Long-term effectiveness of fremanezumab in episodic and chronic migraine patients in clinical routine – 24-months results from the prospective non-interventional FINESSE study
Abstract
The CGRP pathway targeting antibody fremanezumab is indicated for prevention of migraine in adults with ≥4 migraine days/month. To address the limited availability in real-world long-term data, the FINESSE study was initiated to provide real-world evidence of long-term effectiveness of fremanezumab in clinical practice in an unselected migraine patient cohort. FINESSE was a non-interventional, prospective, multicentre, two-country (Germany, Austria) study observing migraine patients receiving fremanezumab over 24 months in clinical routine. The primary endpoint was the proportion of patients reaching ≥50% reduction in the monthly average number of migraine days (MMD) during the 6-month period following fremanezumab initiation. Secondary endpoints included changes from baseline in MMD, MIDAS and HIT-6 scores, and use of concomitant acute migraine medication. Exploratory endpoints comprised assessment of number and classes of concomitant preventive and acute migraine medications, and reduction in migraine severity. All secondary and exploratory outcomes were evaluated at multiple timepoints over the 24-month observation period. Safety data were obtained based on documentation of adverse events reported in normal clinical practice. Data analysis was performed using descriptive and, for comparisons to baseline, inferential statistics. Data of 1016 patients (88.7% female; mean age 45.7 (SD 12.4); 55% episodic migraine; 45% chronic migraine) were evaluable in the full analysis…
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: 1,016 participants or records.
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