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Effects of eptinezumab on self-reported work productivity in adults with migraine and prior preventive treatment failure in the randomized, double-blind, placebo-controlled DELIVER study

BACKGROUND: The multinational phase 3b DELIVER trial was designed to evaluate the efficacy and safety of eptinezumab for migraine prevention in patients with prior preventive treatment failures across 17 countries. In the placebo-controlled portion, eptinezumab relative to placebo demonstrated great...

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Autores principales: Barbanti, Piero, Goadsby, Peter J., Lambru, Giorgio, Ettrup, Anders, Christoffersen, Cecilie Laurberg, Josiassen, Mette Krog, Phul, Ravinder, Sperling, Bjørn
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Milan 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9716694/
https://www.ncbi.nlm.nih.gov/pubmed/36460983
http://dx.doi.org/10.1186/s10194-022-01521-w
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author Barbanti, Piero
Goadsby, Peter J.
Lambru, Giorgio
Ettrup, Anders
Christoffersen, Cecilie Laurberg
Josiassen, Mette Krog
Phul, Ravinder
Sperling, Bjørn
author_facet Barbanti, Piero
Goadsby, Peter J.
Lambru, Giorgio
Ettrup, Anders
Christoffersen, Cecilie Laurberg
Josiassen, Mette Krog
Phul, Ravinder
Sperling, Bjørn
author_sort Barbanti, Piero
collection PubMed
description BACKGROUND: The multinational phase 3b DELIVER trial was designed to evaluate the efficacy and safety of eptinezumab for migraine prevention in patients with prior preventive treatment failures across 17 countries. In the placebo-controlled portion, eptinezumab relative to placebo demonstrated greater reductions in migraine and headache frequency, migraine and headache severity, and acute medication use. The objective of this report is to describe the effects of eptinezumab on self-reported work productivity in the placebo-controlled portion of DELIVER. METHODS: Adults 18–75 years of age with migraine and documented evidence of 2 to 4 prior preventive treatment failures in the past 10 years were randomized to receive eptinezumab 100 mg, 300 mg, or placebo intravenously (IV) every 12 weeks. The Work Productivity and Activity Impairment questionnaire specific to migraine (WPAI:M), which comprises 6 items (4 of which are completed by currently employed patients only), was administered every 4 weeks. Changes from baseline in subscores (absenteeism, presenteeism, work productivity loss, and activity impairment) were calculated based on item responses. A mixed model for repeated measures was used to analyze changes from baseline in WPAI:M subscores. RESULTS: A total of 890 adults (mean age, 43.8 years) were included in the full analysis set (eptinezumab 100 mg, n = 299; eptinezumab 300 mg, n = 293; placebo, n = 298). Mean WPAI:M subscores at baseline indicated a negative impact of migraine attacks on work productivity and ability to complete normal daily activities. Eptinezumab improved WPAI:M subscores more than placebo at all assessment points throughout the study. Mean changes from baseline in self-reported work productivity loss were −19.5, −24.0, and −9.7 at Week 12; and −22.6, −20.2, and −7.2 at Week 24 (all P < 0.001 vs placebo) for eptinezumab 100 mg, eptinezumab 300 mg, and placebo, respectively. Mean changes from baseline in activity impairment were −21.3, −23.8, and −11.2 at Week 12; and −24.7, −22.6, and −10.1 at Week 24 (all P < 0.0001 vs placebo). Similarly, mean improvements in absenteeism and presenteeism were greater in the eptinezumab groups than in the groups receiving placebo at all timepoints (P < 0.05). CONCLUSION: In adults with migraine and prior preventive treatment failure, eptinezumab 100 mg and 300 mg IV every 12 weeks improved absenteeism, presenteeism, work productivity loss, and activity impairment more than placebo. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT04418765); EudraCT (Identifier: 2019–004497-25) (https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004497-25/PL). GRAPHICAL ABSTRACT: Eptinezumab improves self-reported work productivity in patients with migraine and prior preventive treatment failures. [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s10194-022-01521-w.
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spelling pubmed-97166942022-12-03 Effects of eptinezumab on self-reported work productivity in adults with migraine and prior preventive treatment failure in the randomized, double-blind, placebo-controlled DELIVER study Barbanti, Piero Goadsby, Peter J. Lambru, Giorgio Ettrup, Anders Christoffersen, Cecilie Laurberg Josiassen, Mette Krog Phul, Ravinder Sperling, Bjørn J Headache Pain Research BACKGROUND: The multinational phase 3b DELIVER trial was designed to evaluate the efficacy and safety of eptinezumab for migraine prevention in patients with prior preventive treatment failures across 17 countries. In the placebo-controlled portion, eptinezumab relative to placebo demonstrated greater reductions in migraine and headache frequency, migraine and headache severity, and acute medication use. The objective of this report is to describe the effects of eptinezumab on self-reported work productivity in the placebo-controlled portion of DELIVER. METHODS: Adults 18–75 years of age with migraine and documented evidence of 2 to 4 prior preventive treatment failures in the past 10 years were randomized to receive eptinezumab 100 mg, 300 mg, or placebo intravenously (IV) every 12 weeks. The Work Productivity and Activity Impairment questionnaire specific to migraine (WPAI:M), which comprises 6 items (4 of which are completed by currently employed patients only), was administered every 4 weeks. Changes from baseline in subscores (absenteeism, presenteeism, work productivity loss, and activity impairment) were calculated based on item responses. A mixed model for repeated measures was used to analyze changes from baseline in WPAI:M subscores. RESULTS: A total of 890 adults (mean age, 43.8 years) were included in the full analysis set (eptinezumab 100 mg, n = 299; eptinezumab 300 mg, n = 293; placebo, n = 298). Mean WPAI:M subscores at baseline indicated a negative impact of migraine attacks on work productivity and ability to complete normal daily activities. Eptinezumab improved WPAI:M subscores more than placebo at all assessment points throughout the study. Mean changes from baseline in self-reported work productivity loss were −19.5, −24.0, and −9.7 at Week 12; and −22.6, −20.2, and −7.2 at Week 24 (all P < 0.001 vs placebo) for eptinezumab 100 mg, eptinezumab 300 mg, and placebo, respectively. Mean changes from baseline in activity impairment were −21.3, −23.8, and −11.2 at Week 12; and −24.7, −22.6, and −10.1 at Week 24 (all P < 0.0001 vs placebo). Similarly, mean improvements in absenteeism and presenteeism were greater in the eptinezumab groups than in the groups receiving placebo at all timepoints (P < 0.05). CONCLUSION: In adults with migraine and prior preventive treatment failure, eptinezumab 100 mg and 300 mg IV every 12 weeks improved absenteeism, presenteeism, work productivity loss, and activity impairment more than placebo. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT04418765); EudraCT (Identifier: 2019–004497-25) (https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004497-25/PL). GRAPHICAL ABSTRACT: Eptinezumab improves self-reported work productivity in patients with migraine and prior preventive treatment failures. [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s10194-022-01521-w. Springer Milan 2022-12-02 /pmc/articles/PMC9716694/ /pubmed/36460983 http://dx.doi.org/10.1186/s10194-022-01521-w Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Barbanti, Piero
Goadsby, Peter J.
Lambru, Giorgio
Ettrup, Anders
Christoffersen, Cecilie Laurberg
Josiassen, Mette Krog
Phul, Ravinder
Sperling, Bjørn
Effects of eptinezumab on self-reported work productivity in adults with migraine and prior preventive treatment failure in the randomized, double-blind, placebo-controlled DELIVER study
title Effects of eptinezumab on self-reported work productivity in adults with migraine and prior preventive treatment failure in the randomized, double-blind, placebo-controlled DELIVER study
title_full Effects of eptinezumab on self-reported work productivity in adults with migraine and prior preventive treatment failure in the randomized, double-blind, placebo-controlled DELIVER study
title_fullStr Effects of eptinezumab on self-reported work productivity in adults with migraine and prior preventive treatment failure in the randomized, double-blind, placebo-controlled DELIVER study
title_full_unstemmed Effects of eptinezumab on self-reported work productivity in adults with migraine and prior preventive treatment failure in the randomized, double-blind, placebo-controlled DELIVER study
title_short Effects of eptinezumab on self-reported work productivity in adults with migraine and prior preventive treatment failure in the randomized, double-blind, placebo-controlled DELIVER study
title_sort effects of eptinezumab on self-reported work productivity in adults with migraine and prior preventive treatment failure in the randomized, double-blind, placebo-controlled deliver study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9716694/
https://www.ncbi.nlm.nih.gov/pubmed/36460983
http://dx.doi.org/10.1186/s10194-022-01521-w
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