Open AccessRandomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: The EMPOwER study
Author(s) -
Shuu Jiun Wang,
Artemio Roxas,
B. Saravia,
Byung-Kun Kim,
Debashish Chowdhury,
Naji Riachi,
MeiLing Sharon Tai,
Surat Tanprawate,
T. Tran Ngoc,
Yi Zhao,
Daniel D. Mikol,
Shaloo Pandhi,
Shihua Wen,
Subhayan Mondal,
Nadia Tenenbaum,
Peggy Hours-Zesiger
Publication year - 2021
Publication title -
cephalalgia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.57
H-Index - 125
eISSN - 1468-2982
pISSN - 0333-1024
DOI - 10.1177/03331024211024160
Subject(s) - migraine , medicine , placebo , clinical endpoint , clinical trial , adverse effect , alternative medicine , pathology
Objective EMPOwER, a double-blind, randomised, phase 3 study, evaluated the efficacy and safety of erenumab in adults with episodic migraine from Asia, the Middle East, and Latin America.Methods Randomised patients (N = 900) received monthly subcutaneous injections of placebo, erenumab 70 mg, or 140 mg (3:3:2) for 3 months. Primary endpoint was change from baseline in monthly migraine days at Month 3. Other endpoints included achievement of ≥50%, ≥75%, and 100% reduction in monthly migraine days, change in monthly acute migraine-specific medication treatment days, patient-reported outcomes, and safety assessment.Results At baseline, mean (standard deviation) age was 37.5 (9.9) years, 81.9% were women, and monthly migraine days was 8.2 (2.8). At Month 3, change from baseline in monthly migraine days (primary endpoint) was −3.1, −4.2, and −4.8 days for placebo, erenumab 70 mg, and erenumab 140 mg, respectively, with a statistically significant difference for erenumab versus placebo (P = 0.002 [70 mg], P < 0.001 [140 mg]). Both erenumab doses were also significantly superior to placebo on all secondary endpoints, including the proportion of patients achieving ≥50% reduction from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication treatment days and change from baseline in the Headache Impact Test-6™ scores. The safety profile of erenumab was comparable with placebo; no new safety signals were observed.Conclusions This study of erenumab in patients with episodic migraine from Asia, the Middle East, and Latin America met all primary and secondary endpoints. A consistent numerical benefit was observed with erenumab 140 mg versus erenumab 70 mg across all efficacy endpoints. These findings extend evidence of erenumab’s efficacy and safety to patients under-represented in previous trials. ClinicalTrials.gov identifier: NCT03333109