This second interim analysis of the ongoing PEARL study aims to provide real-world data on effectiveness, acute medication use, and disability in patients starting fremanezumab treatment.

Fremanezumab, a humanized monoclonal antibody selectively targeting calcitonin gene-related peptide, is approved in Europe for migraine prevention in adults with ≥4 monthly migraine days (MMD).

PEARL is a 24-month, pan-European, prospective, observational study in adults diagnosed with episodic or chronic migraine (EM, CM), initiating fremanezumab. Primary endpoint: proportion of patients with ≥50% reduction from baseline in average MMD (≥50% response) during the 6 months post-fremanezumab initiation. Secondary endpoints include mean change from baseline in: MMD, average monthly days of acute migraine medication use, and disability scores (Migraine Disability Assessment [MIDAS]; 6-item Headache Impact Test [HIT-6]) at different timepoints from Months 1–24.

574 patients (EM, 26%; CM, 74%) were included in the interim full analysis set; 65% had used prior anticonvulsants, 61% beta-blockers, 51% tricyclic antidepressants, 23% angiotensin II receptor antagonists 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 following fremanezumab initiation. For secondary endpoints, the mean±SD change from baseline at Month 6 for MMD was –8.0±7.1, for average monthly days of acute migraine medication use was –6.7±6.2, for MIDAS was –52.7±58.5, and for HIT-6 was –9.5±8.8. Of 897 patients in the safety analysis set, only 1 experienced a drug-related serious adverse event of dysphonia.

This interim analysis supports the real-world effectiveness of fremanezumab, with more than half of patients reporting a ≥50% reduction in MMD during the 6 months after first fremanezumab dose, and improvements in other secondary outcome measures along with a favorable side effect profile.

Previously submitted as: Ashina M, et al. Cephalalgia 2022;42(1_suppl):93-94. doi: 10.1177/03331024221117728.