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
To evaluate changes in days of acute headache medication (AHM) use among patients with medication-overuse headache (MOH) from the PROMISE-2 trial.
Eptinezumab is a humanized monoclonal antibody targeting calcitonin gene-related peptide and approved for migraine prevention. 
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.
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.
Eptinezumab was associated with greater declines in headache frequency and days of AHM use versus placebo in patients with CM and MOH.