Abstract Details

Title Efficacy and Safety of Fremanezumab in Patients with Migraine and Obesity: Post Hoc Analysis of the Phase 3 HALO-LTS and FOCUS Clinical Trials

Topic Headache

Presentation(s) P8 - Poster Session 8 (5:30 PM-6:30 PM)

Poster/Presentation
Number 12-001

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.

Authors/Disclosures
Mario Ortega, PhD (Teva Pharmaceuticals) PRESENTER	Dr. Ortega has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Pablo Irimia Sieira (Clinica Universidad de Navarra)	No disclosure on file
Brad Torphy	Brad Torphy has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Axsome. Brad Torphy has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. The institution of Brad Torphy has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Brad Torphy has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Axsome. Brad Torphy has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Abbvie. The institution of Brad Torphy has received research support from Abbvie. The institution of Brad Torphy has received research support from Teva. The institution of Brad Torphy has received research support from Lilly. The institution of Brad Torphy has received research support from Pfizer.
Steve Barash (Teva)	Steve Barash has received personal compensation for serving as an employee of Teva. Steve Barash has stock in Teva.
Lynda Krasenbaum	Lynda Krasenbaum has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Hasan Akcicek	No disclosure on file
Melody Smith (Chicago Headache Center & Research Institute)	Melody Smith has nothing to disclose.
Xiaoping Ning (Teva pharmaceuticals)	Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical . Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical.
Verena Ramirez Campos, MD (Teva)	Dr. Ramirez Campos has received personal compensation for serving as an employee of teva.

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