Long-term safety of OnabotulinumtoxinA treatment in chronic migraine patients: a five-year retrospective study
Por:
Navarro-Pérez, MP, González-Quintanilla, V, Muñoz-Vendrell, A, Madrigal, E, Alpuente, A, Latorre, G, Molina, F, Monzón, MJ, Medrano, V, García-Azorín, D, González-Oria, C, Gago-Veiga, A, Velasco, F, Beltrán, I, Morollón, N, Viguera, J, Casas-Limón, J, Rodriguez-Vico, J, Cuadrado, E, Irimia, P, Iglesias, F, Guerrero-Peral, áL, Belvís, R, Pozo-Rosich, P, Pascual, J, Santos-Lasaosa, S
Publicada:
13 jun 2024
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.
Filiaciones:
Navarro-Pérez, MP:
Hosp Clin Univ Lozano Blesa, Zaragoza, Spain
Inst Hlth Res Aragon, Zaragoza, Spain
Univ Zaragoza, Zaragoza, Spain
González-Quintanilla, V:
Univ Cantabria, Hosp Univ Marques Valdecilla, Santander, Spain
IDIVAL, Santander, Spain
Muñoz-Vendrell, A:
Hosp Bellvitge Princeps Espanya, Barcelona, Spain
Madrigal, E:
Hosp Univ Burgos, Burgos, Spain
Alpuente, A:
Vall dHebron Univ Hosp, Neurol Dept, Headache Clin, Barcelona, Spain
Vall dHebron Res Inst, Headache & Neurol Pain Res Grp, Barcelona, Spain
Latorre, G:
Univ Rey Juan Carlos, Hosp Univ Fuenlabrada, Madrid, Spain
Molina, F:
Hosp Univ Son Espases, Palma De Mallorca, Spain
Monzón, MJ:
Hosp Clin Univ Miguel Servet, Zaragoza, Spain
Medrano, V:
Hosp Gen Univ Elda, Alicante, Spain
García-Azorín, D:
Hosp Clin Univ Valladolid, Valladolid, Spain
González-Oria, C:
Hosp Clin Univ Virgen Rocio, Seville, Spain
Gago-Veiga, A:
Hosp Univ La Princesa, Madrid, Spain
Velasco, F:
Hosp Univ Cruces, Bilbao, Spain
Beltrán, I:
Hosp Gen Univ Alicante, Alicante, Spain
Morollón, N:
Hosp Santa Creu I St Pau, Dept Neurol, Headache & Neuralgia Unit, Barcelona, Spain
Viguera, J:
Hosp Univ Virgen Macarena, Unidad Clin gest Neurociencias, Seville, Spain
Casas-Limón, J:
Hosp Univ Fdn Alcorcon, Madrid, Spain
Rodriguez-Vico, J:
Hosp Univ Fdn Jimenez Diaz, Madrid, Spain
Cuadrado, E:
Hosp Mar, Barcelona, Spain
Irimia, P:
Clin Univ Navarra, Neurol Dept, Pamplona, Spain
Iglesias, F:
Hosp Univ Burgos, Burgos, Spain
Guerrero-Peral, áL:
Hosp Clin Univ Valladolid, Valladolid, Spain
Belvís, R:
Hosp Santa Creu I St Pau, Dept Neurol, Headache & Neuralgia Unit, Barcelona, Spain
Pozo-Rosich, P:
Vall dHebron Univ Hosp, Neurol Dept, Headache Clin, Barcelona, Spain
Vall dHebron Res Inst, Headache & Neurol Pain Res Grp, Barcelona, Spain
Pascual, J:
Univ Cantabria, Hosp Univ Marques Valdecilla, Santander, Spain
IDIVAL, Santander, Spain
Santos-Lasaosa, S:
Hosp Clin Univ Lozano Blesa, Zaragoza, Spain
Inst Hlth Res Aragon, Zaragoza, Spain
Univ Zaragoza, Zaragoza, Spain
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