Program

In-person AND virtual! – We are pioneering a new conference format that will connect in-person and virtual audiences to create a unique experience. Matching the innovation that comes through our members’ work, ISPOR is pushing the boundaries of innovation to design an event that works in today’s quickly changing environment. 

In-person registration included the full virtual experience, and virtual-only attendees will be able to tune into live in-person sessions and/or watch captured in-person sessions on-demand in addition to having a variety of virtual-only sessions to attend.

Reductions in Acute Headache Medication Use after Eptinezumab Treatment in Patients with Chronic Migraines and Medication-Overuse Headache: Exploratory Analysis of PROMISE-2

Speaker(s)

Cowan RP1, Marmura MJ2, Diener HC3, Starling AJ4, Schim J5, Hirman J6, Brevig T7, Cady R8
1Stanford Health Care, Palo Alto, CA, USA, 2Jefferson Headache Center, Philadelphia, PA, USA, 3University Duisburg, Essen, Germany, 4Mayo Clinic Arizona, Scottdsale, AZ, USA, 5The Neurology Center of Southern California, Carlsbad, CA, USA, 6Pacific Northwest Statistical Consulting, Inc., Woodinville, WA, USA, 7H. Lundbeck A/S, Valby, Denmark, 8Lundbeck LLC, Ozark, MO, USA

Presentation Documents

OBJECTIVES: To evaluate changes in days of acute headache medication (AHM) use after eptinezumab treatment among patients with chronic migraine (CM) and medication-overuse headache (MOH).

METHODS: PROMISE-2 (NCT02974153) was a double-blind, randomized, placebo-controlled phase 3 study evaluating the safety and efficacy of eptinezumab 100mg and 300mg in adult patients with CM. MOH was prospectively diagnosed. Daily eDiaries captured whether patients experienced a headache, if they used AHM, and what type of AHM was used.

RESULTS: Of 1072 patients in PROMISE-2, 431 (40.2%) were diagnosed with MOH (100mg, n=139; 300mg, n=147; placebo, n=145). Mean days of any AHM use decreased from 16.4 at baseline to 8.8 over weeks 1-12 with eptinezumab 100mg and from 16.7 to 9.9 with eptinezumab 300mg versus from 16.1 to 11.8 with placebo. Over weeks 13-24, mean days of any AHM use were 8.2 (100mg), 8.6 (300mg), and 11.0 (placebo). There were 18,504 and 9,560 study days with medication data during the 28-day screening/baseline period for the eptinezumab (doses combined) 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).

CONCLUSIONS: Eptinezumab was associated with greater declines in headache frequency and days of AHM use versus placebo in patients with CM and MOH.

Code

CO157

Topic

Clinical Outcomes, Patient-Centered Research

Topic Subcategory

Clinical Outcomes Assessment, Patient-reported Outcomes & Quality of Life Outcomes

Disease

No Additional Disease & Conditions/Specialized Treatment Areas