Effectiveness of Fremanezumab for the Preventive Treatment of Migraine: Second Interim Analysis of the Observational PEARL Study
Messoud Ashina1, Dimos D Mitsikostas2, Faisal M Amin3, Pinar Kokturk4, Gurdal Sahin5, Christoph J Schankin6, Paul J Dorman7, Patricia Pozo-Rosich8, Leonidas Lyras4, Coleen Myers9, Andrew H Ahn9, Cristina Tassorelli10
1Danish Headache Center, University of Copenhagen, Rigshopitalet, 2Aeginition Hospital, National and Kapodistrian University of Athens, 3Danish Headache Center, University of Copenhagen, Rigshopitalet, Department of Neurorehabilitation/Traumatic Brain Injury, Righospitalet, University of Copenhagen, 4Teva Netherlands B.V., 5Department of Clinical Sciences of Lund, Lund University, Skåneuro Neurology Clinic, 6Inselspital, University Hospital Bern, University of Bern, 7The Newcastle upon Tyne Hospitals NHS Foundation Trust, 8Headache Unit & Research Group, Vall d’Hebron Hospital & Research Institute, Universitat Autonoma de Barcelona, 9Teva Branded Pharmaceutical Products R&D, Inc., 10IRCCS Mondino Foundation, University of Pavia, Pavia, Italy
Objective:
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.
Background:
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).
Design/Methods:
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.
Results:
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.
Conclusions:
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.