Preventive Treatment With Eptinezumab in Patients With a Dual Diagnosis of Chronic Migraine and Medication-Overuse Headache: Subgroup Analysis of PROMISE-2
Michael J Marmura1, Hans-Christoph Diener2, Robert P Cowan3, Amaal J Starling4, Joe Hirman5, Thomas Brevig6, Roger Cady7
1Jefferson Headache Center, Thomas Jefferson University Hospital, 2Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty of the University of Duisburg-Essen, 3Department of Neurology and Neurological Sciences, Stanford University Headache and Facial Pain Program, 4Mayo Clinic, 5Pacific Northwest Statistical Consulting, Inc., 6H. Lundbeck A/S, 7Lundbeck LLC
Objective:
To analyze the migraine-preventive efficacy of eptinezumab in patients with a dual diagnosis of chronic migraine (CM) and medication-overuse headache (MOH).
Background:
Eptinezumab, a humanized anti-calcitonin gene-related peptide monoclonal antibody, is approved for the preventive treatment of migraine and has demonstrated effectiveness in patients with CM.
Design/Methods:
PROMISE-2 (NCT02974153), a double-blind, placebo-controlled, phase 3 study, randomized adults with CM to intravenous eptinezumab 100mg, 300mg, or placebo at day 0 and week 12 (wk12), for 24 weeks total treatment. Endpoints included changes in monthly migraine days (MMDs), monthly days of acute headache medication (AHM) use, percentage of patients below International Classification of Headache Disorders (ICHD) thresholds for CM and MOH, and assessments of patient-reported outcomes (PROs): 6-item Headache Impact Test (HIT-6), Patient Global Impression of Change (PGIC), and patient-identified most bothersome symptom (PI-MBS).
Results:
At baseline, 431/1072 (40.2%) patients with CM (eptinezumab 100mg [n=139]; 300mg [n=147]; placebo [n=145]) were diagnosed with MOH and averaged 16.7 MMDs. At wk12, mean MMDs decreased 8.4 (100mg) and 8.6 (300mg) from baseline, versus 5.4 placebo (P<0.0001 for both doses). At 24wks, 29.0% of eptinezumab-treated patients were below CM and MOH diagnostic thresholds versus 6.3% with placebo. Total monthly AHM use decreased
9.8 days [BR1] (100mg) and
8.4 days [BR2] (300mg) during wks1-12 vs
5 days [BR3] with placebo. HIT-6 total scores improved 7.0 (100mg) and 7.8 (300mg) vs 4.1 points (placebo) at wk12. At wk12, 58.5% (100mg) and 67.4% (300mg) of patients indicated PGIC was “much” or “very much” improved vs 35.8% placebo. PI-MBS improvement with eptinezumab treatment over placebo was similar to PGIC.
Conclusions:
This post hoc analysis of patients with dual diagnoses of CM and MOH suggests that eptinezumab treatment resulted in greater reductions in MMDs and AHM use compared with placebo and is associated with sustained, clinically meaningful improvements in PROs.