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The safety and efficacy of 70 mg monthly erenumab for the treatment of chronic migraine was confirmed among an Asian population in a phase 3 trial, according to study results presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, held from April 2 to April 7 in Seattle, Washington, and virtually from April 24-26, 2022.
A previous trial found erenumab to be safe and effective for the treatment of chronic migraine but the trial was found to underrepresent patients with Asian ancestry. In order to specifically assess the safety and efficacy of erenumab among an Asian population, the DRAGON study (ClinicalTrials.gov Identifier: NCT03867201) recruited patients with chronic migraine from China and other Asian countries.
Asian patients (N=557) with chronic migraine were randomized in a 1:1 ratio to receive monthly subcutaneous injections of 70 mg erenumab or placebo for 12 weeks. The primary endpoint was change in monthly migraine days (MMD) and the secondary endpoints were monthly use of acute headache medication, change in modified migraine disability assessment scores (mMIDAS), and safety. A 50% or more reduction in MMD was defined as a clinically significant change.
Baseline characteristics were well balanced, and the entire study population was aged mean 41.7±10.9 years, 81.5% were women, and they experienced 19.21±5.41 MMD on average.
At 12 weeks, patients who received erenumab had a significant reduction in MMD compared with placebo. The erenumab group were more likely to report a 50% or more reduction in MMD, a reduction in the number of days they took acute medication for headache symptoms, and a lower mMIDAS scores compared with placebo group individuals.
The safety and tolerability profiles were similar between the active treatment and placebo groups.
This study was limited by its relatively small sample size and short study duration.
“DRAGON study confirmed the efficacy and safety of erenumab 70 mg in adult patients with CM from China and other Asian countries,” the researchers stated. “These results are consistent with previous pivotal studies.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Wang S-J, Kim B-K, Wang H, et al. Efficacy and Safety of Erenumab 70 mg in Adult Patients with Chronic Migraine: Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled DRAGON Study. Presented at: the 2022 AAN Annual Meeting; April 2-7, 2022; Seattle, Washington; April 24-26, 2022; Virtual Meeting. Abstract S31.005.