Abstract Details

The multi-site, randomized, parallel-group, double-blinded, placebo-controlled DELIVER clinical trial (NCT04418765) enrolled patients with documented failure of 2–4 prior preventive migraine therapies. DELIVER demonstrated that patients treated with eptinezumab had significant improvements in efficacy measures, including reductions in mean monthly migraine days (MMDs) and achievement of ≥50% migraine response compared to placebo, over 18 months.

To evaluate the 18-month maintenance of ≥50% migraine response in patients who experienced ≥50% migraine response with early doses of eptinezumab.  

Randomized patients received eptinezumab 100 mg, 300 mg, or placebo (IV every 12 weeks) over 24 weeks prior to entering a 48-week dose-blinded extension phase. The ≥50% migraine response rates (i.e., percentage of patients with ≥50% reduction from baseline in MMDs) were calculated using the average percentage change from baseline in MMDs for each 4-week period within a 12-week dosing interval using logistic regression analysis. The number of dosing intervals with ≥50% migraine response was calculated for patients experiencing ≥50% migraine response during Weeks 1–12 or 1–24. Data were limited to eptinezumab-treated patients with data for all timepoints for the entire 12-month extension (83% of patients). 

For ≥50% migraine responders within the first eptinezumab dose (over Weeks 1–12), 61% and 74% maintained their ≥50% response to eptinezumab 100 mg (n=113) and eptinezumab 300 mg (n=126), respectively, for the full 18-month study duration. For ≥50% migraine responders within the first two doses of eptinezumab (over Weeks 1–24), the percent of patients who maintained their ≥50% responder status over the remaining 4 doses (18-month study duration) was 69% (100 mg, n=128) and 82% (300 mg, n=131).

In most patients, clinical response (≥50% reduction in MMDs) to eptinezumab preventive treatment was maintained if patients experienced a ≥50% migraine response after receiving just 1–2 doses of eptinezumab.