https://orcid.org/0000-0003-0951-5804
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Abstract
Fremanezumab is a humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide and is 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 chronic or episodic migraine. End points include proportion of patients with ≥50% reduction in monthly migraine days during 6 months of treatment (primary); changes in monthly migraine days, disability scores and acute headache medication use; adherence and persistence; and effectiveness in patients switching from another calcitonin gene-related peptide 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 chronic migraine or episodic migraine.
Lay abstract
Fremanezumab is an injectable biologic medication that targets calcitonin gene-related peptide, 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/month. The Pan-European Real Life (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 >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.
Trial registration number: EUPAS35111 (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance)
Infographic
Infographic: A PDF version of this infographic is available as supplemental material.
Author contributions
All authors provided input into the design of the study, participated in the critical review of this manuscript and approved the final draft for submission.
Financial & competing interests disclosure
This study is sponsored by Teva Pharmaceuticals Europe BV. M Ashina serves as a consultant and/or scientific advisor for Allergan/AbbVie, Amgen, Biohaven, Eli Lilly, Lundbeck, Novartis and Teva Pharmaceuticals; a principal investigator for Alder BioPharmaceuticals, Allergan/AbbVie, Amgen, Eli Lilly, Lundbeck, Novartis and Teva Pharmaceuticals; and an associate editor for Cephalalgia and for the Journal of Headache and Pain. M Ashina has no ownership interest and does not own stock in any pharmaceutical company. M Ashina is president of the International Headache Society. FM Amin has served on an advisory board for or received honoraria from Eli Lilly, Lundbeck, Novartis and Teva Pharmaceuticals. FM Amin has also served as a principal investigator for Phase IV trials for Novartis and Teva Pharmaceuticals. P Kokturk, JM Cohen, M Konings and L Lyras are employees of Teva Pharmaceuticals. C Tassorelli serves as a scientific consultant for Allergan/AbbVie, Eli Lilly, Lundbeck, Novartis and Teva Pharmaceuticals; and as a principal investigator or collaborator in clinical trials sponsored by Alder, Allergan/AbbVie, Amgen, Eli Lilly and Teva Pharmaceuticals. C Tassorelli has received research grants from the European Commission, the Italian Ministry of Health and the Italian Ministry of University. C Tassorelli has no ownership interest and does not own stock in any pharmaceutical company. She is president-elect of the International Headache Society. D-D Mitsikostas has received consulting fees, speaking fees and travel grants from Allergan, Amgen, Bayer, Biogen, Cefaly, electroCore, Eli Lilly, Genesis Pharma, Merck Serono, Merz, Mylan, Novartis, Roche, Sanofi Genzyme, Specifar and Teva Pharmaceuticals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Editorial assistance was provided by C Koch, of Cello Health Communications/MedErgy (Yardley, PA), which was in accordance with Good Publication Practice (GPP3) guidelines and funded by Teva Pharmaceuticals.
Ethical conduct of research
This study is being conducted in a manner that is consistent with all relevant global, regional, and national guidelines and regulations for conducting studies with humans. This is a noninterventional (observational) study that complies with Article 2(c) of Directive 2001/20/EC, the 2012 Guideline on Good Pharmacovigilance Practice and the 2016 Guideline on Good Pharmacoepidemiology Practice. The study also complies with the nature of noninterventional (observational) studies referred to in the International Conference on Harmonisation Harmonised Tripartite Guideline for Pharmacovigilance Planning (E2E). The study protocol was reviewed and approved by appropriate independent ethics committees and/or institutional review boards in the appropriate geographies, as required by local law. All study participants provided written informed consent for their clinical data to be recorded anonymously and for patient questionnaires (e.g., a headache diary) to be collected. Participants were informed of their right to withdraw their consent at any time during the study.