Objective:

To evaluate effectiveness and tolerability of fremanezumab administered in migraine patients, who switched from a previous anti-calcitonin gene-related peptide (CGRP) pathway monoclonal antibody (mAb), as part of their routine disease management.

Background:

Fremanezumab is a humanized mAb that selectively targets the CGRP ligand and is authorized for preventive treatment of episodic (EM) and chronic migraine (CM) in adults. 

Design/Methods:

FINESSE is an ongoing prospective, non-interventional study in adults with EM or CM. The observation period is 24 months. The primary endpoint is the proportion of patients reaching ≥50% reduction in average number of monthly migraine days (MMD) during the 6-month period after the first dose of fremanezumab. Further measures include monthly average number of migraine days, MIDAS (Migraine Disability Assessment), HIT-6 (6-Item Headache Impact Test), and acute medication use. In this subgroup analysis, 6-month-data in patients who experienced poor effectiveness or tolerability with a prior anti-CGRP pathway mAb and therefore switched to fremanezumab are presented.

Results:

Of 140 patients (47.6 ± 11.5 years, 84.7% female), 54 (38.6%) achieved a MMD reduction of ≥ 50% over 6 months (EM: 44.3%, CM: 31.2%). Number of MMD decreased from 13.3 ± 6.42 at baseline, by 6.1 ± 5.47 (month 6). Acute migraine medication was used on 9.5 ± 4.92 days/month at baseline and decreased to 5.0 ± 3.86 days/month (month 6). MIDAS score decreased from 71.1 ± 57.1 (baseline, N=68), to 43.7 ± 44.4 (month 6, N=48). HIT-6 score decreased from 65.8 ± 4.8 (baseline, N=78), to 59.6 ± 7.9 (month 6, N=55).

Conclusions:

In this interim analysis of the FINESSE non-interventional study, 38.6% of anti-CGRP pathway mAb-non-responders benefit (≥50% response) from switching to fremanezumab. These results suggest that switching to fremanezumab may be a promising option for patients experiencing inadequate efficacy or poor tolerability with prior other anti-CGRP pathway mAb use.