To evaluate effectiveness and side effects of fremanezumab as preventive treatment of episodic migraine (EM) and chronic migraine (CM) during 6 months after first dose in a real-world setting.

Fremanezumab is a monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP). It has been found to be safe and effective for the preventive treatment of EM and CM in adults with ≥4 migraine days/month. The non-interventional FINESSE study aims to provide real-world evidence of fremanezumab treatment outcomes by evaluating effectiveness in routine clinical practice.

Prospective, non-interventional study in adults with EM or CM in routine clinical practice. Primary endpoint: proportion of patients reaching ≥ 50% reduction in average MDM (Migraine Days per Month) during 6 months after first dose. Relevant secondary endpoints include changes from baseline in: monthly average number of migraine days, disability scores (Migraine Disability Assessment questionnaire [MIDAS]; six-item Headache Impact Test [HIT-6]) and days of concomitant acute migraine medication.

567 patients were included (88.0% female, 45.8 ± 12.4 years of age); 54.7% had EM, 41.6% CM. 216 had completed the 6-month visit. At month 6, 49.1% of patients achieved the primary endpoint (≥ 50% MDM reduction over 6 months); more patients with EM (54.0%) than with CM (42.4%) achieved the primary endpoint. The MIDAS disability score improved for 38.7% of patients at month 6, and the HIT-6 score also improved for 36.3% of patients at month 6.

Approximately half of all patients achieved ≥ 50% MDM reduction over 6 months. More than a third of all patients reported improved MIDAS and HIT-6 scores. The study is still recruiting and a later interim analysis will reveal further information.