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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Real-world effectiveness of fremanezumab for the preventive treatment of migraine : Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study. / 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.
I: Cephalalgia, Bind 43, Nr. 11, 2023.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Real-world effectiveness of fremanezumab for the preventive treatment of migraine
T2 - Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study
AU - Ashina, Messoud
AU - Mitsikostas, Dimos D.
AU - Amin, Faisal Mohammad
AU - Kokturk, Pinar
AU - Schankin, Christoph J.
AU - Sahin, Gurdal
AU - Pozo-Rosich, Patricia
AU - Dorman, Paul J.
AU - Nežádal, Tomáš
AU - Poole, Anne Christine
AU - Martins, Isabel Pavão
AU - Sumelahti, Marja Liisa
AU - Ramirez Campos, Verena
AU - Ahn, Andrew H.
AU - Lyras, Leonidas
AU - Tassorelli, Cristina
N1 - Publisher Copyright: © International Headache Society 2023.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - Calcitonin gene-related peptide
KW - chronic
KW - episodic
KW - real-world data
KW - real-world evidence
U2 - 10.1177/03331024231214987
DO - 10.1177/03331024231214987
M3 - Journal article
C2 - 37987641
AN - SCOPUS:85177638192
VL - 43
JO - Cephalalgia
JF - Cephalalgia
SN - 0800-1952
IS - 11
ER -
ID: 379081299