Patients With Chronic Migraine Improving to ≤4 Monthly Headache Days is an Effective Treatment Goal for CM
Robert G. Kaniecki1, Deborah I. Friedman2, Richard Lipton3, Divya Asher4, Joe Hirman5, Roger Cady4,6
1Department of Neurology, University of Pittsburgh School of Medicine, 2Departments of Neurology and Neurotherapeutics and Ophthalmology, University of Texas Southwestern Medical Center, 3Department of Neurology, Albert Einstein College of Medicine, Bronx, New York, 4Lundbeck LLC, Deerfield, IL, 5Pacific Northwest Statistical Consulting, Inc., 6RK Consults, Ozark, MO
Objective:
To determine a threshold number of monthly headache days (MHDs) that clinicians can use as a therapeutic goal for patients with chronic migraine (CM).
Background:
Current therapeutic goals for migraine treatment include ≥50% or ≥75% reduction in monthly migraine days (ie, responder rates). MHDs may be a more straightforward assessment tool for treatment of patients with CM.
Design/Methods:

In PROMISE-2 (NCT02974153), a randomized, double-blind 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. Available data 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 ≥16 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.