Long-term safety and continued clinical benefit of erenumab 70 mg in Asian patients with chronic migraine: an open-label extension of the phase 3 DRAGON study
Abstract
Background: Erenumab is a fully human monoclonal antibody targeting the calcitonin gene-related peptide receptor. Several double-blind studies have demonstrated the clinical benefits of erenumab in migraine prevention. However, long-term studies on safety and effectiveness of erenumab are lacking in Asian population.
Objectives: To evaluate the long-term safety and continued clinical benefit of erenumab 70 mg in adult patients with chronic migraine (CM) in China and other Asian countries.
Methods: This was an open-label extension of the Phase 3 DRAGON study. Upon completion of the 12-week, double-blind treatment phase (DBTP) of the DRAGON study, randomized patients who met the inclusion criteria and provided consent transitioned into an open-label treatment phase (OLTP) lasting until erenumab approval in the patient's country. During OLTP, patients received once-monthly subcutaneous injection of erenumab 70 mg, irrespective of their initial treatment allocation in DBTP. Safety was assessed by collecting all adverse events (AEs) and serious AEs (SAEs) including their severity and relationship to study treatment. Effectiveness outcomes included clinical global impression (CGI) [severity (CGI-S), improvement (CGI-I), and efficacy index (CGI-E)].
Results: Of the 557 randomized patients (DBTP), 456 from 50 centers participated and 226 (49.6%) completed OLTP. The median duration of exposure to erenumab was 79.9 weeks (interquartile range: 39.9-130.5). Overall, 328 (71.9%) patients…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 557 participants or records.
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