To evaluate migraine responder rates (RRs) in episodic migraine (EM) and chronic migraine (CM) over Weeks (Wks) 1-4 after a single intravenous infusion of eptinezumab.

Individuals with migraine desire rapid preventive treatment for migraines. Eptinezumab is an anti-CGRP monoclonal antibody that selectively inhibits the CGRP ligand, with 100% bioavailability following intravenous infusion. In clinical trials of adults with EM (NCT02559895) or CM (NCT02974153), eptinezumab 100mg and 300mg met the primary efficacy endpoint, which was the change from baseline in mean monthly migraine days [MMDs] over Wks1-12.

Eligible patients with EM (ICHD-II) or CM (ICHD-3β) were randomized to repeat doses of eptinezumab 100mg, 300mg, or placebo (or 30mg in EM trial), administered every 12 wks. The ≥75% migraine RRs over Wks1-4 was a key secondary efficacy endpoint, with ≥50% and 100% migraine RRs over Wks1-4 as other secondary endpoints.

In patients with EM (100mg, n=221; 300mg, n=222; placebo, n=222), mean MMDs at baseline were ~8.6 across groups. In patients with CM (100mg, n=356; 300mg, n=350; placebo, n=366), baseline mean MMDs were ~16.1 across groups. Over Wks1-4, more eptinezumab-treated patients were ≥50% migraine responders (EM: 100mg, 59.3%; 300mg, 56.3%; CM: 100mg, 54.5%; 300mg, 60.6%) compared with placebo (EM: 40.5%; CM: 40.5%). Greater differences vs placebo were observed in ≥75% migraine RRs for both EM (100mg, 30.8%; 300mg, 31.5%; placebo 20.3%) and CM (100mg, 30.9%; 300mg, 36.9%; placebo 15.6%). Over Wks1-4, 14.9% (EM) and 13.4% (CM) of 300mg-treated patients were 100% migraine responders vs placebo (EM: 5.9%; CM: 2.7%); for 100mg-treated patients, 8.6% (EM) and 7.9% (CM) were 100% migraine responders.

Eptinezumab treatment resulted in a rapid onset of preventive benefit, with over half of patients with EM or CM experiencing a meaningful reduction in MMDs within the first month after the first intravenous infusion.