Long-term safety of OnabotulinumtoxinA treatment in chronic migraine patients

Background: Real-world studies have shown the sustained therapeutic effect and favourable safety profile of OnabotulinumtoxinA (BoNTA) in the long term and up to 4 years of treatment in chronic migraine (CM). This study aims to assess the safety profile and efficacy of BoNTA in CM after 5 years of t...

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Detalles Bibliográficos
Autores: Navarro Pérez, María Pilar|||0000-0001-6370-218X, González-Quintanilla, V., Muñoz-Vendrell, Albert|||0000-0001-8221-865X, Madrigal, E., Alpuente, Alicia|||0000-0001-5296-9401, Latorre, G., Molina, F., Monzón, M.J., Medrano, V., Garcia Azorin, David|||0000-0002-3132-1064, González-Oria, Carmen|||0000-0002-7864-6165, Gago-Veiga, Ana Beatriz|||0000-0002-0038-3406, Velasco, F., Beltrán, Isabel, Morollón, N., Viguera, J., Casas-Limón, J., Rodríguez-Vico, J., Cuadrado Godia, Elisa|||0000-0002-9147-875X, Irimia, Pablo|||0000-0002-7238-0036, Iglesias, F., Guerrero-Peral, Ángel L., Belvís, Roberto|||0000-0002-2137-180X, Pozo-Rosich, Patricia|||0000-0003-0796-4702, Pascual, J., Santos-Lasaosa, S.
Tipo de recurso: artículo
Fecha de publicación:2024
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:307618
Acceso en línea:https://ddd.uab.cat/record/307618
https://dx.doi.org/urn:doi:10.3389/fneur.2024.1417831
Access Level:acceso abierto
Palabra clave:OnabotulinumtoxinA
Chronic migraine
Migraine
Prevention
Prophylaxis
Treatment
Descripción
Sumario:Background: Real-world studies have shown the sustained therapeutic effect and favourable safety profile of OnabotulinumtoxinA (BoNTA) in the long term and up to 4 years of treatment in chronic migraine (CM). This study aims to assess the safety profile and efficacy of BoNTA in CM after 5 years of treatment in a real-life setting. Methods: We performed a retrospective chart review of patients with CM in relation to BoNTA treatment for more than 5 years in 19 Spanish headache clinics. We excluded patients who discontinued treatment due to lack of efficacy or poor tolerability. Results: 489 patients were included [mean age 49, 82.8% women]. The mean age of onset of migraine was 21.8 years; patients had CM with a mean of 6.4 years (20.8% fulfilled the aura criteria). At baseline, patients reported a mean of 24.7 monthly headache days (MHDs) and 15.7 monthly migraine days (MMDs). In relation to effectiveness, the responder rate was 59.1% and the mean reduction in MMDs was 9.4 days (15.7 to 6.3 days; p < 0.001). The MHDs were also reduced by 14.9 days (24.7 to 9.8 days; p < 0.001). Regarding the side effects, 17.5% experienced neck pain, 17.3% headache, 8.5% eyelid ptosis, 7.5% temporal muscle atrophy and 3.2% trapezius muscle atrophy. Furthermore, after longer-term exposure exceeding 5 years, there were no serious adverse events (AE) or treatment discontinuation because of safety or tolerability issues. Conclusion: Treatment with BoNTA led to sustained reductions in migraine frequency, even after long-term exposure exceeding 5 years, with no evidence of new safety concerns.

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