Response to fremanezumab in migraine patients with and without prior aCGRP mAbs - preliminary data from the FINESSE study

Abstract text (incl. figure legends and references)

Objective: According to guidelines for health insurance reimbursement, ineffective use of one aCGRP mAb (monoclonal antibody targeting the CGRP pathway), defined by not reaching a reduction of monthly migraine days (MMD) by 50% compared to baseline after 6 months of treatment, excludes reimbursement of another aCGRP mAb. The aim of this preliminary analysis is to quantify the effectiveness of switching to another aCGRP mAb.

Methods: FINESSE is a multicenter, two-country (Germany, Austria) prospective, non-interventional study in which effectiveness and tolerability of fremanezumab in adults with episodic (EM) or chronic migraine (CM) are evaluated in clinical practice. Medical history is documented at baseline, including past preventive treatment (PPT) with another aCGRP mAb. A subgroup analysis (14.05.21) focused on PPT with other aCGRP mAbs prior to initiation of fremanezumab. Distribution of patients with and without ineffective PPT with another aCGRP mAb was analysed for the primary endpoint of FINESSE, the proportion of patients reaching ≥50% reduction in monthly migraine days (MMD) that was evaluated during the 6-month period after the first dose of fremanezumab.

Results: 308 patients had completed the 6-month visit, 241 without and 67 with prior exposure to another aCGRP mAb. The main reason for discontinuation of prior aCGRP mAb therapy was low efficacy (LoE) in 57 patients (85.1%). In total 150 of 308 patients (48.7%) achieved the primary endpoint of ≥50% reduction in MMD. Eighteen of 57 (31.6%) patients with LoE of prior aCGRP mAbs reached the primary endpoint compared to 129 of 241 (53.5%) patients without prior aCGRP mAb treatment.

Conclusion: This first data provides prospective real-world evidence that treatment with fremanezumab is effective in about 30% of patients with prior LoE under aCGRP mAb treatment. For these patients, a switch should not be withheld.