Abstract Details

Title A Prospective, Observational Study to Evaluate the Long-term Safety, Including Cardiovascular Safety, of Fremanezumab in Patients with Migraine in Routine Clinical Practice

Topic Headache

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

Poster/Presentation
Number 12-007

Objective This post-authorization safety study was developed to evaluate the long-term safety, including cardiovascular (CV) safety, of fremanezumab in real-world clinical practice.

Background Fremanezumab is a humanized mAb that targets the calcitonin gene-related peptide (CGRP) pathway and is authorized for preventive treatment of migraine in adults.

Design/Methods In this controlled prospective cohort study in the US, Spain, and Canada, patients with migraine aged ≥18 years were grouped into three cohorts based on their preventive migraine medication: fremanezumab, other CGRP pathway medications (that target CGRP or its receptor), and other migraine preventive medications. Each cohort was divided into two sub-populations: CV compromised (patients with a history or current diagnosis of major CV disease and/or hypertension [HTN]) and non-CV-compromised patients. The aim was to enroll 6000 patients, 725 non-CV-compromised and 1275 CV-compromised in each cohort. Follow-up was planned for at least 3 years. Concomitant medications, comorbidities, and all adverse events (AEs) were electronically recorded. To assess worsening of pre existing HTN, blood pressure (BP) values measured during office visits were documented. Patients were consented and enrolled at the physician visit when the cohort drug was initially prescribed. Rates of AEs were calculated for all cohorts stratified by the CV subpopulations.

Results Over 30 months, only 1077 patients were enrolled. The study was terminated due to low enrollment rates, primarily of CV-compromised patients (N=342). Mean duration of follow-up in the fremanezumab cohort (N=374) was 396.9 days (minimum; maximum: 23; 857). No new safety trends or previously undocumented AEs were observed. Routine BP measurement was generally not part of standard of care which impeded evaluation of the BP outcomes.

Conclusions No new safety findings in patients treated with fremanezumab were detected. With the current interest in the effects of CGRP pathway targeted medications on BP, measurements of BP should be encouraged as part of a routine migraine office visit.

Authors/Disclosures
Verena Ramirez Campos, MD (Teva) PRESENTER	Dr. Ramirez Campos has received personal compensation for serving as an employee of teva.
Natan Kahan (Teva Branded Pharmaceutical Industries Ltd.)	No disclosure on file
Lynda Krasenbaum	Lynda Krasenbaum has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Debra Braverman (Teva Pharmaceutical Industries)	No disclosure on file
Steve Barash (Teva)	Steve Barash has received personal compensation for serving as an employee of Teva. Steve Barash has stock in Teva.
Susan Colilla (Teva Pharmaceuticals)	No disclosure on file
Katja Jennissen (Teva Pharmaceuticals International GmbH)	No disclosure on file
Roshini Nellailingam (Teva UK Ltd)	No disclosure on file
Carolyn Rainville (Teva Pharmaceuticals)	No disclosure on file
Jill Frain (Teva Pharmaceuticals)	No disclosure on file
Hasan Akcicek	No disclosure on file
Pramod Jm (Teva)	No disclosure on file

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