Real-world effectiveness of fremanezumab in patients with migraine switching from another mAb targeting the CGRP pathway: a subgroup analysis of the Finesse Study

• Published in: Journal of headache and pain Vol. 24; no. 1; pp. 59 - 11
• Main Authors: Straube, Andreas, Broessner, Gregor, Gaul, Charly, Hamann, Xenia, Hipp, Joachim, Kraya, Torsten, Neeb, Lars
• Format: Journal Article
• Language: English
• Published: Milan Springer Milan 23.05.2023; Springer Nature B.V; BMC
• Subjects: Antibodies, Monoclonal; Calcitonin gene-related peptide; Fremanezumab; Headache; Humans; Internal Medicine; Medicine; Medicine & Public Health; Migraine; Migraine Disorders; Monoclonal antibodies; Neurology; Non-responder; Pain Medicine; Patients; Pharmacovigilance; Prospective Studies; Calcitonin gene-related peptide; Fremanezumab; Non-responder; Migraine
• ISSN: 1129-2377; 1129-2369; 1129-2377
• DOI: 10.1186/s10194-023-01593-2

Background Monoclonal antibodies targeting the CGRP pathway are effective and safe for prophylactic treatment of episodic (EM) and chronic migraine (CM). In case of treatment failure of a CGRP pathway targeting mAb, physician has to decide whether using another anti-CGRP pathway mAb is useful. This interim analysis of Finesse Study evaluates effectiveness of the anti-CGRP mAb fremanezumab in patients with a history of other prior anti-CGRP pathway mAb treatments (switch patients). Methods Finesse , a non-interventional, prospective, multicentre, two-country (Germany-Austria) study observing migraine patients receiving fremanezumab in clinical routine. This subgroup analysis presents data on documented effectiveness over 3 months after the first dose of fremanezumab in switch patients. Effectiveness was evaluated based on reduction in average number of migraine days per month (MMDs), MIDAS and HIT-6 scores changes as well as in number of monthly days with acute migraine medication use. Results One hundred fifty-three out of 867 patients with a history of anti-CGRP pathway mAb treatment prior to initiation of fremanezumab were analysed. Switch to fremanezumab led to ≥ 50% MMD reduction in 42.8% of migraine patients, with higher response rate in EM (48.0%) than in CM patients (36.5%). A ≥ 30% MMD reduction was achieved by 58.7% in CM patients. After three months, monthly number of migraine days decreased by 6.4 ± 5.87 (baseline: 13.6 ± 6.5; p  < 0.0001) in all patients, 5.2 ± 4.04 in EM and 7.7 ± 7.45 in CM patients. MIDAS scores decreased from 73.3 ± 56.8 (baseline) to 50.3 ± 52.9 (after 3 months; p  = 0.0014), HIT-6 scores decreased from 65.9 ± 5.0 to 60.9 ± 7.2 ( p  < 0.0001). Concomitant use of acute migraine medication had decreased from 9.7 ± 4.98 (baseline) to 4.9 ± 3.66 (3 months) ( p  < 0.0001). Conclusions Our results show that about 42.8% of anti-CGRP pathway mAb-non-responder benefit from switching to fremanezumab. These results suggest that switching to fremanezumab may be a promising option for patients experiencing poor tolerability or inadequate efficacy with prior other anti-CGRP pathway mAb use. Trial registration Finesse  Study is registered on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (EUPAS44606). Graphical Abstract