Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study
Jazyk angličtina Země Anglie, Velká Británie Médium print
Typ dokumentu pozorovací studie, klinické zkoušky, fáze IV, časopisecké články
- Klíčová slova
- Calcitonin gene-related peptide, chronic, episodic, real-world data, real-world evidence,
- MeSH
- bolesti hlavy MeSH
- dospělí MeSH
- lidé MeSH
- migréna * farmakoterapie prevence a kontrola MeSH
- monoklonální protilátky * MeSH
- prospektivní studie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze IV MeSH
- pozorovací studie MeSH
- Názvy látek
- fremanezumab MeSH Prohlížeč
- monoklonální protilátky * MeSH
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.
Centro de Estudos Egas Moniz Faculty of Medicine University of Lisbon Lisbon Portugal
Department of Brain and Behavioral Sciences University of Pavia Pavia Italy
Department of Clinical Medicine University of Copenhagen Copenhagen Denmark
Department of Clinical Sciences of Lund Lund University Skåneuro Neurology Clinic Lund Sweden
Department of Neurology Inselspital University Hospital Bern University of Bern Bern Switzerland
Faculty of Medicine and Health Technology University of Tampere Tampere Finland
Institute of Neuropsychiatric Care 1st Faculty of Medicine Charles University Prague Czech Republic
IRCCS Mondino Foundation Pavia Italy
Private Practice Oslo Headache Centre Oslo Norway
Teva Branded Pharmaceutical Products R and D Inc West Chester PA USA
Teva Netherlands B 5 Amsterdam Netherlands
The Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle upon Tyne UK
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