Erenumab and Fremanezumab Migraine Therapies Associated With Increased Blood Pressure

Patients using anti-calcitonin gene-related peptide (CGRP) receptor antibodies for the treatment of migraine may be at risk for elevated systolic and diastolic blood pressure (BP), according to results of a study published in Neurology.

All patients (n=196) receiving erenumab (n=109) or fremanezumab (n=87) for the treatment of migraine at the Leiden Headache Center in The Netherlands between 2019 and 2021 were assessed for change in BP from baseline to 12 months. Patients (n=109) who were not receiving anti-CGRP therapies were used as a comparator cohort. Erenumab was started at a 70-mg dose administered subcutaneously every 4 weeks with the option to increase to 140 mg at 3 months. Fremanezumab was administered at a 225-mg dose administered subcutaneously every 4 weeks.

The mean ages of patients in the erenumab and fremanezumab cohorts were 42±12.5 and 45±12.3 years, respectively; women made up 85% of both cohorts, and 51% and 55% had chronic migraine with 14±5.9 and 14±6.5 monthly migraine days and 17±6.3 and 18±6.9 monthly headache days.  Mean systolic BP was 118.8±13.8 and 125.5±14.5 mm Hg, and mean diastolic BP was 76.2±8.4 and 82.1±8.1 mm Hg at baseline, respectively.

Compared with baseline, systolic and diastolic BP values increased significantly — by 5.0 mm Hg and 3.3 mm Hg, respectively — at month 3 of anti-CGRP therapy (both P <.001) and remained elevated until month 12 (all P <.001).

Stratified by drug, results were consistent with the pooled analysis among erenumab recipients (all P <.001). For fremanezumab, diastolic BP was not significantly elevated at any point compared with baseline, whereas systolic BP was increased significantly at months 3 and 6 (both P <.01) but not at months 9 or 12 compared with baseline.

A total of 9 patients started antihypertensive drug treatment after initiating anti-CGRP therapy, among whom 5 had pre-existing hypertension and 4 had no evidence of hypertension prior to anti-CGRP therapy. All patients who started antihypertensive medications without prior evidence of hypertension received erenumab.

Among the control group, mean systolic BP was 121.3±14.9 mm Hg and mean diastolic BP was 77.0±9.9 mm Hg at baseline. No evidence of systolic (P =.70) or diastolic (P =.39) BP elevations was observed at follow-up.

This study was limited by the sample size, which was insufficient to evaluate the effect of erenumab dose on BP.

This study found evidence that systolic and diastolic BP values increased among patients taking erenumab or fremanezumab for the treatment of migraine. The study authors state that “[a]s migraine itself is associated with an increased risk for cardio- and cerebrovascular events, it is important to monitor the BP after starting treatment with CGRP targeting treatment to prevent increasing this risk.” These data suggest that the use of these drugs may not be advisable for patients with pre-existing hypertension.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.