Investigating the Risk of Hypertension After Initiation of Erenumab in the Post-Market Setting
Nikita Chhabra1, Carolyn Mead-Harvey2, Courtney Iser3, Hallie Taylor1, Hira Chaudhary1, Aimen Vanood1, David Dodick1
1Neurology, 2Quantitative Health Sciences, Mayo Clinic, 3Mercy Clinic
Objective:
To determine the risk of hypertension after initiation of erenumab in patients with migraine.
Background:
Erenumab is a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor approved for the prevention of migraine in adults. CGRP is involved in the regulation of vasomotor tone under physiologic and pathologic conditions, including hypertension. While there has not been evidence of hypertension in preclinical models or clinical trials, post-marketing data suggests erenumab may be associated with hypertension. This had led to warning in the FDA prescribing information for erenumab.
Design/Methods:
This is an IRB-approved, retrospective study evaluating patients treated with erenumab between 2018-2021 at a tertiary headache department. Systolic and diastolic blood pressure (BP) were compared between the initial visit (prior to initiation of erenumab) and follow up visit (while on erenumab). Worsening BP was defined as moving from a lower stage to a higher stage of BP, as defined by the American Heart Association. Serious adverse vascular events (SAVE) were defined as coronary artery disease, myocardial infarction, stroke, and peripheral arterial disease. Multivariable ordinal logistic regression was used to model associations with change in blood pressure from baseline to follow-up.
Results:
A total of 335 patients were included in the final analysis (average age of 45.7 years, [SD 14.40], 83.9% female). At baseline, 20.9% (70/335) of patients had pre-existing hypertension. Average time to follow up was 30.6 weeks, (SD 29.87). Overall, 23.3% (78/335) of all patients had worsening of their blood pressure. There was no association between worsening blood pressure and pre-existing hypertension, gender, BMI, and age. Two patients had a SAVE (coronary artery disease and myocardial infarction).
Conclusions:
A substantial number of patients initiated on erenumab had worsening of blood pressure. This suggests need for BP monitoring in patients initiated on erenumab. Real-world data on other drugs that target CGRP or its receptor are needed.