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

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.

Keywords: Chronic migraine; Clinical response; Eptinezumab; Migraine prevention.

Conflict of interest statement

DCB: Received grant support from Amgen, the National Headache Foundation and the FDA; received consulting support from Allergan/Abbvie, Amgen, Lilly, Lundbeck, and Teva; and serves on the editorial board of Current Pain and Headache Reports.

PKW: Receives consulting fees from Abbvie, Aeon, Amgen, Axsome, Biohaven, GlaxoSmithKline, Impel, Lilly, Lundbeck, Nesos, Satsuma, Theranica, and Teva; serves on speaker bureaus for Abbvie, Amgen, Biohaven, Lilly, Lundbeck, Novartis, Teva; and receives research support from AbbVie, Biohaven, Lilly, Satsuma, and Zosano.

LCIV: Receives personal compensation for serving as a consultant for Alder/Lundbeck, Allergan/AbbVie, Biohaven, Satsuma, and Teva and for serving as an Expert Witness for Vaccine Injury Compensation Program. He is on the advisory panel of Ctrl M Health (stock). In addition, he is a non-compensated Associate Editor with Headache and has a non-compensated relationship as a Board Member at Large with Alliance for Headache Disorders Advocacy.

JH: Employee of Pacific Northwest Statistical Consulting, Inc., a contracted service provider of biostatistical resources for H. Lundbeck A/S.

RC: Employee of Lundbeck or one of its subsidiary companies at the time of study and manuscript development.

TB: Employee of H. Lundbeck A/S or one of its subsidiary companies and has equity in H. Lundbeck A/S.

© 2022. The Author(s).

Figures

Fig. 1

Monthly migraine respondera rates: (A) ≥50% and (B) ≥75%. aMigraine response was defined as a reduction in monthly migraine days. MRR, migraine responder rate

Fig. 2

Monthly response according to Month 1 migraine responsea category: (A) ≥75%, (B) 50–< 75%, (C) 25–< 50%, (D) < 25%. aMigraine response was defined as a percentage reduction in monthly migraine days. MRR, migraine responder rate

Fig. 3

Frequency of monthly ≥75% migraine response according to Month 1 migraine responsea category: (A) ≥75%, (B) 50–< 75%, (C) 25–< 50%, (D) < 25%.aMigraine response was defined as a reduction in monthly migraine days. MRR, migraine responder rate

Fig. 4

Frequency of monthly ≥50% migraine response according to Month 1 migraine responsea: (A) ≥75%, (B) 50–< 75%, (C) 25–< 50%, (D) < 25%. aMigraine response was defined as a percentage reduction in monthly migraine days. MRR, migraine responder rate

Fig. 5

Frequency of PGIC responsea according to PGIC rating at Month 1: (A) very much improved, (B) much improved, (C) minimally improved, (D) no improvement. aPGIC response defined as rating of “much improved” or “very much improved.” bIncludes patients reporting “no change,” “minimally worse,” “much worse,” and “very much worse.” Analysis conducted in patients with PGIC data at all time points. PGIC, Patient Global Impression of Change