Safety, Efficacy of Fremanezumab Supported in Patients With Migraine and Obesity

Fremanezumab is found to be safe and effective in patients with migraine and obesity, according to study results presented at the 2024 American Academy of Neurology (AAN) annual meeting, held from April 13 to 18, 2024, in Denver, Colorado.

Previous research has shown that a higher body mass index (BMI) is associated with increased prevalence and severity of migraine.

Researchers conducted a post-hoc analysis to determine the safety and efficacy of fremanezumab in patients with migraine and obesity (BMI ≥30).

Data from the phase 3 HALO-LTS and phase 3b FOCUS trials (ClinicalTrials.gov Identifiers: NCT02638103 and NCT03308968, respectively) were used to identify participants with migraine and obesity for this subgroup analysis. Eligible participants had episodic or chronic migraine and were randomly assigned to receive monthly or quarterly fremanezumab or placebo.

Study outcome was mean change from baseline in monthly migraine and headache days of moderate severity.

A total of 2437 patients (578 with BMI ≥30 and 1859 with BMI <30) received fremanezumab for migraine prevention. Mean monthly migraine days at baseline were greater in patients with higher vs lower BMI (13.7 vs 13.6 days).

At month 6, patients with higher vs lower BMI had a greater mean change from baseline in monthly migraine days (-6.9 vs -5.9 days) and headache days (-6.2 vs 5.6 days).

Rate of adverse events was similar among patients with higher and lower BMI (80% and 78%, respectively).

“This analysis demonstrates that fremanezumab is efficacious and well tolerated over 6 months in patients with both migraine and obesity, consistent with outcomes from other pivotal fremanezumab studies. These data support the use of fremanezumab for migraine prevention in a wide population of patients,” the researchers concluded.