Abstract text (incl. figure legends and references)

Objective: Fremanezumab, a humanised monoclonal antibody, that selectively targets calcitonin gene-related peptide (CGRP), is approved in Europe for migraine prevention in adults with ≥4 monthly migraine days (MMD). PEARL study aims to provide real-world data on effectiveness, acute medication use, and disability in patients (pts) initiating fremanezumab treatment. Here we present the second interim analysis.

Methods: PEARL is a 24-month, pan-European, prospective, observational study. Eligible pts are adults (≥18 years) diagnosed with episodic or chronic migraine (EM, CM) and starting fremanezumab treatment. The primary endpoint is the proportion of pts with ≥50% reduction from baseline (BL) in average MMD (≥50% response) during the 6 months post fremanezumab initiation. Secondary endpoints were assessed at multiple timepoints from Months 1 to 24 and include mean change from BL in: MMD; average monthly days of acute migraine medication use; disability scores (Migraine Disability Assessment [MIDAS] and 6-item Headache Impact Test [HIT-6]).

Results: 574 pts (EM, 26%; CM, 74%) were evaluated in this interim analysis; 65% had used prior anticonvulsants, 61% beta-blockers, and 51% tricyclic antidepressants for preventive treatment. For patients with data for the primary endpoint (n = 313), 56% (EM, 69%; CM, 52%) achieved ≥50% MMD response during the 6 months after fremanezumab initiation. For secondary endpoints, the mean±SD change from BL at Month 6 was –8.0±7.1 for MMD, –6.7±6.2 for average monthly days of acute migraine medication use, –52.7±58.5 for MIDAS score, –9.5±8.8 for HIT-6 score. One pt experienced a drug-related serious adverse event of dysphonia.

Conclusion: The real-world effectiveness of fremanezumab is supported by this interim analysis, with more than half of pts reporting a ≥50% reduction in MMD during the 6 months after fremanezumab initiation, improvement in other secondary outcome measures, and favorable safety profile.