ArticleBrain and behavior2026
ESTELA-Study: Long-Term Effectiveness and Safety of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies in Real-World Clinical Practice.
Article in Brain and behavior, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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29 authors.
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Abstract
backgroundAnti-CGRP antibodies are effective and safe in real-world migraine management, but guidelines recommend discontinuation after 12-18 months due to limited long-term data and remaining uncertainties regarding optimal treatment duration and sustained safety, highlighting the need for large-scale long-term real-world evidence. This study evaluated their safety and effectiveness in patients treated for ≥2 years.
methodsThis multicenter retrospective study included patients from 13 headache units who received the same anti-CGRP antibody for ≥24 months, excluding discontinuation periods. Baseline characteristics, monthly headache days (MHD), monthly migraine days (MMD), and adverse events (AEs) were recorded at baseline, 6 months, 1, 2, 3, and 4 years. Descriptive statistics were used to summarize clinical characteristics, and appropriate parametric or non-parametric tests were applied for group comparisons. Multivariate analyses were performed to explore associations between baseline variables and long-term treatment response.
resultsA total of 454 patients (91% female, mean age 48) were analyzed, with follow-up at 2 years (n = 454), 3 years (n = 135), and 4 years (n = 17). Treatments included erenumab (39%), galcanezumab (34%), and fremanezumab (27%). Fifty-seven percent maintained continuous therapy, while 43% restarted after discontinuation. Sustained reductions in MHD and MMD were observed at 2, 3, and 4 years (MHD from 20 to 6, 6, 5/MMD from 14 to 4, 4, and 2). Medication overuse decreased from 78% to 13%, 20%, and 18%. Loss of effectiveness occurred in 4.2% after 2 years. AEs appeared in <20%, mostly mild (>80%), leading to discontinuation in 0.4%. Multivariate analysis showed that shorter disease duration prior to anti-CGRP initiation, earlier anti-CGRP initiation, and greater MHD/MMD reduction at 6 months were associated with better long-term outcomes.
conclusionsAnti-CGRP mAbs demonstrate sustained long-term safety and effectiveness, with consistent reduction in headache and migraine days and lower medication overuse. Early initiation and greater initial improvement predict better long-term outcomes. Findings support extending therapy beyond 12-18 months, supporting optimization of clinical protocols.
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