Efficacy and Safety of Fremanezumab in Patients with Migraine and Obesity: Post Hoc Analysis of the Phase 3 HALO-LTS and FOCUS Clinical Trials
Palbo Irimia Sieira1, Bradley Torphy2, Mario Ortega3, Steve Barash3, Lynda Krasenbaum3, Hasan Akcicek4, Melody Smith2, Xiaoping Ning3, Verena Ramirez Campos3
1Clinica Universidad de Navarra, 2Chicago Headache Center and Research Institute, 3Teva Branded Pharmaceutical Products R&D Inc., 4Teva Netherlands B.V.
Objective:
This subgroup analysis evaluated the efficacy and safety of fremanezumab, a humanized monoclonal antibody targeting calcitonin gene‑related peptide, in patients with migraine and obesity (body mass index [BMI] ≥30 kg/m2 [BMI-high]).
Background:
A higher BMI is frequently associated with increased migraine prevalence and severity, and an increased number of adverse events (AEs).
Design/Methods:
This post hoc analysis included data from a subgroup of patients with migraine and obesity from two randomized, placebo-controlled trials: the 12-month Phase 3 HALO-LTS (NCT02638103) study and the 12-week Phase 3b FOCUS (NCT03308968) study. In each study, eligible patients with episodic or chronic migraine (EM, CM) were randomized to receive either monthly (CM: 675/225/225 mg; EM: 225/225/225 mg) or quarterly (675 mg) fremanezumab, or monthly matched placebo during the respective treatment periods. Key efficacy outcomes were change from baseline in mean monthly migraine days (MMD) and in headache days of at least moderate severity.
Results:
In total, 2437 patients (BMI-high, n=578; BMI <30 kg/m2 [BMI-normal], n=1859) received fremanezumab for migraine prevention. BMI-high patients had more self-reported comorbidities vs BMI-normal. Mean MMD at baseline were 13.7 (BMI-high) vs 13.6 (BMI-normal). At Month 6 (HALO-LTS data), BMI-high patients had a greater mean change from baseline in MMD vs BMI-normal patients (–6.9 vs –5.9). In BMI-high vs BMI-normal subgroups, mean headache days were 13.2 vs 13.4 at baseline, and 7.0 vs 7.4 at Month 6, with a mean change from baseline of –6.2 vs –5.6 at Month 6. Similar proportions of patients experienced AEs in the BMI-high (n=462 [80%]) and BMI-normal (n=1459 [78%]) subgroups.
Conclusions:
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.