OBJECTIVES: To evaluate changes in days of acute headache medication (AHM) use after eptinezumab treatment among patients with chronic migraine (CM) and medication-overuse headache (MOH).

METHODS: PROMISE-2 (NCT02974153) was a double-blind, randomized, placebo-controlled phase 3 study evaluating the safety and efficacy of eptinezumab 100mg and 300mg in adult patients with CM. MOH was prospectively diagnosed. Daily eDiaries captured whether patients experienced a headache, if they used AHM, and what type of AHM was used.

RESULTS: Of 1072 patients in PROMISE-2, 431 (40.2%) were diagnosed with MOH (100mg, n=139; 300mg, n=147; placebo, n=145). Mean days of any AHM use decreased from 16.4 at baseline to 8.8 over weeks 1-12 with eptinezumab 100mg and from 16.7 to 9.9 with eptinezumab 300mg versus from 16.1 to 11.8 with placebo. Over weeks 13-24, mean days of any AHM use were 8.2 (100mg), 8.6 (300mg), and 11.0 (placebo). There were 18,504 and 9,560 study days with medication data during the 28-day screening/baseline period for the eptinezumab (doses combined) and placebo groups, respectively, and 100,390 and 50,632 days during the post-baseline period (Weeks 1-24). The proportion of days with headache and AHM use decreased more in eptinezumab-treated patients from baseline to post-baseline compared to placebo (‒29.1 versus ‒18.4%-points). The proportion reporting no headache and no AHM use increased 33.8%-points and 23.6%-points for eptinezumab and placebo, respectively. The proportion with headache and no AHM use decreased across treatment groups (‒6.1 and ‒7.1%-points for eptinezumab and placebo, respectively). Triptans were the most used AHMs in the eptinezumab (20.1%) and placebo groups (19.3%) at baseline, but triptan use decreased more with eptinezumab versus placebo (‒11.8 vs ‒7.2%-points).

CONCLUSIONS: Eptinezumab was associated with greater declines in headache frequency and days of AHM use versus placebo in patients with CM and MOH.