Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study

Messoud Ashina; Dimos D. Mitsikostas; Faisal Mohammad Amin; Pinar Kokturk; Christoph J. Schankin; Gurdal Sahin; Patricia Pozo-Rosich; Paul J. Dorman; Tomáš Nežádal; Anne Christine Poole; Isabel Pavão Martins; Marja Liisa Sumelahti; Verena Ramirez Campos; Andrew H. Ahn; Leonidas Lyras; Cristina Tassorelli

doi:10.1177/03331024231214987

Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study

Messoud Ashina, Dimos D. Mitsikostas, Faisal Mohammad Amin, Pinar Kokturk, Christoph J. Schankin, Gurdal Sahin, Patricia Pozo-Rosich, Paul J. Dorman, Tomáš Nežádal, Anne Christine Poole, Isabel Pavão Martins, Marja Liisa Sumelahti, Verena Ramirez Campos, Andrew H. Ahn, Leonidas Lyras, Cristina Tassorelli

Research output: Contribution to journal › Article › peer-review

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 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.

Original language	English
Journal	Cephalalgia
Volume	43
Issue number	11
DOIs	https://doi.org/10.1177/03331024231214987
Publication status	Published - 2023 Nov

Bibliographical note

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.

Subject classification (UKÄ)

Neurology

Free keywords

Calcitonin gene-related peptide
chronic
episodic
real-world data
real-world evidence

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10.1177/03331024231214987

Cite this

Ashina, M., Mitsikostas, D. D., Amin, F. M., Kokturk, P., Schankin, C. J., Sahin, G., Pozo-Rosich, P., Dorman, P. J., Nežádal, T., Poole, A. C., Martins, I. P., Sumelahti, M. L., Ramirez Campos, V., Ahn, A. H., Lyras, L., & Tassorelli, C. (2023). Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study. Cephalalgia, 43(11). https://doi.org/10.1177/03331024231214987

@article{e64dd10c042c4301995dd9dbc23b510b,

title = "Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study",

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 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.",

keywords = "Calcitonin gene-related peptide, chronic, episodic, real-world data, real-world evidence",

author = "Messoud Ashina and Mitsikostas, {Dimos D.} and Amin, {Faisal Mohammad} and Pinar Kokturk and Schankin, {Christoph J.} and Gurdal Sahin and Patricia Pozo-Rosich and Dorman, {Paul J.} and Tom{\'a}{\v s} Ne{\v z}{\'a}dal and Poole, {Anne Christine} and Martins, {Isabel Pav{\~a}o} and Sumelahti, {Marja Liisa} and {Ramirez Campos}, Verena and Ahn, {Andrew H.} and Leonidas Lyras and Cristina Tassorelli",

note = "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: {\textcopyright} International Headache Society 2023.",

year = "2023",

month = nov,

doi = "10.1177/03331024231214987",

language = "English",

volume = "43",

journal = "Cephalalgia",

issn = "0333-1024",

publisher = "Wiley-Blackwell",

number = "11",

}

Ashina, M, Mitsikostas, DD, Amin, FM, Kokturk, P, Schankin, CJ, Sahin, G, Pozo-Rosich, P, Dorman, PJ, Nežádal, T, Poole, AC, Martins, IP, Sumelahti, ML, Ramirez Campos, V, Ahn, AH, Lyras, L & Tassorelli, C 2023, 'Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study', Cephalalgia, vol. 43, no. 11. https://doi.org/10.1177/03331024231214987

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 - 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.

PY - 2023/11

Y1 - 2023/11

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 - Article

C2 - 37987641

AN - SCOPUS:85177638192

SN - 0333-1024

VL - 43

JO - Cephalalgia

JF - Cephalalgia

IS - 11

ER -

Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study

Abstract

Bibliographical note

Subject classification (UKÄ)

Free keywords

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