Abstract Details

Title 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

Topic Headache

Presentation(s) S31 - Advances in Migraine Therapeutics (4:18 PM-4:30 PM)

Poster/Presentation
Number 005

Background DRAGON study (NCT03867201) enrolled patients from China and other Asian countries that were not adequately represented in the global CM pivotal study (NCT02066415).

Objective DRAGON is a 12-week phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-monthly subcutaneous erenumab 70 mg in adult patients with chronic migraine (CM).

Design/Methods Eligible patients with CM (N=557) were randomized (1:1) to receive either erenumab 70 mg or placebo for 12 weeks. The primary endpoint was change from baseline in monthly migraine days (MMD). The secondary endpoints were proportion of patients with ≥50% reduction in MMD, change in monthly acute headache medication days, modified migraine disability assessment scores (mMIDAS), and safety. Assessments were done over the last 4 weeks of the double-blind treatment period.

Results Overall demographics and baseline characteristics were balanced between the erenumab 70 mg and placebo groups. At baseline, mean (±SD) age was 41.7 (±10.9) years, 81.5% (n=454) patients were women, and mean MMD was 19.21 (±5.41). The primary endpoint was met; patients in the erenumab 70 mg group had a significantly greater reduction in MMD from baseline compared to placebo. Moreover, patients in the erenumab 70 mg group had a significantly higher chance to achieve at least 50% reduction in MMD from baseline. Additionally, higher reductions in monthly acute headache medication days and mMIDAS scores were observed with erenumab 70 mg when compared to placebo. The safety and tolerability profile of erenumab 70 mg was overall similar to placebo, with the exception of constipation. Full study results will be presented during the congress.

Conclusions DRAGON study confirmed the efficacy and safety of erenumab 70 mg in adult patients with CM from China and other Asian countries. These results are consistent with previous pivotal studies.

Authors/Disclosures
Shihua Wen, PhD (Novartis) PRESENTER	Dr. Wen has received personal compensation for serving as an employee of novartis.
Shuu-Jiun Wang, MD	Dr. Wang has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli-Lilly. Dr. Wang has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Norvatis. Dr. Wang has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AbbVie. Dr. Wang has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Pfizer, Taiwan. The institution of Dr. Wang has received research support from Eli-Lilly. The institution of Dr. Wang has received research support from Norvatis.
Byung-kun Kim, MD (Eulji Hospital, Dept of Neurology)	Dr. Kim has nothing to disclose.
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Wendy Su	Prof. Su has received personal compensation for serving as an employee of Novartis. Prof. Su has received stock or an ownership interest from Novartis.
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