Quantity changes in acute headache medication use among patients with chronic migraine treated with eptinezumab: subanalysis of the PROMISE-2 study

Abstract

Background: Patients with chronic migraine (CM) treated with eptinezumab in the PROMISE-2 trial achieved greater reductions in migraine and headache frequency, impact, and acute headache medication (AHM) use than did patients who received placebo. This post hoc analysis examines relationships between headache frequency reductions and changes in AHM use in patients in PROMISE-2.

Methods: PROMISE-2 was a double-blind, placebo-controlled trial conducted in adults with CM. Patients were randomized to eptinezumab 100 mg, 300 mg, or placebo, administered intravenously once every 12 weeks for up to two doses. Patients recorded headache/AHM information daily and for each event in an electronic diary; data from all days with daily reports were included. Shifts in headache frequency and AHM use were assessed in the three populations: total CM population, patients with CM and medication-overuse headache (MOH), and patients with CM and MOH who were ≥ 50% responders during treatment (response over weeks 1-24).

Results: A total of 1072 adults with CM received treatment (eptinezumab, n = 706; placebo, n = 366). Mean baseline headache frequency was 20.5 days; mean baseline AHM days was 13.4; 431 patients had MOH, of which 225 (52.2%) experienced ≥50% response over weeks 1-24. Relative to baseline, the proportion of days with both headache and AHM use decreased 25.1% (eptinezumab) versus 17.0% (placebo) in the total population (N = 1072), 29.2% versus 18.4% in the MOH subpopulation (n = 431), and 38.3% versus 31.5% in the CM with MOH population with ≥50% response subgroup (n = 225) during weeks 1-24. The proportion of days with headache and triptan use decreased 9.1% (eptinezumab) versus 5.8% (placebo), 11.8% versus 7.2%, and 14.5% versus 12.6%, respectively. Reductions in other AHM types were smaller.

Conclusions: In this post hoc analysis, eptinezumab use in patients with CM was associated with greater decreases in days with headache with AHM overall and with triptans in particular. The magnitude of effect was greater in the subgroup of CM patients with MOH and ≥ 50% response.

Trial registration: ClinicalTrials.gov Identifier: NCT02974153 . Eptinezumab reduces headache frequency and acute medication use in patients with chronic migraine.

Keywords: Analgesics; Chronic migraine; Eptinezumab; Medication-overuse headache; Serotonin 5-HT1 receptor agonists.

Conflict of interest statement

RPC has been a consultant and/or advisory board member for Alder, Allergan, Amgen, ATI, electroCore, eNeura, Novartis, Teva, and Zosano; served on a speaker’s bureau for Biohaven; as an expert consultant for GLG, Guidepoint Global, Impel, Satsuma, Spherix Global Insights, Teva, Theranica, XOC, and Zosano; and received royalties from Penguin/Avery and Springer.

MM has received grants for research (no personal compensation) from Allergan/AbbVie, electroCore, and Teva; served as a consultant and/or advisory board member for Alder/Lundbeck, Amgen/Novartis, and Theranica; participated in a speaker’s bureau for Amgen/ Novartis and Eli Lilly; and received royalties from Cambridge, Demos Medical, and MedLink.

HD has received honoraria for participation in clinical trials, contribution to advisory boards, or oral presentations over the last 3 years from Allergan, Eli Lilly, Lundbeck, MSD, Novartis, Pfizer, Teva, and Weber & Weber; headache research support from the German Research Council (DFG); and served on editorial boards for Cephalalgia, Lancet Neurology, and Drugs.

AS has received consulting fees from Alder, Amgen, Eli Lilly, eNeura, Impel, Lundbeck, Novartis, and Theranica.

JS has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda, Allergan, Amgen, Avanir, Depomed, electroCore, Eli Lilly, Novartis, Pernix, Promius, Supernus, Teva Pharmaceuticals, and Upsher-Smith; holds stock and/or stock options in Alder/Lundbeck, which sponsored research in which JS was involved as an investigator; and has received research support from Allergan, Amgen, and Eli Lilly.

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

TB and RC were employees of Lundbeck or one of its subsidiary companies at the time of study.

© 2022. The Author(s).

Figures

Fig. 1

Days with AHM use among patients with CM, by headache status (with or without headache); AHM type included for days with headache and AHM use. AHM, acute headache medication; CM, chronic migraine

Fig. 2

Days with AHM use among patients with CM and MOH, by headache status (with or without headache); AHM type included for days with headache and AHM use. AHM, acute headache medication; CM, chronic migraine; MOH, medication-overuse headache

Fig. 3

Days with AHM use among patients with CM and MOH who experienced ≥50% response over weeks 1–24, by headache status (with or without headache); AHM type included for days with headache and AHM use. AHM, acute headache medication; CM, chronic migraine; MOH, medication-overuse headache

Fig. 4

Acute headache medication type on headache days with acute headache medication use at baseline and weeks 1–24 in patients with CM who received eptinezumab and placebo. CM, chronic migraine