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 -