Long-term safety of OnabotulinumtoxinA treatment in chronic migraine patients: a five-year retrospective study

Navarro-Pérez, María Pilar ; González-Quintanilla, Vicente ; Muñoz-Vendrell, Albert ; Madrigal, Elisabet ; Alpuente, Alicia ; Latorre, Germán ; Molina, Francis ; Monzón, María José ; Medrano, Vicente ; García-Azorín, David ; González-Oria, Carmen ; Gago-Veiga, Ana ; Velasco, Fernando ; Beltrán, Isabel ; Morollón, Noemí ; Viguera, Javier ; Casas-Limón, Javier ; Rodríguez-Vico, Jaime ; Cuadrado, Elisa ; Irimia, Pablo ; Iglesias, Fernando ; Guerrero-Peral, Ángel Luis ; Belvís, Robert ; Pozo-Rosich, Patricia ; Pascual, Julio ; Santos-Lasaosa, Sonia (Universidad de Zaragoza)
Long-term safety of OnabotulinumtoxinA treatment in chronic migraine patients: a five-year retrospective study
Resumen: 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.

Idioma: Inglés
DOI: 10.3389/fneur.2024.1417831
Año: 2024
Publicado en: Frontiers in Neurology 15 (2024), [7 pp.]
ISSN: 1664-2295

Tipo y forma: Article (Published version)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
Exportado de SIDERAL (2024-07-19-18:29:06)


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