Abstract Details

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

Topic Headache

Presentation(s) P16 - Poster Session 16 (8:00 AM-9:00 AM)

Poster/Presentation
Number 15-002

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.

Authors/Disclosures
Roger Cady, MD (RK Consulting, LLC) PRESENTER	Dr. Cady has received personal compensation for serving as an employee of Lundbeck. Dr. Cady has stock in Alder Biopharmaceutical.
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.
Michael J. Marmura, MD, FAAN (Thomas Jefferson University)	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 AbbVie. The institution of Dr. Marmura has received research support from Teva. The institution of Dr. Marmura has received research support from AbbVie. The institution of Dr. Marmura has received research support from Axsome. The institution of Dr. Marmura has received research support from Pfizer. 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.
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 $10,000-$49,999 for serving as a Consultant for Lundbeck. 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 $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 Pfizer. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Salvia. Dr. Starling has received personal compensation in the range of $0-$499 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 Amneal. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for eNeura. Dr. Starling has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Woodberry Associates .
Jack D. Schim, MD, FAAN	Dr. Schim has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Aeon, Abbvie, Amgen, Biohaven, electroCore, Impel, Lilly, Lundbeck, Novartis, Promius, Revance, Teva, Upsher-Smith. Dr. Schim has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan, Amgen, Biohaven, electroCore, Lilly, Lundbeck, Novartis, Promius, Teva, Theranica, Upsher-Smith.
	No disclosure on file
	No disclosure on file

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