PEARL study protocol: a real-world study of fremanezumab effectiveness in patients with chronic or episodic migraine
This clinical trial protocol, which has been recently published in our partner journal Pain Management, describes the design and rationale of the Pan-European Real Life (PEARL) study. PEARL is an ongoing, 24-month, multicenter, pan-European, prospective, observational, Phase IIII study investigating fremanezumab effectiveness in patients with chronic migraine (CM) or episodic migraine (EM). It is registered with the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (EUPAS35111). The study is being conducted at approximately 100 sites, including a mix of specialized headache centers and general hospitals, across 11 European countries (the Czech Republic, Denmark, Finland, Greece, Italy, Norway, Portugal, Spain, Sweden, Switzerland and the UK).
The objectives of the study are to evaluate the effectiveness of fremanezumab treatment and other measures of clinical treatment, including concomitant preventive and acute migraine medication use and treatment adherence and persistence, in adult patients with CM or EM in European real-world clinical practice. The results of the PEARL study will fill gaps in the understanding of the real-world effectiveness of fremanezumab and in treatment patterns and effectiveness after switching from another CGRP pathway–targeting treatment. Also, this study will provide real-world evidence for optimizing and standardizing prescription procedures across countries.
Abstract
Fremanezumab is a humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP) approved in Europe for migraine prevention in adults with ≥4 migraine days/month. The Pan-European Real Life (PEARL) study is a 24-month, prospective, observational study of fremanezumab in CM or EM. Endpoints include proportion of patients with ≥50% reduction in monthly migraine days (MMDs) during 6 months of treatment (primary); changes in MMDs, disability scores and acute headache medication use; adherence and persistence; and effectiveness in patients switching from another CGRP pathway–targeting monoclonal antibody. PEARL is being conducted in approximately 100 centers in 11 European countries (estimated N=1100). PEARL will generate important real-world data on effectiveness of fremanezumab and treatment patterns in patients with CM or EM.
Lay abstract
Fremanezumab is an injectable biologic medication that targets CGRP, a substance released in the nerves and blood vessels during a migraine attack that plays a role in migraine pain. Fremanezumab is approved in Europe for preventing migraine in adults who experience ≥4 migraine days per month. The PEARL study is a 24-month long study that will observe patients with migraine who are starting treatment with fremanezumab in a clinical practice setting under the care of their treating physician. The major goals of the study are to evaluate the effectiveness of fremanezumab for reducing days with migraine attacks in a month, disability associated with migraine, and use of acute headache medications to treat migraine, including in patients switching from other biologic migraine therapies in the same drug class. The extent to which patients follow their recommended treatment schedule per their providers’ instructions and whether patients discontinue treatment will also be evaluated. The PEARL study will include more than 1000 patients in 100 centers across 11 European countries. The study will provide important information on effectiveness for patients with migraine receiving fremanezumab in the normal course of their treatment, as well as on patients’ use of fremanezumab according to their prescribing physicians’ recommendations.