Early response to eptinezumab indicates high likelihood of continued response in patients with chronic migraine

The Journal of Headache and Pain

Dawn C. Buse¹  Larry Charleston²  Thomas Brevig³  Roger Cady⁴  Joe Hirman⁵  Paul K. Winner⁶ 

[1] Albert Einstein College of Medicine, Bronx, NY, USA;Vector Psychometric Group, LLC, Chapel Hill, NC, USA;Department of Neurology and Ophthalmology, Michigan State University College of Human Medicine, East Lansing, MI, USA;H. Lundbeck A/S, Copenhagen, Denmark;Lundbeck LLC, Deerfield, IL, USA;Pacific Northwest Statistical Consulting, Inc., Woodinville, WA, USA;Palm Beach Headache Center, West Palm Beach, FL, USA;

关键词: Eptinezumab;    Chronic migraine;    Migraine prevention;    Clinical response;   

DOI  :  10.1186/s10194-022-01387-y

来源: Springer

【 摘 要 】

BackgroundA clinical ability to describe the response trajectory of patients receiving preventive migraine treatment could expedite and improve therapeutic management decisions. This post hoc analysis of the PROMISE-2 study evaluated the consistency and predictive power of Month 1 treatment response on later response in patients with chronic migraine.MethodsPROMISE-2 was a double-blind, placebo-controlled trial that randomized adults with chronic migraine to eptinezumab 100 mg, 300 mg, or placebo administered IV every 12 weeks for up to 24 weeks (2 infusions over 6 study months). Migraine responder rates (MRRs) were calculated from monthly migraine days over 4-week intervals compared with baseline. Patients were grouped by MRR during Month 1 (< 25%, 25–< 50%, 50–< 75%, and ≥ 75%), with the number of subsequent study months (Months 2–6) with ≥50% and ≥ 75% MRR calculated in each subgroup. A similar analysis was conducted using Patient Global Impression of Change (PGIC) rating to define Month 1 subgroups (very much improved, much improved, minimally improved, and no change/worse) and rates of very much improved or much improved PGIC during Months 2–6.ResultsIn the eptinezumab 100 mg, 300 mg, and placebo groups, respectively, 194/356 (54.5%), 212/350 (60.6%), and 132/366 (36.1%) patients were ≥ 50% migraine responders during Month 1. More eptinezumab-treated patients were ≥ 75% migraine responders (100 mg, 110/356 [30.9%]; 300 mg, 129/350 [36.9%]; placebo, 57/366 [15.6%]) and more placebo-treated patients were < 25% migraine responders (eptinezumab 100 mg, 103/356 [28.9%]; 300 mg, 80/350 [22.9%]; placebo, 153/366 [41.8%]). Among patients who achieved ≥75% migraine response in Month 1, more than one-third attained ≥75% migraine response for all 5 subsequent study months and more than two-thirds achieved ≥75% migraine response for ≥3 months. More than two-thirds of those in the very much improved (PGIC) subgroup at Month 1 were much or very much improved for all 5 subsequent months.ConclusionsIn this post hoc analysis of data from PROMISE-2, more eptinezumab-treated than placebo-treated patients were early (Month 1) responders, and most early responders went on to achieve a high level of response for at least half of the 24-week treatment period. Potential for later response in early non-responders was also observed.Trial registrationClinicalTrials.gov identifier: NCT02974153; registered November 23, 2016.

【 授权许可】

CC BY