Scientific publications

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

Jun 13, 2024 | Magazine: Frontiers in Neurology

María Pilar Navarro-Pérez  1   2 , Vicente González-Quintanilla  3 , Albert Muñoz-Vendrell  4 , Elisabet Madrigal  5 , Alicia Alpuente  6   7 , Germán Latorre  8 , Francis Molina  9 , María José Monzón  10 , Vicente Medrano  11 , David García-Azorín  12 , Carmen González-Oria  13 , Ana Gago-Veiga  14 , Fernando Velasco  15 , Isabel Beltrán  16 , Noemí Morollón  17 , Javier Viguera  18 , Javier Casas-Limón  19 , Jaime Rodríguez-Vico  20 , Elisa Cuadrado  21 , Pablo Irimia  22 , Fernando Iglesias  5 , Ángel Luis Guerrero-Peral  12 , Robert Belvís  17 , Patricia Pozo-Rosich  6   7 , Julio Pascual  3 , Sonia Santos-Lasaosa  1   2


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.

CITATION  Front Neurol. 2024 Jun 13:15:1417831.  doi: 10.3389/fneur.2024.1417831

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