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.

Patients With Chronic Migraine Improving to Fewer than 4 Monthly Headache Days Is an Effective Treatment Goal for Chronic Migraine

Speaker(s)

Kaniecki R1, Friedman DI2, Hirman J3, Cady R4
1Department of Neurology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA, 2Departments of Neurology and Neurotherapeutics and Ophthalmology,University of Texas Southwestern Medical Center, Dallas, TX, USA, 3Pacific Northwest Statistical Consulting, Inc., Woodinville, WA, USA, 4Lundbeck LLC, Ozark, MO, USA

Presentation Documents

OBJECTIVES: Current therapeutic goals for migraine treatment include ≥50% or ≥75% reduction in monthly migraine days (ie, responder rates). Monthly headache days (MHDs) may be a more straightforward assessment tool for the treatment of patients with CM. The objective of this analysis was to determine a threshold number of MHDs that clinicians can use as a therapeutic goal for patients with chronic migraine (CM).

METHODS: In PROMISE-2 (NCT02974153), a randomized, double-blinded, placebo-controlled phase 3 study evaluating eptinezumab for the preventive treatment of CM, patients (N=1072) received eptinezumab 100mg, 300mg, or placebo on Day 0 and Week 12; all arms were pooled for analysis. All available data points for 6-item Headache Impact Test (HIT-6) total score, Patient Global Impression of Change (PGIC), and days of acute medication use were combined for Weeks 4, 12, 16, and 24 and analyzed by number of MHDs (≤4, 5-9, 10-14, ≥15) during the 4 weeks preceding the respective assessment. Patient-months correspond to 4-week study intervals.

RESULTS: Of patient-months with ≤4 MHDs, 67.6% (561/830) were associated with “little to none” or “some” HIT-6 impairment, vs 47.6% (447/940), 29.9% (240/803), and 13.9% (210/1507) of patient-months with 5-9, 10-14, and ≥15 MHDs, respectively. Of patient-months with ≤4 MHDs, 85.8% (1079/1258) were associated with “very much” or “much” improved PGIC, vs 69.9% (989/1415), 49.6% (607/1224), and 21.5% (480/2229) of patient-months with 5-9, 10-14, and ≥15 MHDs, respectively. Patient-months with ≤4, 5-9, 10-14, and ≥15 MHDs used acute medication for ≥10 days on 1.9% (21/1111), 5.0% (63/1267), 49.6% (670/1351), and 74.1% (1232/1662) of patient-months, respectively.

CONCLUSIONS: In this post hoc analysis, patients improving to ≤4 MHDs achieved superior outcomes with the least acute medication use, suggesting that 4 MHDs may be a useful treatment goal for patients with CM.

Code

CO120

Topic

Clinical Outcomes, Patient-Centered Research

Topic Subcategory

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

Disease

Neurological Disorders, No Additional Disease & Conditions/Specialized Treatment Areas