Changes in Acute Headache Medication Use Among Patients With Chronic Migraine and Medication-Overuse Headache: An Exploratory Analysis of PROMISE-2
Robert Cowan1, Michael J. Marmura2, Hans-Christoph Diener3, Amaal J. Starling4, Jack Schim5, Joe Hirman6, Thomas Brevig7, Roger Cady8
1Stanford Health Care, 2Jefferson Headache Center, 3University Duisburg-Essen, Institute for Medical Informatics, Biometry and Epidemiology, 4Mayo Clinic, 5The Neurology Center of Southern California, 6Pacific Northwest Statistical Consulting, Inc., 7H. Lundbeck A/S, 8Lundbeck LLC, Deerfield, IL
Objective:
To evaluate changes in days of acute headache medication (AHM) use among patients with medication-overuse headache (MOH) from the PROMISE-2 trial.
Background:
Eptinezumab is a humanized monoclonal antibody targeting calcitonin gene-related peptide and approved for migraine prevention. 
Design/Methods:
PROMISE-2 (NCT02974153) was a double-blind, randomized, placebo-controlled phase 3 study evaluating the safety and efficacy of eptinezumab (100 mg or 300 mg) in adult patients with chronic migraine (CM). In an eDiary, patients indicated daily whether they experienced a headache, if they used AHM, and what type of AHM was used.
Results:
Of the 1,072 patients with CM in PROMISE-2, 431 (40.2%) were diagnosed with MOH (eptinezumab 100 mg, n=139; 300 mg, n=147; placebo, n=145). Across patients with MOH, there were 18,504 and 9,560 study days with medication data during the 28-day screening/baseline period for the eptinezumab 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). Declines in use of other AHMs were slightly larger in eptinezumab-treated patients versus placebo patients (combination analgesics, ‒4.5 vs ‒2.3%-points; multiple agents, ‒6.6 vs ‒2.2%-points) except for simple analgesics, opioids, and ergots, which were similar between groups.
Conclusions:
Eptinezumab was associated with greater declines in headache frequency and days of AHM use versus placebo in patients with CM and MOH.