Erenumab 70 mg demonstrates long-term safety and sustained benefit for chronic migraine in Asian patients
Background
Chronic migraine (CM) is a debilitating neurological disorder characterized by frequent, severe headaches, significantly impacting quality of life. Despite available preventive therapies, conventional treatments often have suboptimal efficacy or limiting side effects, leaving a significant unmet need. Erenumab, a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, has shown promise in migraine prevention. However, comprehensive long-term safety and effectiveness data, particularly within the Asian population, have been scarce, necessitating further investigation into its sustained clinical profile.
Study Design
This was an open-label extension (OLTP) of the Phase 3 DRAGON study, enrolling 456 adult patients with chronic migraine from China and other Asian countries. Following a 12-week double-blind phase, participants transitioned to the OLTP, receiving once-monthly subcutaneous injections of erenumab 70 mg. The median duration of exposure to erenumab was 79.9 weeks. Primary endpoints focused on long-term safety, assessed by collecting all adverse events (AEs) and serious AEs (SAEs), including their severity and relationship to treatment. Effectiveness outcomes were evaluated using the Clinical Global Impression (CGI) scale, encompassing severity (CGI-S), improvement (CGI-I), and efficacy index (CGI-E).
Results
Over a median exposure of 79.9 weeks, 328 (71.9%) patients reported at least one adverse event (AE) during the open-label treatment phase. AEs suspected to be related to erenumab treatment occurred in 69 (15.1%) patients. The most frequent treatment-related AE was constipation, affecting 34 (7.5%) patients. Discontinuation of the study drug due to AEs was observed in 13 (2.9%) patients. Notably, breast cancer was reported as an AE leading to discontinuation in 2 (0.4%) patients, though these were deemed not treatment-related. Serious AEs (SAEs) were reported in 45 (9.9%) patients during the OLTP, with only 3 (0.7%) of these being considered treatment-related, all of which resolved. The study also confirmed the continued clinical benefit of erenumab as assessed by Clinical Global Impression scores, indicating sustained effectiveness in this patient cohort.
Constipation was the most frequent treatment-related adverse event, affecting 7.5% of patients receiving erenumab 70 mg once-monthly.
Key Findings
- 456 Asian chronic migraine patients received erenumab 70 mg once-monthly for a median of 79.9 weeks.
- Overall, 71.9% of patients reported at least one AE, with 15.1% being treatment-related.
- Constipation was the most frequent treatment-related AE, affecting 7.5% of patients.
- Only 2.9% of patients discontinued the study drug due to AEs, and 0.7% of SAEs were treatment-related.
- Erenumab maintained continued clinical benefit in chronic migraine patients over the long term.
Why It Matters
This long-term open-label extension provides crucial reassurance regarding the sustained safety and effectiveness of erenumab for Asian patients with chronic migraine. The data supports erenumab 70 mg as a viable and well-tolerated preventive option, particularly for a population where such long-term evidence was previously limited. Clinicians can now consider erenumab with greater confidence for long-term management of chronic migraine in Asian patients. The once-monthly subcutaneous administration offers a convenient protocol, potentially improving adherence. While the study primarily focused on safety, the sustained clinical benefit observed suggests that patients can expect continued relief over extended periods, reinforcing its role in chronic migraine treatment strategies.
erenumab
chronic-migraine
cgrp-receptor-antagonist
asian-population
long-term-safety
open-label-extension