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Title: | Long-term safety of OnabotulinumtoxinA treatment in chronic migraine patients: a five-year retrospective study |
Author: | 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 |
Issue Date: | 13-Jun-2024 |
Publisher: | Frontiers Media SA |
Abstract: | 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. |
Note: | Reproducció del document publicat a: https://doi.org/10.3389/fneur.2024.1417831 |
It is part of: | Frontiers in Neurology, 2024, vol. 15 |
URI: | http://hdl.handle.net/2445/214947 |
Related resource: | https://doi.org/10.3389/fneur.2024.1417831 |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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fneur-15-1417831.pdf | 288.5 kB | Adobe PDF | View/Open |
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