Fremanezumab for Migraine Prevention: Interim Analysis of the Non-Interventional FINESSE Study
Andreas Straube1, Gregor Brössner2, Charly Gaul3, Xenia Hamann4, Torsten Kraya5, Isabel Schauerte6, Lars Neeb7
1Ludwig-Maximilians-University Munich, 2Medical University of Innsbruck, 3Headache Center Frankfurt, 4Teva GmbH, 5St. Georg Hospital/ Headache Center Halle, 6Institut Dr. Schauerte, 7Charité Universitätsmedizin Berlin, Department of Neurology, Berlin, Germany, Helios Global Health, Berlin, Germany
Objective:
To evaluate effectiveness and tolerability of fremanezumab in routine clinical practice.
Background:
Fremanezumab, a humanized monoclonal antibody that selectively targets calcitonin gene‑repeated peptide, is authorized for the preventive treatment of episodic and chronic migraine (EM, CM) in adults with ≥4 migraine days/month. Here we present interim data from the non‑interventional FINESSE study.
Design/Methods:
FINESSE is a multicenter, prospective, observational study in patients with EM or CM, with follow‑up at 24 months. Primary endpoint: proportion of patients reaching ≥50% reduction in the average number of monthly migraine days (MMD) over 6 months, post-initial dose. Secondary endpoints: changes in monthly average number of MMDs, disability scores (Migraine Disability Assessment Questionnaire [MIDAS], Six-Item Headache Impact Test [HIT-6]), use of concomitant acute migraine medication.
Results:
883 adult patients (88.2% female; EM: 55.9%, CM: 44.1%) were evaluated. 323/588 patients (54.9%; intention-to-treat analysis) achieved a MMD reduction of ≥50% over 6 months (EM; 60.6% versus CM; 47.4%). Average number of MMDs decreased (12.6±6.0 [baseline]; 5.2±5.6 [6 months] and remained constant up to month 12 (5.2±5.0). Mean MIDAS scores decreased (72.7±64.1 [baseline]; 29.8±39.9 [6 months]; 22.3±28.0 [12 months]), as did Mean HIT-6 scores (65.7±4.7 [baseline]; 56.9±8.4 [6 months]; 56.4±8.5 [12 months]). Acute migraine medication use also decreased (9.6±5.0 days/month [baseline]; 3.7±4.1 days/month [month 6]; 3.9±3.8 days/month [month 12]).
Conclusions:
54.9% of patients achieved the primary endpoint. Mean number of MMDs, MIDAS, HIT-6 scores, and use of acute migraine medication decreased from baseline to month 6. Effectiveness was maintained at month 12 (versus month 6), though data were only available for a subset of considered patients at the time point of analysis. A 24-month observational period is planned.
Material from: Straube A, et al. Schmerz 2022, Springer Medizin (Suppl 1):S34. https://doi.org/10.1007/s00482-022-00667-5 reproduced with permission of SNCSC