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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 LU orcid ; Pozo-Rosich, Patricia ; Dorman, Paul J. ; Nežádal, Tomáš and Poole, Anne Christine , et al. (2023) In Cephalalgia 43(11).
Abstract

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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Calcitonin gene-related peptide, chronic, episodic, real-world data, real-world evidence
in
Cephalalgia
volume
43
issue
11
publisher
Wiley-Blackwell
external identifiers
  • pmid:37987641
  • scopus:85177638192
ISSN
0333-1024
DOI
10.1177/03331024231214987
language
English
LU publication?
yes
additional info
Funding Information: Medical writing and editorial support for the development of this manuscript, under the direction of the authors, was provided by Molly Clark, Sophie Roberts, and Olivia Morris of Ashfield MedComms, an Inizio company, and funded by Teva Pharmaceuticals. Publisher Copyright: © International Headache Society 2023.
id
e64dd10c-042c-4301-995d-d9dbc23b510b
date added to LUP
2024-01-03 09:56:03
date last changed
2024-04-18 07:19:17
@article{e64dd10c-042c-4301-995d-d9dbc23b510b,
  abstract     = {{<p>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.</p>}},
  author       = {{Ashina, Messoud and Mitsikostas, Dimos D. and Amin, Faisal Mohammad and Kokturk, Pinar and Schankin, Christoph J. and Sahin, Gurdal and Pozo-Rosich, Patricia and Dorman, Paul J. and Nežádal, Tomáš and Poole, Anne Christine and Martins, Isabel Pavão and Sumelahti, Marja Liisa and Ramirez Campos, Verena and Ahn, Andrew H. and Lyras, Leonidas and Tassorelli, Cristina}},
  issn         = {{0333-1024}},
  keywords     = {{Calcitonin gene-related peptide; chronic; episodic; real-world data; real-world evidence}},
  language     = {{eng}},
  number       = {{11}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{Cephalalgia}},
  title        = {{Real-world effectiveness of fremanezumab for the preventive treatment of migraine : Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study}},
  url          = {{http://dx.doi.org/10.1177/03331024231214987}},
  doi          = {{10.1177/03331024231214987}},
  volume       = {{43}},
  year         = {{2023}},
}