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

Background Monoclonal antibodies targeting the CGRP pathway (anti-CGRP mAbs, aCGRP mAbs) have a favorable safety profile and are effective for the preventive treatment of episodic (EM) and chronic migraine (CM) in adults. According to some guidelines for health insurance reimbursement, ineffective use of one aCGRP mAb, 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. This includes also switches from CGRP-receptor antibodies (erenumab) to ligand antibodies (galcanezumab or fremanezumab) and vice versa. The aim of this preliminary analysis is to quantify the effectiveness of switching between aCGRP mAbs due to lack of efficacy of previous aCGRP mAb treatment.

Methods FINESSE is a multicenter, two-country (Germany, Austria) prospective non-interventional study (NIS) in which effectiveness and tolerability of fremanezumab in adults with EM and CM are evaluated in routine clinical practice. Medical history of patients is documented at baseline, including past preventive treatment (PPT) with another aCGRP mAb (erenumab or galcanezumab). This preliminary subgroup analysis (cut-off date 14.05.21) focused on preventive migraine treatments 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 the monthly average number of migraine days (MMD) that was evaluated during the 6-month period after the first dose of fremanezumab.

Results 574 patients with fully documented baseline visit were included (89,4% female, 45,7±12,2 years of age); 58,4% had EM, 41,6% CM. Of those, 308 had completed the 6-month visit, 241 without and 67 with prior exposure to another aCGRP mAb. Four patients had been previously treated with galcanezumab, 2 with galcanezumab and erenumab, and 61 with erenumab only. The main reason for discontinuation of prior aCGRP mAb therapy was, according to the patients at baseline visit, lack of efficacy in 57 patients (85,1%) and other reasons in 10 patients (14,9%). In total 150 patients (48,7% of 308) achieved the primary endpoint of≥50% reduction from baseline in MMD at month 6 after first dose of fremanezumab. In the subgroup of patients with lack of efficacy of prior aCGRP mAbs, 18 of 57 (31,6%) reached the primary endpoint compared to 3 of 10 in patients with other reasons for switching (30,0%), and 129 of 241 in patients without prior aCGRP mAb treatment (53,5%).

Conclusion This preliminary data provides prospective real-world evidence that treatment with fremanezumab is effective in about 30% of patients with prior ineffective aCGRP mAb treatment. For these patients, a switch should not be withheld since it can be a promising treatment option.

Publikationsverlauf

Artikel online veröffentlicht:
05. Mai 2022