Real-world effectiveness and safety of CGRP monoclonal antibodies in elderly migraine patients: a Korean multicenter study.

backgroundWhile calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) have demonstrated significant efficacy in general migraine populations, real-world data specifically focusing on elderly patients remain limited. This multicenter study aimed to evaluate the long-term effectiveness and safety of CGRP mAbs in Korean migraine patients aged 65 and older.

methodsThis multicenter, retrospective real-world study analyzed 107 patients aged ≥ 65 years initiated on CGRP mAbs (galcanezumab or fremanezumab) at nine Korean university hospitals between January 2022 and April 2025. Effectiveness was measured by the proportion of patients achieving a ≥ 30%, ≥ 50%, or ≥ 75% reduction in monthly headache days (MHD) at 3, 6, and 12 months. Response rates were reported using an intention-to-treat (ITT) framework in which non-attendees were conservatively classified as non-responders, with the observed-case analysis presented as a sensitivity analysis. Safety was ascertained at each follow-up visit through open-ended clinical interview and patient self-report; adverse events were adjudicated for drug relationship by the treating clinician. Multivariable logistic regression identified independent predictors of ≥ 50% response at 3 months.

resultsOf 107 enrolled patients, 103 reached the 3-month time point, 93 reached 6 months, and 61 reached 12 months by the data lock. On an ITT basis, the ≥ 50% response rate was 38.8% (40/103) at 3 months, 40.9% (38/93) at 6 months, and 31.1% (19/61) at 12 months. The corresponding observed-case rates were 48.2%, 67.9%, and 70.4%, respectively. A linear mixed-effects model confirmed a significant reduction in MHD over time (F = 48.912, p < 0.001). Female sex was a significant positive predictor of ≥ 50% response at 3 months (adjusted OR 3.21, 95% CI 1.04-9.93, p = 0.043), while prior failure of OnabotulinumtoxinA was a negative predictor (adjusted OR 0.18, 95% CI 0.03-0.95, p = 0.043). One all-cause death (ruptured dissecting aneurysm) occurred during follow-up and was adjudicated as unrelated to study drug; no other serious adverse events were reported. Documented adverse events were mild and included constipation and injection site reactions.

conclusionAlthough long-term follow-up data were available for only a limited number of patients, a substantial proportion of those who continued treatment demonstrated a response of at least 50%. These results imply that CGRP-targeted therapy could be an effective and well-tolerated preventive treatment option for older migraine patients.