A Prospective, Observational Study to Evaluate the Long-term Safety, Including Cardiovascular Safety, of Fremanezumab in Patients with Migraine in Routine Clinical Practice
Natan Kahan1, Lynda Krasenbaum2, Debra Braverman1, Steve Barash2, Susan Colilla2, Katja Jennissen3, Roshini Nellailingam4, Carolyn Rainville2, Verena Ramirez Campos2, Jill Frain2, Hasan Akcicek5, Pramod JM6
1Teva Branded Pharmaceutical Industries Ltd., 2Teva Branded Pharmaceutical Products R&D Inc., 3Teva Pharmaceuticals International GmbH, 4Teva UK Ltd., 5Teva Netherlands B.V., 6Teva Pharmaceutical Industries Ltd.
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.