Reduction in migraine-associated burden after eptinezumab treatment in patients with chronic migraine

Abstract

Objective: To examine changes in the occurrence, severity, and symptoms of headache episodes in patients with chronic migraine following eptinezumab treatment.

Methods: PROMISE-2 was a double-blind, placebo-controlled, parallel-group trial that randomized adults with chronic migraine to eptinezumab 100 mg, 300 mg, or placebo IV every 12 weeks for up to 24 weeks (2 infusions). Headache episodes (migraine and non-migraine) and their characteristics were reported in daily electronic diaries during the 28-day baseline and throughout the 24-week treatment period.

Results: A total of 1072 patients were included in this post hoc analysis. Mean monthly headache days decreased by 8.9 (100 mg) and 9.7 (300 mg) compared to a 7.3 decrease in placebo over the first 4-week interval post initial dose and reductions were maintained throughout the 24-week treatment period. Mean monthly headache episodes also decreased by 8.4 (100 mg) and 9.0 (300 mg) compared to a decrease of 7.1 with placebo. The proportion of headache episodes that were migraine attacks decreased by 11.2% (100 mg), 12.4% (300 mg), and 3.9% (placebo), and among remaining headaches decreases in severe pain, nausea, phonophobia, photophobia, and physical activity limitations were numerically greater than placebo.

Conclusions: Patients with chronic migraine treated with eptinezumab decreased the monthly severity and frequency of headache days and episodes more than placebo. Beyond decreased headache frequency, patients treated with eptinezumab reported a reduction in the percent of remaining headache episodes that were migraine attacks, as well as a decrease in burdensome symptoms of headache episodes, indicating additional decreased headache severity after eptinezumab treatment.Trial registration: ClinicalTrials.gov Identifier: NCT02974153; registered November 23, 2016.

Keywords: Eptinezumab; chronic migraine; migraine burden.

Conflict of interest statement

Declaration of conflicting interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article:

PM has received personal fees and research support from AbbVie, Amgen/Novartis, Biohaven, Eli Lilly, Lundbeck, and Teva; consulting fees from Aeon; Speakers Bureau fees from AbbVie, Biohaven, Eli Lilly, Lundbeck, and Teva; and has received stock or an ownership interest from Precept.

DK has received personal compensation for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen, Biohaven, Eli Lilly, Lundbeck, and Novartis; and Speakers Bureau fees from Allergan, Amgen, Biohaven, Eli Lilly, Lundbeck, and Teva.

RC was an employee of Lundbeck or one of its subsidiary companies at the time of study and manuscript development.

AE is an employee of H Lundbeck A/S.

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

Figures

Figure 1.

Mean monthly headache days (MHDs), by 4-week interval. *P < 0.05, **P < 0.01, ***P < 0.001 vs placebo (color-coded by dose).

Figure 2.

Mean change from baseline in monthly headache episodes (MHEs), by 4-week interval. *P < 0.05, **P < 0.01, ***P < 0.001 vs placebo (color-coded by dose).

Figure 3.

Average headache episode characteristics of patients in PROMISE-2: (a) at baseline and (b) mean change from baseline over Weeks 1–24.