Abstract Details

Title Fremanezumab Effectiveness and Tolerability in Clinical Routine: Interim Real-world Data of the Observational FINESSE Study

Topic Headache

Presentation(s) P4 - Poster Session 4 (11:45 AM-12:45 PM)

Poster/Presentation
Number 12-002

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.

Authors/Disclosures
Mario Ortega, PhD (Teva Pharmaceuticals) PRESENTER	Dr. Ortega has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Andreas Straube	Andreas Straube has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TEVA. Andreas Straube has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. Andreas Straube has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Novartis.
Gregor Broessner	Gregor Broessner has received personal compensation in the range of $0-$499 for serving as a Consultant for Novartis. Gregor Broessner has received personal compensation in the range of $0-$499 for serving as a Consultant for TEVA. Gregor Broessner has received personal compensation in the range of $0-$499 for serving as a Consultant for Lilly. Gregor Broessner has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for TEVA. Gregor Broessner has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. Gregor Broessner has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lilly.
Xenia Hamann (Teva GmbH)	Xenia Hamann has received personal compensation for serving as an employee of Teva GmbH.
Charly Gaul (Headache Center Frankfurt, Frankfurt am Main, Germany)	The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TEVA. The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. The institution of an immediate family member of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Vectura. The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. The institution of Charly Gaul has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merz. The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Dr. Reddy. Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Perfood. Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Reckitt-Benckiser . The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Hormosan. The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Chordate. The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Dr. Reddy. The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie.
Torsten Kraya, MD (Klinikum St. Georg Leipzig, Klinik für Neurologie)	Dr. Kraya has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TEVA, Novartis, Lilly. Dr. Kraya has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA, Novartis, Lilly, Hormosan, Abbvie.
Lars Oliver Neeb (Helios Global Health GmbH)	No disclosure on file

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