CONFERENCE UPDATES: AAN 2024

Observational FINESSE study of real-world effectiveness and tolerability of fremanezumab in episodic and chronic migraine

20 Jun 2024

STUDY DESIGN

Fremanezumab is an anti-migraine agent that has been shown to be effective and well-tolerated in patients with episodic migraine (EM) and chronic migraine (CM).1 Real-world data are required to support these clinical findings in real-world populations.1

FINESSE is an ongoing, non-interventional, multi-center, two-country (Germany and Austria), prospective, 24-month, observational study conducted to evaluate the real-world effectiveness and tolerability of fremanezumab in EM and CM prevention.1 The study included a total of 926 patients, with a slightly higher proportion of EM patients (56.5%) compared with those who had CM (43.5%).1 The patients had a mean age of 45.6, and the majority (89.3%) were female.1 This third interim analysis of the FINESSE study evaluated outcomes from adult patients with either EM or CM who were receiving fremanezumab treatment as part of their routine clinical management for up to 1 year.1 The analysis of effectiveness was based on data obtained from patient diaries and patient-reported outcome measures.1

The primary endpoint of the FINESSE study was the proportion of patients who experienced ≥50% reduction in the average number of monthly migraine days (MMDs) over the first 6 months following the initiation of fremanezumab treatment.1 Secondary endpoints included changes in the average number of MMDs, disability scores assessed by Migraine Disability Assessment (MIDAS), 6-Item Headache Impact Test (HIT-6) and other acute migraine medication utilization alongside fremanezumab.1 Safety data were collected based on the documentation of adverse events (AEs) reported during the routine clinical management of patients.1

FINDINGS

Primary endpoint:

  • The primary endpoint of FINESSE was the proportion of patients who experienced ≥50% reduction in the average number of MMDs over the first 6 months following the initiation of fremanezumab treatment1
  • 53.8% of patients (EM: 58.4%; CM: 47.4%) achieved ³50% MMDs reduction 1
  • Two-thirds of CM patients achieved a ³30% reduction in MMDs1

Secondary endpoints:

  • Secondary endpoints included changes in the average number of MMDs, disability scores assessed by MIDAS and HIT-6, and other acute migraine medication utilization alongside fremanezumab1
  • Approximately 60% reduction in mean MMDs from baseline (12.6 MMDs) to month 6 (5.3 MMDs) and month 12 (5.0 MMDs) was observed1
  • Approximately 60% reduction in mean MIDAS score from baseline (75.2) to month 6 (32.0) and month 12 (27.3) was observed1
  • Approximately 10% reduction in mean HIT-6 score from baseline (65.9) to month 6 (57.2) and month 12 (57.0) was observed1
  • Monthly intake of concomitant acute medication was reduced from 9.6 days at baseline to 3.7 days at month 6 and month 121

 

Safety:

  • Tolerance data were in line with its known safety profile1
  • The most frequently reported AEs included injection site reaction (17.3%), coronavirus disease 2019 (COVID-19) (15.8%), drug ineffectiveness (12.1%)1
  • Constipation was a rare AE that was reported in 2.9% of patients1

 

"Sustained reductions in MMD, disability and acute medication use were observed at 6 and 12 months post-fremanezumab initiation"
Dr. Mario Ortega
Teva Pharmaceuticals

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