Eptinezumab improved patient-reported outcomes and quality of life in patients with migraine and prior preventive treatment failures

Peter J Goadsby; Piero Barbanti; Giorgio Lambru; Anders Ettrup; Cecilie Laurberg Christoffersen; Mette Krog Josiassen; Ravinder Phul; Bjørn Sperling

doi:10.1111/ene.15670

Eptinezumab improved patient-reported outcomes and quality of life in patients with migraine and prior preventive treatment failures

Eur J Neurol. 2023 Apr;30(4):1089-1098. doi: 10.1111/ene.15670. Epub 2023 Jan 21.

Authors

Peter J Goadsby^{1

2}, Piero Barbanti^{3

4}, Giorgio Lambru^{5

6}, Anders Ettrup⁷, Cecilie Laurberg Christoffersen⁷, Mette Krog Josiassen⁷, Ravinder Phul⁷, Bjørn Sperling⁷

Affiliations

¹ NIHR SLaM Clinical Research Facility, and Headache Group Wolfson CARD, King's College London, London, UK.
² Department of Neurology, University of California, Los Angeles, CA, USA.
³ Headache and Pain Unit, IRCCS San Raffaele, Rome, Italy.
⁴ San Raffaele University, Rome, Italy.
⁵ The Headache Service, Guy's and St Thomas' Hospitals NHS Trust, London, UK.
⁶ Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
⁷ H. Lundbeck A/S, Copenhagen, Denmark.

PMID: 36583633
DOI: 10.1111/ene.15670

Abstract

Background and purpose: In the phase 3b, randomized, double-blind, placebo-controlled DELIVER clinical trial, eptinezumab reduced migraine frequency and headache in adults with two to four prior preventive treatment failures. Here, the effect of eptinezumab on coinciding patient-reported outcomes is reported.

Methods: Adults were randomized to receive eptinezumab 100, 300 mg or placebo intravenously at weeks 12 and 24. The EQ-5D-5L, measuring overall patient health, and the six-item Headache Impact Test were completed every 4 weeks. The Patient Global Impression of Change was completed at weeks 4, 12 and 24. Patient-identified most bothersome symptom and the Migraine-Specific Quality of Life Questionnaire were administered at weeks 12 and 24.

Results: Eptinezumab improved patient-reported outcomes more than placebo, starting at week 4 and at all subsequent time points. By week 12, patients' overall health (EQ-5D-5L visual analog scale score) improved with eptinezumab treatment (difference from placebo in change from baseline: 100 mg, 5.1, 95% confidence interval [CI] 2.2, 8.1, p < 0.001; 300 mg, 7.5, 95% CI 4.5, 10.4, p < 0.0001). At week 12, eptinezumab improved headache-related quality of life (difference from placebo in change from baseline in Headache Impact Test total score: 100 mg, -3.8, 95% CI -5.0, -2.5, p < 0.0001; 300 mg, -5.4, 95% CI -6.7, -4.2, p < 0.0001), including each Migraine-Specific Quality of Life Questionnaire domain (p ≤ 0.0001, all comparisons). Over twice as many patients receiving eptinezumab than placebo reported much or very much improvement on the Patient Global Impression of Change and patient-identified most bothersome symptom.

Conclusion: Patients with two to four prior preventive treatment failures receiving eptinezumab versus placebo reported greater improvements in well-being, quality of life and most bothersome symptoms compared to placebo.

Trial registration: ClinicalTrials.gov identifier: NCT04418765; EudraCT identifier: 2019-004497-25.

Keywords: efficacy; eptinezumab; migraine prevention; prior preventive treatment failure.

Publication types

Randomized Controlled Trial
Clinical Trial, Phase III
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Double-Blind Method
Headache
Humans
Migraine Disorders* / drug therapy
Patient Reported Outcome Measures
Quality of Life*
Treatment Failure
Treatment Outcome

Substances

eptinezumab

Associated data

ClinicalTrials.gov/NCT04418765
EudraCT/2019-004497-25