TY - JOUR
T1 - Risk of hypertension in erenumab-treated patients with migraine
T2 - Analyses of clinical trial and postmarketing data
AU - Dodick, David W.
AU - Tepper, Stewart J.
AU - Ailani, Jessica
AU - Pannacciulli, Nicola
AU - Navetta, Marco S.
AU - Loop, Brett
AU - Zhang, Feng
AU - Khodavirdi, Ani C.
AU - Mann, Allison
AU - Abdrabboh, Ahmad
AU - Kalim, Jawed
N1 - Publisher Copyright:
© 2021 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society
PY - 2021/10
Y1 - 2021/10
N2 - Objective: To assess the risk of hypertension in patients with migraine who received erenumab in clinical trials and in the postmarketing setting. Background: Erenumab is a monoclonal antibody for migraine prevention that targets the calcitonin gene-related peptide (CGRP) receptor. Hypertension is a theoretical risk for inhibitors of the CGRP pathway. Although no evidence of an association between erenumab treatment and hypertension was observed during the clinical development program, adverse events (AEs) of hypertension have been identified in the postmarketing setting. Methods: Safety data from four phase 2 and phase 3 clinical trials were used to perform a pooled analysis of hypertension AEs in patients with migraine receiving erenumab. Postmarketing AEs of hypertension were identified from the Amgen Global Safety database from May 17, 2018, through January 31, 2020. Results: In the pooled analysis of clinical trials, hypertension AEs (placebo, 9/1043 [0.9%]; erenumab 70 mg, 7/893 [0.8%]; erenumab 140 mg, 1/507 [0.2%]) and percentage of patients initiating medication to treat hypertension (12/1043 [1.2%], 7/893 [0.8%], 1/507 [0.2%], respectively) were similar across treatment groups. A total of 362 AEs of hypertension were identified from the postmarketing setting, 26.2% (95/362) of which were serious, >245,000 patient-years of exposure. The exposure-adjusted incidence of hypertension was 0.144 per 100 patient-years. Conclusions: Clinical trials did not demonstrate an increased risk of hypertension with erenumab compared with placebo, and AE rates of hypertension reported with erenumab in the postmarketing setting were generally low. Additional data are needed to fully characterize the extent to which hypertension is a risk associated with erenumab.
AB - Objective: To assess the risk of hypertension in patients with migraine who received erenumab in clinical trials and in the postmarketing setting. Background: Erenumab is a monoclonal antibody for migraine prevention that targets the calcitonin gene-related peptide (CGRP) receptor. Hypertension is a theoretical risk for inhibitors of the CGRP pathway. Although no evidence of an association between erenumab treatment and hypertension was observed during the clinical development program, adverse events (AEs) of hypertension have been identified in the postmarketing setting. Methods: Safety data from four phase 2 and phase 3 clinical trials were used to perform a pooled analysis of hypertension AEs in patients with migraine receiving erenumab. Postmarketing AEs of hypertension were identified from the Amgen Global Safety database from May 17, 2018, through January 31, 2020. Results: In the pooled analysis of clinical trials, hypertension AEs (placebo, 9/1043 [0.9%]; erenumab 70 mg, 7/893 [0.8%]; erenumab 140 mg, 1/507 [0.2%]) and percentage of patients initiating medication to treat hypertension (12/1043 [1.2%], 7/893 [0.8%], 1/507 [0.2%], respectively) were similar across treatment groups. A total of 362 AEs of hypertension were identified from the postmarketing setting, 26.2% (95/362) of which were serious, >245,000 patient-years of exposure. The exposure-adjusted incidence of hypertension was 0.144 per 100 patient-years. Conclusions: Clinical trials did not demonstrate an increased risk of hypertension with erenumab compared with placebo, and AE rates of hypertension reported with erenumab in the postmarketing setting were generally low. Additional data are needed to fully characterize the extent to which hypertension is a risk associated with erenumab.
KW - blood pressure
KW - calcitonin gene-related peptide
KW - drug safety
KW - hypertension
KW - individual case safety report
KW - postmarketing surveillance
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U2 - 10.1111/head.14208
DO - 10.1111/head.14208
M3 - Article
C2 - 34591982
AN - SCOPUS:85116192291
SN - 0017-8748
VL - 61
SP - 1411
EP - 1420
JO - Headache
JF - Headache
IS - 9
ER -