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Observational Study
. 2024 May 11;16(5):221.
doi: 10.3390/toxins16050221.

Effectiveness and Safety of OnabotulinumtoxinA in Adolescent Patients with Chronic Migraine

Laura Gómez-Dabó  1   2 , Edoardo Caronna  1   2 , Rut Mas-de-Les-Valls  2 , Víctor J Gallardo  2 , Alicia Alpuente  1   2 , Marta Torres-Ferrus  1   2 , Patricia Pozo-Rosich  1   2
Affiliations
Observational Study

Effectiveness and Safety of OnabotulinumtoxinA in Adolescent Patients with Chronic Migraine

Laura Gómez-Dabó et al. Toxins (Basel). .

Abstract

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.

Keywords: adolescents; children; migraine; onabotulinumtoxinA; teenagers.

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Conflict of interest statement

L.G.-D. reports no disclosures. E.C. has received honoraria from Novartis, Chiesi, Lundbeck, MedScape; his salary has been partially funded by Río Hortega grant Acción Estratégica en Salud 2017–2020, Instituto de Salud Carlos III (CM20/00217). He is a junior editor for Cephalalgia. R.M.-d.-l.-V. reports no disclosures. V.J.G. reports no disclosures. A.A. has received honoraria from Allergan-AbbVie, Novartis, Chiesi. M.T.-F. has received honoraria from Allergan-AbbVie, Novartis, Chiesi and Teva. P.P.-R. has received, in the last three years, honoraria as a consultant and speaker for: AbbVie, Biohaven, Chiesi, Eli Lilly, Lundbeck, Medscape, Novartis, Pfizer and Teva. Her research group has received research grants from AbbVie, Novartis and Teva; as well as, Instituto Salud Carlos III, EraNet Neuron, European Regional Development Fund (001-P-001682) under the framework of the FEDER Operative Programme for Catalunya 2014-2020-RIS3CAT; has received funding for clinical trials from AbbVie, Amgen, Biohaven, Eli Lilly, Novartis, Teva. She is the Honorary Secretary of the International Headache Society. She is in the editorial board of Revista de Neurologia. She is an associate editor for Cephalalgia, Headache, Neurologia, The Journal of Headache and Pain and Frontiers of Neurology. She is a member of the Clinical Trials Guidelines Committee of the International Headache Society. She has edited the Guidelines for the Diagnosis and Treatment of Headache of the Spanish Neurological Society. P.P.-R does not own stocks from any pharmaceutical company.

Figures

Figure 1
Figure 1
Median reduction in headache frequencies across the study period (baseline 0–month, 6–month and 12–month follow-up). The median reduction in MHD, MMD and AMDM is represented in days/month. MHD: monthly headache days; MMD: monthly migraine days; AMDM: acute medication days/month.
Figure 2
Figure 2
Flowchart of study selection for review.
See this image and copyright information in PMC

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