Changes in Acute Headache Medication Use Among Patients With Chronic Migraine and Medication-Overuse Headache: An Exploratory Analysis of PROMISE-2

Abstract text (incl. figure legends and references)

OBJECTIVE: This post hoc analysis evaluated changes in days of acute headache medication (AHM) use among patients with medication-overuse headache (MOH) from the PROMISE-2 trial.

METHODS: PROMISE-2 (NCT02974153) was a double-blind, randomized, placebo-controlled phase 3 study evaluating safety and efficacy of eptinezumab (100 or 300 mg) in adults with chronic migraine (CM). In eDiaries, patients indicated daily whether they experienced a headache, used AHM, and type of AHM used.

RESULTS: Of the 1072 patients with CM in PROMISE-2, 431 (40.2%) were formally diagnosed with MOH. The 28-day screening/baseline period comprised 18,504 (eptinezumab) and 9,560 (placebo) study days with medication data; Weeks 1-24 comprised 100,390 and 50,632 days, respectively. The proportion of headache days and AHM use decreased ‒29.1%-points (eptinezumab) vs ‒18.4%-points (placebo), and the proportion reporting no headache or AHM use increased 33.8%-points vs 23.6%-points, respectively. The proportion with headache and no AHM use decreased 6.1%-points and ‒7.1%-points for eptinezumab and placebo, respectively. Triptans were the most used AHMs at baseline (eptinezumab, 20.1%; placebo 19.3%), but triptan use decreased more with eptinezumab vs placebo (‒11.8 vs ‒7.2%-points).

CONCLUSIONS: Eptinezumab was associated with greater declines in headache frequency and days of AHM use vs placebo in patients with a dual diagnosis of CM and MOH, especially the subgroup of patients experiencing ≥50% response.