Early and clinically meaningful functional improvement following CGRP monoclonal antibodies in adolescents with migraine: A real-world retrospective study
Abstract
BackgroundEvidence supporting calcitonin gene-related peptide monoclonal antibody (CGRP mAb) use in adolescents with migraine is limited. Rapid recovery for daily school functioning is particularly important during this stage of life. We aimed to evaluate early functional outcomes in daily and school activities, as well as headache-related outcomes after initiating CGRP mAb therapy in Japanese adolescents with migraine.MethodsThis single-center retrospective cohort study included patients aged 15-17 years who received CGRP mAb therapy (galcanezumab, fremanezumab or erenumab) for migraine between May 2021 and July 2025. The primary outcome was time to clinically meaningful improvement on the Headache Impact Test-6 (HIT-6) scores, comprising a reduction of ≥ 6 points from baseline, and was analyzed using the Kaplan-Meier method. Secondary outcomes included tracking longitudinal HIT-6 trajectories with mixed-effects models for repeated measures, exploratory univariable comparisons for early response (≥ 6-point reduction within 10-14 weeks), questionnaire-based daily functioning assessments, and safety evaluations.ResultsOf 34 adolescents who initiated CGRP mAb therapy, 33 participated in HIT-6 analyses. The cumulative response rate began increasing immediately after treatment initiation, reaching 68.3% (95% confidence interval = 44.6-81.8%) within the 10-14-week period; approximately half of the responders achieved meaningful improvement by weeks 4-6. Mixed-effects models for…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 34 participants or records.
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