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Continued long-term mepolizumab in severe eosinophilic asthma protects from asthma worsening versus stopping mepolizumab: COMET trial

Elisabeth H.D. Bel, Wendy C Moore, Oliver Kornmann, Claude Poirier, Nirihiro Kaneko, Steven G Smith, Neil Martin, Martyn J Gilson, Robert G Price, Eric S Bradford, Marc Humbert
European Respiratory Journal 2020 56: 5280; DOI: 10.1183/13993003.congress-2020.5280
Elisabeth H.D. Bel
1Department of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands
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  • For correspondence: e.h.bel@amsterdamumc.nl
Wendy C Moore
2Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, United States of America
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Oliver Kornmann
3IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany
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Claude Poirier
4Département de médecine, Service de pneumologie, Centre Hospitalier de l'Université de Montréal (CHUM), 1051 Sanguinet, Montreal, QC, Canada
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Nirihiro Kaneko
5Department of Pulmonary Medicine, Kameda Medical Center, Kamogawa, Japan
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Steven G Smith
6Respiratory Medical Franchise, GlaxoSmithKline, Research Triangle Park, NC, United States of America
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Neil Martin
7Global Medical Affairs, GlaxoSmithKline and Institute for Lung Health, University of Leicester, Brentford, Middlesex and Leicester, United Kingdom
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Martyn J Gilson
8Respiratory Research and Development, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom
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Robert G Price
9Biostatistics, GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom
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Eric S Bradford
6Respiratory Medical Franchise, GlaxoSmithKline, Research Triangle Park, NC, United States of America
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Marc Humbert
10Université Paris-Saclay and Assistance Publique- Hôpitaux de Paris, Service de Pneumologie et Soins Intensifs Respiratoires, Hôpital Bicêtre, Le Kremlin-Bicêtre and INSERM U999, Le Kremlin-Bicêtre, Paris, France
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Abstract

Background: The long-term efficacy and safety of mepolizumab in severe eosinophilic asthma (SEA) have been shown.

Aims: To assess the impact of stopping versus continuing long-term mepolizumab on asthma worsening.

Methods: COMET (NCT02555371) was a randomised, double-blind, placebo-controlled study. Patients had completed COLUMBA (NCT01691859) or COSMEX (NCT02135692), had continuous mepolizumab for ≥3 years (mean 46.6 months), and stayed on asthma controller therapy. Randomisation was 1:1 to stop (switch to placebo) or continue subcutaneous mepolizumab 100 mg for 52 weeks. Composite endpoint: time to first asthma worsening (defined in Table). Daily eDiary data were analysed using Kaplan–Meier estimates and a Cox proportional hazards model adjusted for covariates.

Results: Treatment differences for those who stopped versus continued mepolizumab emerged by Week 4 (8 weeks post last open-label mepolizumab dose). For those who stopped mepolizumab, 51.7% reported asthma worsening by Week 52 versus 35.0% who continued mepolizumab (Table), leading to a significantly shorter time to first asthma worsening in those who stopped mepolizumab.

Conclusion: Stopping mepolizumab in patients with SEA led to an increased risk of asthma worsening with a significantly shorter time to first asthma worsening versus those continuing long-term mepolizumab.

Funding: GSK [201810/NCT02555371].

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  • Asthma - management
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Footnotes

Cite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 5280.

This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.

This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).

  • Copyright ©the authors 2020
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Continued long-term mepolizumab in severe eosinophilic asthma protects from asthma worsening versus stopping mepolizumab: COMET trial
Elisabeth H.D. Bel, Wendy C Moore, Oliver Kornmann, Claude Poirier, Nirihiro Kaneko, Steven G Smith, Neil Martin, Martyn J Gilson, Robert G Price, Eric S Bradford, Marc Humbert
European Respiratory Journal Sep 2020, 56 (suppl 64) 5280; DOI: 10.1183/13993003.congress-2020.5280

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Continued long-term mepolizumab in severe eosinophilic asthma protects from asthma worsening versus stopping mepolizumab: COMET trial
Elisabeth H.D. Bel, Wendy C Moore, Oliver Kornmann, Claude Poirier, Nirihiro Kaneko, Steven G Smith, Neil Martin, Martyn J Gilson, Robert G Price, Eric S Bradford, Marc Humbert
European Respiratory Journal Sep 2020, 56 (suppl 64) 5280; DOI: 10.1183/13993003.congress-2020.5280
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