Ashina, Messoud; Mitsikostas, Dimos D; Amin, Faisal Mohammad; Kokturk, Pinar; Schankin, Christoph J; Sahin, Gurdal; Pozo-Rosich, Patricia; Dorman, Paul J; Nežádal, Tomáš; Poole, Anne Christine; Martins, Isabel Pavão; Sumelahti, Marja-Liisa; Ramirez Campos, Verena; Ahn, Andrew H; Lyras, Leonidas; Tassorelli, Cristina (2023). Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study. Cephalalgia : an international journal of headache, 43(11), p. 3331024231214987. International Headache Society 10.1177/03331024231214987
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BACKGROUND
The ongoing Pan-European Real Life (PEARL) phase 4 study is evaluating fremanezumab effectiveness and safety for the prevention of episodic and chronic migraine. This interim analysis reports primary, secondary and exploratory endpoints from when 500 participants completed at least six months of treatment.
METHODS
Adults with episodic migraine or chronic migraine maintaining daily headache diaries were enrolled upon initiation of fremanezumab. Primary endpoint: proportion of participants with ≥50% reduction in monthly migraine days during the six-month period after fremanezumab initiation. Secondary endpoints: mean change from baseline across months 1-12 in monthly migraine days, acute migraine medication use, and headache-related disability. Exploratory endpoint: mean change in headache severity from baseline across months 1-12. Safety was assessed through adverse events reported.
RESULTS
Overall, 897 participants were enrolled and 574 included in the effectiveness analyses (episodic migraine, 25.8%; chronic migraine, 74.2%). Of participants with data available, 175/313 (55.9%) achieved ≥50% monthly migraine days reduction during the six-month period post-initiation. Across months 1-12, there were sustained reductions in mean monthly migraine days, acute medication use, disability scores, and headache severity. Few adverse events were reported.
CONCLUSION
PEARL interim results support the effectiveness and safety of fremanezumab for migraine prevention in a real-world population across several European countries.Trial registration: encepp.eu: EUPAS35111.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology |
UniBE Contributor: |
Schankin, Christoph Josef |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
1468-2982 |
Publisher: |
International Headache Society |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
22 Nov 2023 10:24 |
Last Modified: |
26 Nov 2023 02:26 |
Publisher DOI: |
10.1177/03331024231214987 |
PubMed ID: |
37987641 |
Uncontrolled Keywords: |
Calcitonin gene-related peptide chronic episodic real-world data real-world evidence |
BORIS DOI: |
10.48350/189252 |
URI: |
https://boris.unibe.ch/id/eprint/189252 |
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