Effectiveness and Safety of OnabotulinumtoxinA in Adolescent Patients with Chronic Migraine.

Laura Gómez-Dabó, Edoardo Caronna, Rut Mas-de-Les-Valls, Víctor J Gallardo, Alicia Alpuente, Marta Torres-Ferrus, Patricia Pozo-Rosich

Toxins 2024 May 11

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Chronic migraine (CM) significantly affects underage individuals. The study objectives are (1) to analyze the effectiveness and safety of onabotulinumtoxinA (BTX-A) in adolescents with CM; (2) to review the literature on BTX-A use in the pediatric population. This prospective observational study included patients under 18 years old with CM treated with BTX-A (PREEMPT protocol) as compassionate use. Demographic, efficacy (monthly headache days-MHD; monthly migraine days-MMD; acute medication days/month-AMDM) and side effect data were collected. A ≥ 50% reduction in MHD was considered as a response. Effectiveness and safety were analyzed at 6 and 12 months. A systematic review of the use of BTX-A in children/adolescents was conducted in July 2023. In total, 20 patients were included (median age 15 years [14.75-17], 70% (14/20) females). The median basal frequencies were 28.8 [20-28] MHD, 18 [10-28] MMD and 10 [7.5-21.2] AMDM. Compared with baseline, at 6 months (n = 20), 11 patients (55%) were responders, with a median reduction in MHD of -20 days/month (p = 0.001). At 12 months (n = 14), eight patients (57.1%) were responders, with a median reduction in MHD of -17.5 days/month (p = 0.002). No adverse effects were reported. The literature search showed similar results. Our data supports the concept that BTX-A is effective, well tolerated, and safe in adolescents with CM resistant to oral preventatives.

Citation

Laura Gómez-Dabó, Edoardo Caronna, Rut Mas-de-Les-Valls, Víctor J Gallardo, Alicia Alpuente, Marta Torres-Ferrus, Patricia Pozo-Rosich. Effectiveness and Safety of OnabotulinumtoxinA in Adolescent Patients with Chronic Migraine. Toxins. 2024 May 11;16(5)