Early and Sustained Shift in Headache Day Frequency Following Eptinezumab Treatment in Adults With Migraine for Whom 2-4 Previous Preventive Treatments Have Failed: A Post Hoc Analysis of the Randomized DELIVER Trial.

BACKGROUND

This post hoc analysis examined the reduction in monthly headache days (MHDs) by frequency category shifts and associated improvements following eptinezumab treatment.

METHODS

The DELIVER trial evaluated eptinezumab in adults with migraine for whom 2-4 previous preventive treatments failed. During a 24-week, double-blind, placebo-controlled period followed by a 48-week extension period, participants received IV eptinezumab 100 mg, 300 mg, or placebo every 12 weeks, with all receiving eptinezumab beginning Week 25 (dose-blinded). Participants were categorized by MHD frequency: > 14, 8-14, 4 to < 8, 1 to < 4, 0. MHD category shifts were evaluated in the total population and several subgroups (including participants with > 14 baseline MHDs and early ≥ 50% responders). In participants reporting < 8 MHDs after all doses, the associated changes in headache intensity and disease status were evaluated.

RESULTS

Of randomized participants, 88% (782/890) completed the trial. The percentage of participants randomized initially to eptinezumab who reported < 4 MHDs was 23% (138/592) over Weeks 1-12 and 47% (236/498) over Weeks 61-72; 9% reported 0 MHDs after the final dose. Of participants randomized initially to eptinezumab who shifted from ≥ 8 MHDs at baseline to < 8 over Weeks 1-12, 71% (170/241) reported < 8 MHDs for the rest of the trial; of those who shifted from > 14 to < 8 MHDs, 66% (49/74) reported < 8 MHDs for the rest of the trial. Reduction to < 8 MHDs was associated with robust improvements in headache intensity and disease burden.

CONCLUSIONS

Eptinezumab was associated with sustained reduction in MHD category, with some achieving headache/migraine freedom in patients with a history of preventive treatments that failed.

TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT04418765; https://www.

CLINICALTRIALS: gov/ct2/show/NCT04418765) and EudraCT (identifier: 2019-004497-25; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004497-25).