Shift in MHDs below the threshold of preventive optimization after eptinezumab treatment in patients with migraine and history of 2–4 preventive migraine treatment failures
Amaal Starling1, Divya Asher2, Susanne Awad3, Xin Ying Lee3, Peter Goadsby4, Bjorn Sperling3
1Mayo Clinic, 2Lundbeck LLC, 3H. Lundbeck A/S, 4University of California, Los Angeles

To determine the shift in headache frequency categories among eptinezumab-treated patients within the DELIVER clinical trial.


Preventive treatment can be considered optimized when patients reach <4 monthly headache days (MHDs). In the DELIVER trial of patients with migraine (episodic and chronic) and 2–4 prior preventive migraine treatment trials, eptinezumab reduced migraine and headache frequency more than placebo, with reductions sustained during an 18-month open-label treatment period.

Randomized patients received eptinezumab 100 mg (n=299), 300 mg (n=293), or placebo (n=298) over a 24-week, placebo-controlled period, with placebo patients randomized to eptinezumab 100 or 300 mg for a 48-week, dose-blinded extension period. Patients were classified by number of MHDs reported. Headache frequency categories were: 0, 1–3, 4–7, 8–14, and ≥15 MHDs. Every 12-week dosing interval, the percentage of patients within each category was calculated.

Of those initially randomized to eptinezumab in the placebo-controlled period, 0% of patients experienced ≤3 MHDs at baseline per the inclusion criteria, 20% after the first dose (Weeks 1–12), and 44% by study conclusion (Weeks 61–72). The percentage of patients experiencing ≥8 MHDs at baseline decreased from 92% at baseline to 49% after the first dose and to 28% by the last dose. Of those initially randomized to placebo in the placebo-controlled period, 29% experienced ≤3 MHDs after their first eptinezumab dose (Weeks 25–36) and 43% by Weeks 61–72. Of patients with chronic migraine at baseline and randomized to eptinezumab (n=271), 80% experienced ≤14 MHDs by Weeks 61–72.


Eptinezumab treatment led to sustained improvements and downward shifts in MHDs relative to baseline, with many patients reaching preventive treatment optimization (<4 MHDs). Most patients with chronic migraine at baseline no longer met those diagnostic criteria (≥15 MHDs) by the end of the study.