Abstract Details

Title Preventive Treatment With Eptinezumab in Patients With a Dual Diagnosis of Chronic Migraine and Medication-Overuse Headache: Subgroup Analysis of PROMISE-2

Topic Headache

Presentation(s) S47 - Advances in Migraine Therapeutics (2:00 PM-2:12 PM)

Poster/Presentation
Number 006

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.

Objective To analyze the migraine-preventive efficacy of eptinezumab in patients with a dual diagnosis of chronic migraine (CM) and medication-overuse headache (MOH).

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.

Authors/Disclosures
Michael J. Marmura, MD, FAAN (Thomas Jefferson University) PRESENTER	Dr. Marmura has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Marmura has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome. Dr. Marmura has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Marmura has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Marmura has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Marmura has stock in Curelator. The institution of Dr. Marmura has received research support from Teva. The institution of Dr. Marmura has received research support from AbbVie. Dr. Marmura has received publishing royalties from a publication relating to health care. Dr. Marmura has received publishing royalties from a publication relating to health care. Dr. Marmura has received publishing royalties from a publication relating to health care.
H. C. Diener, MD, FAAN (University Duisburg-Essen)	Dr. Diener has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Diener has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. Dr. Diener has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. Dr. Diener has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer. Dr. Diener has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Thieme. The institution of Dr. Diener has received research support from German Research Council.
Robert Cowan, MD, FAAN (Stanford Neurosciences Health Center)	Dr. Cowan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Cowan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. Dr. Cowan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Cowan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Cowan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Cowan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for lundbeck. Dr. Cowan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for biohavenn. Dr. Cowan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbviie. Dr. Cowan has stock in Percept. Dr. Cowan has received intellectual property interests from a discovery or technology relating to health care. Dr. Cowan has received intellectual property interests from a discovery or technology relating to health care. Dr. Cowan has received publishing royalties from a publication relating to health care.
Amaal J. Starling, MD, FAAN (Mayo Clinic)	Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome Therapeutics. Dr. Starling has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Starling has received personal compensation in the range of $0-$499 for serving as a Consultant for Med-IQ. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medscape. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Everyday Health. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for WebMD. Dr. Starling has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Miller Medical. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for eNeura.
	No disclosure on file
	No disclosure on file
Roger Cady, MD (RK Consulting, LLC)	Dr. Cady has received personal compensation for serving as an employee of Lundbeck. Dr. Cady has stock in Alder Biopharmaceutical.