Effectiveness, tolerability and response predictors of preventive anti-CGRP mAbs for migraine in patients over 65 years old: a multicenter real-world case-control study.

To evaluate clinical characteristics, effectiveness, and tolerability of preventive anti-CGRP mAbs in the elderly. Anti-CGRP mAbs have demonstrated efficacy and safety in patients with migraine although there is limited information regarding the elderly. We performed a multicenter case-control study of cases(patients over 65 years old) and controls(sex-matched patients under 55 years old) with migraine receiving anti-CGRP mAbs. We included the demographic characteristics, effectiveness-reduction in the number of monthly headache days(MHD) and monthly migraine days(MMD),30%,50% and 75% responder rates- and treatment emergent adverse events(TEAEs);the primary endpoint was the 50% response rate regarding MHD at weeks 20-24; exploratory 50% response predictors in the elderly were evaluated. 228 patients were included-114 cases,114 controls-. Among cases 84.2%(96/114) were women,79.8%(91/114)CM;mean age of cases 70.1 years old(range:66-86);mean age of controls was 42.9 years old(range:38-49). Cases had a higher percentage of vascular risk factors(p < 0.05),older age of onset(p < 0.001) and more reported prior preventive treatments(p < 0.001). Regarding effectiveness, in cases, 50% response rate was achieved by 59.2%(90/152) at 20-24 weeks, with lower reduction in the MHD at 8-12 weeks [5(7.2),8(9.1);p=0.001] and a higher reduction in MMD at 20-24 weeks [10.7(9.1), 9.2(7.7);p=0.04] compared to the control group. The percentage of a TEAEs was similar in the two groups. Diagnosis of EM(p = 0.003) and lower number of MHD at baseline(p < 0.001) were associated with a 50% response in the elderly in univariate analysis. Our study provides real world evidence of effectiveness and safety of anti-CGRP mAbs for migraine in patients without upper age-limit and possible predictors of anti-CGRP response in the elderly.

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