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The Journal of Headache and Pain

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Open Access 01-12-2022 | Migraine | Research article

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

Authors: Dawn C. Buse, Paul K. Winner, Larry Charleston IV, Joe Hirman, Roger Cady, Thomas Brevig

Published in: The Journal of Headache and Pain | Issue 1/2022

Abstract

Background

A 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.

Methods

PROMISE-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.

Results

In 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.

Conclusions

In 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 registration

ClinicalTrials.gov identifier: NCT02974153; registered November 23, 2016.

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Title: Early response to eptinezumab indicates high likelihood of continued response in patients with chronic migraine
Authors: Dawn C. Buse
Paul K. Winner
Larry Charleston IV
Joe Hirman
Roger Cady
Thomas Brevig
Publication date: 01-12-2022
Publisher: Springer Milan
Keyword: Migraine
Published in: The Journal of Headache and Pain / Issue 1/2022
Print ISSN: 1129-2369
Electronic ISSN: 1129-2377
DOI: https://doi.org/10.1186/s10194-022-01387-y

ACC 2024 Congress

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusions

Trial registration

ACC 2024 Congress

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trial registration

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