TY - JOUR

T1 - PEARL study protocol

T2 - A real-world study of fremanezumab effectiveness in patients with chronic or episodic migraine

AU - Ashina, Messoud

AU - Amin, Faisal Mohammad

AU - Kokturk, Pinar

AU - Cohen, Joshua M.

AU - Konings, Martijn

AU - Tassorelli, Cristina

AU - Lyras, Leonidas

AU - Mitsikostas, DImos Dimitrios

N1 - Publisher Copyright: © 2021

PY - 2021

Y1 - 2021

N2 - Lay abstract Fremanezumab is an injectable biologic medication that targets calcitonin gene-related peptide, a substance released in the nerves and blood vessels during a migraine attack that plays a role in migraine pain. Fremanezumab is approved in Europe for preventing migraine in adults who experience ≥4 migraine days/month. The Pan-European Real Life (PEARL) study is a 24-month long study that will observe patients with migraine who are starting treatment with fremanezumab in a clinical practice setting under the care of their treating physician. The major goals of the study are to evaluate the effectiveness of fremanezumab for reducing days with migraine attacks in a month, disability associated with migraine and use of acute headache medications to treat migraine, including in patients switching from other biologic migraine therapies in the same drug class. The extent to which patients follow their recommended treatment schedule per their providers' instructions and whether patients discontinue treatment will also be evaluated. The PEARL study will include >1000 patients in 100 centers across 11 European countries. The study will provide important information on effectiveness for patients with migraine receiving fremanezumab in the normal course of their treatment, as well as on patients' use of fremanezumab according to their prescribing physicians' recommendations. Trial registration number: EUPAS35111 (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.

AB - Lay abstract Fremanezumab is an injectable biologic medication that targets calcitonin gene-related peptide, a substance released in the nerves and blood vessels during a migraine attack that plays a role in migraine pain. Fremanezumab is approved in Europe for preventing migraine in adults who experience ≥4 migraine days/month. The Pan-European Real Life (PEARL) study is a 24-month long study that will observe patients with migraine who are starting treatment with fremanezumab in a clinical practice setting under the care of their treating physician. The major goals of the study are to evaluate the effectiveness of fremanezumab for reducing days with migraine attacks in a month, disability associated with migraine and use of acute headache medications to treat migraine, including in patients switching from other biologic migraine therapies in the same drug class. The extent to which patients follow their recommended treatment schedule per their providers' instructions and whether patients discontinue treatment will also be evaluated. The PEARL study will include >1000 patients in 100 centers across 11 European countries. The study will provide important information on effectiveness for patients with migraine receiving fremanezumab in the normal course of their treatment, as well as on patients' use of fremanezumab according to their prescribing physicians' recommendations. Trial registration number: EUPAS35111 (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.

KW - adherence

KW - calcitonin gene-related peptide

KW - chronic

KW - episodic

KW - fremanezumab

KW - migraine

KW - persistence

KW - real world

UR - http://www.scopus.com/inward/record.url?scp=85115661814&partnerID=8YFLogxK

U2 - 10.2217/pmt-2021-0015

DO - 10.2217/pmt-2021-0015

M3 - Journal article

C2 - 34105377

AN - SCOPUS:85115661814

VL - 11

SP - 647

EP - 654

JO - Pain Management

JF - Pain Management

SN - 1758-1869

IS - 6

ER -