Intravenous eptinezumab may prevent migraine for 3 months confirms phase 3 trial
USA: Intravenous eptinezumab, an anti‐CGRP (calcitonin gene-related peptide) monoclonal antibody, showed efficacy for the prevention of chronic migraine headache for 3 months in a dose-ranging, phase 3 trial.
The study was published in the journal Headache and presented at the annual meeting of the American Headache Society.
Migraine is a chronic neurologic disorder that affects about 12 to 14% of people worldwide, It involves periodic attacks of head pain along with symptoms that may include nausea as well as sensitivity to light and sound. More than three-quarters of migraine sufferers experience at least one migraine attack per month, and more than half are severely impaired during their attacks.
For the study, patients with episodic migraine (PROMISE‐1) or chronic migraine (PROMISE‐2) were randomized to receive repeated doses of eptinezumab 100mg, 300mg, or placebo (or 30mg in EM trial). The doses were administered intravenously every 12 weeks for up to 4 (PROMISE‐1) or 2 (PROMISE‐2) infusions.
The primary endpoint in both studies was the change from baseline in MMDs (captured via daily eDiary) over Weeks 1‐12 (Months 1‐3), with headache days captured as a secondary endpoint in the daily eDiary.
A migraine day was defined as any day with a headache that met the International Classification of Headache Disorders criteria for migraine; a headache day was defined as any day with a headache, including those with migraine.
In PROMISE‐1 (100mg, n=221; 300mg, n=222; placebo, n=222), mean MMDs and MHDs at baseline were ~8.6 and ~10.0, respectively, across treatment groups.
Findings for PROMISE-1 trial
- Over the first infusion (Months 1‐3), the mean changes from baseline in MMDs were ‐3.9 (100mg), ‐4.3 (300mg), and ‐3.1 (placebo) and in MHDs were ‐4.0 (100mg), ‐4.5 (300mg), and ‐3.3 (placebo).
- Over the second infusion (Months 4‐6), the mean changes from baseline in MMDs were ‐4.6 (100mg), ‐4.8 (300mg), and ‐3.6 (placebo) and in MHDs were ‐5.2 (100mg), ‐5.3 (300mg), and ‐4.2 (placebo).
In PROMISE‐2 (100mg, n=356; 300mg, n=350; placebo, n=366), mean MMDs and MHDs at baseline were ~16.1 and ~20.4, respectively, across treatment groups.
Findings for PROMISE-2 trial
- Over the first infusion (Months 1‐3), the mean changes from baseline in MMDs were ‐7.8 (100mg), ‐8.3 (300mg), and ‐5.8 (placebo) and in MHDs were ‐8.2 (100mg), ‐8.8 (300mg), and ‐6.4 (placebo).
- Over the second infusion (Months 4‐6), the mean changes from baseline in MMDs were ‐8.3 (100mg), ‐9.0 (300mg), and ‐6.3 (placebo) and in MHDs were ‐9.5 (100mg), ‐10.5 (300mg), and ‐8.0 (placebo).
"In both PROMISE‐1 and PROMISE‐2, the mean change from baseline in MMDs and MHDs increased through the second infusion, demonstrating an increase in the efficacy with subsequent infusion. With the second infusion, the changes in MHDs paralleled the changes in MMDs," concluded the authors.