Gonzalez-Oria, Carmen Cano, Antonio Viguera, Javier Sánchez, Belén Molina, Francisco Beltrán, Isabel Oterino, Agustin Cuadrado, Elisa Gomez-Camello, Angel Alberte-Woodward, Miguel Jurado, Carmen Oms, Teresa Ezpeleta, David Diaz de Teran, Javier Morollon, Noemi Latorre, German Torres-Ferrus, Marta Alpuente, Alicia Lamas, Raquel Toledano, Carlos Leira, Rogelio Santos, Sonia Sanchez del Rio, Margarita |
| author_role |
author |
| author2 |
Irimia, Pablo Pozo-Rosich, Patricia Gonzalez-Oria, Carmen Cano, Antonio Viguera, Javier Sánchez, Belén Molina, Francisco Beltrán, Isabel Oterino, Agustin Cuadrado, Elisa Gomez-Camello, Angel Alberte-Woodward, Miguel Jurado, Carmen Oms, Teresa Ezpeleta, David Diaz de Teran, Javier Morollon, Noemi Latorre, German Torres-Ferrus, Marta Alpuente, Alicia Lamas, Raquel Toledano, Carlos Leira, Rogelio Santos, Sonia Sanchez del Rio, Margarita |
| 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 |
| dc.contributor.none.fl_str_mv |
|
| dc.subject.none.fl_str_mv |
Migraine Disorders Europe Spain Female Humans Antibodies, Monoclonal, Humanized Registries Middle Aged Humanos Persona de Mediana Edad Trastornos Migrañosos Femenino Europa (Continente) Anticuerpos Monoclonales Humanizados España Sistema de Registros Erenumab Migraine Monoclonal antibody Preventive treatment Registry |
| topic |
Migraine Disorders Europe Spain Female Humans Antibodies, Monoclonal, Humanized Registries Middle Aged Humanos Persona de Mediana Edad Trastornos Migrañosos Femenino Europa (Continente) Anticuerpos Monoclonales Humanizados España Sistema de Registros Erenumab Migraine Monoclonal antibody Preventive treatment Registry |
| description |
BackgroundErenumab was approved in Europe for migraine prevention in patients with >= 4 monthly migraine days (MMDs). In Spain, Novartis started a personalized managed access program, which allowed free access to erenumab before official reimbursement. The Spanish Neurological Society started a prospective registry to evaluate real-world effectiveness and tolerability, and all Spanish headache experts were invited to participate. We present their first results.MethodsPatients fulfilled the ICHD-3 criteria for migraine and had >= 4 MMDs. Sociodemographic and clinical data were registered as well as MMDs, monthly headache days, MHDs, prior and concomitant preventive treatment, medication overuse headache (MOH), migraine evolution, adverse events, and patient-reported outcomes (PROs): headache impact test (HIT-6), migraine disability assessment questionnaire (MIDAS), and patient global improvement change (PGIC). A>50% reduction of MMDs after 12 weeks was considered as a response.ResultsWe included 210 patients (female 86.7%, mean age 46.4 years old) from 22 Spanish hospitals from February 2019 to June 2020. Most patients (89.5%) suffered from chronic migraine with a mean evolution of 8.6 years. MOH was present in 70% of patients, and 17.1% had migraine with aura. Patients had failed a mean of 7.8 preventive treatments at baseline (botulinum toxin type A-BoNT/A-had been used by 95.2% of patients). Most patients (67.6%) started with erenumab 70 mg. Sixty-one percent of patients were also simultaneously taking oral preventive drugs and 27.6% were getting simultaneous BoNT/A. Responder rate was 37.1% and the mean reduction of MMDs and MHDs was -6.28 and -8.6, respectively. Changes in PROs were: MIDAS: -35 points, HIT-6: -11.6 points, PIGC: 4.7 points. Predictors of good response were prior HIT-6 score<80 points (p=0.01),<less than or equal to>5 prior preventive treatment failures (p=0.026), absence of MOH (p=0.039), and simultaneous BoNT/A treatment (p<0.001). Twenty percent of patients had an adverse event, but only two of them were severe (0.9%), which led to treatment discontinuation. Mild constipation was the most frequent adverse event (8.1%).ConclusionsIn real-life, in a personalized managed access program, erenumab shows a good effectiveness profile and an excellent tolerability in migraine prevention in our cohort of refractory patients. |
| publishDate |
2021 |
| dc.date.none.fl_str_mv |
2021 2021-12-01 2021 2021-12-01 |
| dc.type.none.fl_str_mv |
research article http://purl.org/coar/resource_type/c_2df8fbb1 |
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info:eu-repo/semantics/article |
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article |
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https://hdl.handle.net/20.500.13003/19676 |
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https://hdl.handle.net/20.500.13003/19676 |
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Inglés eng |
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Inglés |
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eng |
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open access http://purl.org/coar/access_right/c_abf2 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ |
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BMC |
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BMC |
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