Fremanezumab Effectiveness and Tolerability in Clinical Routine: Interim Real-world Data of the Observational FINESSE Study
Andreas Straube1, Gregor Brössner2, Xenia Hamann3, Charly Gaul4, Torsten Kraya5, Lars Neeb6
1Department of Neurology, University Hospital LMU Munich, 2Department of Neurology, Innsbruck Medical University, 3Teva GmbH, 4Headache Center Frankfurt, 5Department of Neurology, Hospital Sankt Georg Leipzig gGmbH, 6Helios Global Health
Objective:
FINESSE aims to evaluate real-world effectiveness and tolerability of fremanezumab in adults with episodic (EM) or chronic migraine (CM).
Background:
Real-world data on fremanezumab for migraine prevention are needed to complement clinical trial findings.
Design/Methods:
FINESSE is an ongoing multicenter, prospective, observational study in adults with EM or CM. Interim results are reported here (cut-off 31-Jan-2023). Observation period: 24 months. Primary endpoint: proportion of patients reaching ≥50% reduction in average number of monthly migraine days (MMD) during 6 months of fremanezumab treatment. Key outcomes measures: average number of MMD, disability scores (Migraine Disability Assessment [MIDAS], Six-Item Headache Impact Test [HIT-6]), and acute migraine medication use. Adverse events (AEs) documented in routine clinical practice are reported. Values are mean ± SD unless otherwise stated.
Results:
The full analysis set included 926 patients (89.3% female; 45.6±12.4 years of age; EM: 56.5%, CM: 43.5%). Of the intention-to-treat population (N=826), 53.8% achieved the primary endpoint (EM: 58.4%, CM: 47.4%). MMD decreased from 12.6±6.0 (baseline, n=926) to 5.3±5.5 (month 6; n=712), and 5.0±4.8 (month 12; n=484). MIDAS scores decreased from 75.2±63.9 (baseline; n=545) to 32.0±42.3 (month 6; n=500) and 27.3±37.2 (month 12; n=296). HIT-6 scores decreased from 65.9±4.7 (baseline; n=581) to 57.2±8.4 (month 6; n=510) and 57.0±8.5 (month 12; m=303). Acute medication use decreased from 9.6±5.1 days/month (baseline; n=901) to 3.7±4.0 days/month (month 6; n=712) and 3.7±3.6 days/month (month 12; n=484). AEs were reported in 48.6% of the safety analysis set (N=1076). The most common AEs were injection site reactions (186; 17.3%), COVID-19 (170; 15.8%), drug ineffective (130; 12.1%) and constipation (31; 2.9%).
Conclusions:
In this interim analysis of FINESSE, 53.8% of patients achieved the primary endpoint, and reductions in MMD, disability scores and acute medication use were observed at 6 and 12 months of treatment. Tolerability data were consistent with known safety profile.