Sistema de Salut de Catalunya
Institut Català de la Salut
[Ashina M] Department of Neurology, Danish Headache Center, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. [Mitsikostas DD] First Department of Neurology, Aeginition Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece. [Amin FM] Department of Neurology, Danish Headache Center, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. Department of Neurorehabilitation/Traumatic Brain Injury, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. [Kokturk P] Teva Netherlands B.V., Amsterdam, Netherlands. [Schankin CJ] Department of Neurology, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland. [Sahin G] Department of Clinical Sciences of Lund, Lund University, Skåneuro Neurology Clinic, Lund, Sweden. [Pozo-Rosich P] Grup de Recerca de Cefalea i Dolor Neurològic, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain
Vall d'Hebron Barcelona Hospital Campus
2024-01-08T10:41:14Z
2024-01-08T10:41:14Z
2023-11
Chronic; Episodic; Real-world evidence
Crònica; Episòdic; Evidència del món real
Crónico; Episódico; Evidencia del mundo real
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
Article
Published version
English
Migranya - Prevenció; Migranya - Tractament; Anticossos monoclonals - Ús terapèutic; CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal; DISEASES::Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Headache Disorders::Headache Disorders, Primary::Migraine Disorders; Other subheadings::Other subheadings::Other subheadings::/prevention & control; COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales; ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos con cefaleas::cefaleas primarias::trastornos migrañosos; Otros calificadores::Otros calificadores::Otros calificadores::/prevención & control
SAGE Publications
Cephalalgia;43(11)
https://doi.org/10.1177/03331024231214987
Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
Articles científics - VHIR [1655]
