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Real-world effectiv...
Real-world effectiveness of fremanezumab for the preventive treatment of migraine : Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study
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- Ashina, Messoud (författare)
- University of Copenhagen,Copenhagen University Hospital
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- Mitsikostas, Dimos D. (författare)
- Eginition Hospital
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- Amin, Faisal Mohammad (författare)
- Copenhagen University Hospital
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- Kokturk, Pinar (författare)
- Teva Netherlands B.V.
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- Schankin, Christoph J. (författare)
- Bern University Hospital
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- Sahin, Gurdal (författare)
- Lund University,Lunds universitet,Integrativ neurofysiologi,Forskargrupper vid Lunds universitet,Neurologi, Lund,Sektion IV,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Regeneration in Movement Disorders,Integrative Neurophysiology,Lund University Research Groups,Neurology, Lund,Section IV,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital
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- Pozo-Rosich, Patricia (författare)
- Autonomous University of Barcelona
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- Dorman, Paul J. (författare)
- Newcastle upon Tyne Hospitals NHS Trust
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- Nežádal, Tomáš (författare)
- Charles University in Prague
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- Poole, Anne Christine (författare)
- Oslo Headache Centre
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- Martins, Isabel Pavão (författare)
- University of Lisbon
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- Sumelahti, Marja Liisa (författare)
- University of Tampere
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- Ramirez Campos, Verena (författare)
- Teva Pharmaceuticals
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- Ahn, Andrew H. (författare)
- Teva Pharmaceuticals
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- Lyras, Leonidas (författare)
- Teva Netherlands B.V.
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- Tassorelli, Cristina (författare)
- University of Pavia
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(creator_code:org_t)
- 2023
- 2023
- Engelska.
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Ingår i: Cephalalgia. - 0333-1024. ; 43:11
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
Nyckelord
- Calcitonin gene-related peptide
- chronic
- episodic
- real-world data
- real-world evidence
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- art (ämneskategori)
- ref (ämneskategori)
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Ashina, Messoud
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Mitsikostas, Dim ...
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Amin, Faisal Moh ...
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Kokturk, Pinar
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Schankin, Christ ...
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Sahin, Gurdal
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Pozo-Rosich, Pat ...
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Dorman, Paul J.
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Nežádal, Tomáš
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Poole, Anne Chri ...
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Martins, Isabel ...
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Sumelahti, Marja ...
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Ramirez Campos, ...
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Ahn, Andrew H.
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Lyras, Leonidas
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Tassorelli, Cris ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Neurologi
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Cephalalgia
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Lunds universitet