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Wechsler ME, Ford LB, Maspero JF, et al. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. Lancet Respir Med. 2021;10(1):11-25doi: 10.1016/S2213-2600(21)00322-2.
Wechsler, M. E., Ford, L. B., Maspero, J. F., Pavord, I. D., Papi, A., Bourdin, A., Watz, H., Castro, M., Nenasheva, N. M., Tohda, Y., Langton, D., Cardona, G., Domingo, C., Park, H. S., Chapman, K. R., Mao, X., Zhang, Y., Khan, A. H., Deniz, Y., Rowe, P. J., Kapoor, U., Khokhar, F. A., Mannent, L. P., Ruddy, M., Laws, E., Amin, N., & Hardin, M. (2022). Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. The Lancet. Respiratory medicine, 10(1), 11-25. https://doi.org/10.1016/S2213-2600(21)00322-2
Wechsler, Michael E, et al. "Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study." The Lancet. Respiratory medicine vol. 10,1 (2022): 11-25. doi: https://doi.org/10.1016/S2213-2600(21)00322-2
Wechsler ME, Ford LB, Maspero JF, Pavord ID, Papi A, Bourdin A, Watz H, Castro M, Nenasheva NM, Tohda Y, Langton D, Cardona G, Domingo C, Park HS, Chapman KR, Mao X, Zhang Y, Khan AH, Deniz Y, Rowe PJ, Kapoor U, Khokhar FA, Mannent LP, Ruddy M, Laws E, Amin N, Hardin M. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. Lancet Respir Med. 2022 Jan;10(1):11-25. doi: 10.1016/S2213-2600(21)00322-2. Epub 2021 Sep 28. PMID: 34597534.
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Lancet Respir Med. 2022 Jan;10(1):11-25. doi: 10.1016/S2213-2600(21)00322-2. Epub 2021 Sep 28.

Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study.

The Lancet. Respiratory medicine

Michael E Wechsler, Linda B Ford, Jorge F Maspero, Ian D Pavord, Alberto Papi, Arnaud Bourdin, Henrik Watz, Mario Castro, Natalia M Nenasheva, Yuji Tohda, David Langton, Guido Cardona, Christian Domingo, Hae Sim Park, Kenneth R Chapman, Xuezhou Mao, Yi Zhang, Asif H Khan, Yamo Deniz, Paul J Rowe, Upender Kapoor, Faisal A Khokhar, Leda P Mannent, Marcella Ruddy, Elizabeth Laws, Nikhil Amin, Megan Hardin

Affiliations

  1. Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, CO, USA. Electronic address: [email protected].
  2. Asthma and Allergy Center, Bellevue, NE, USA.
  3. Allergy and Respiratory Medicine, Fundación CIDEA, Buenos Aires, Argentina.
  4. Respiratory Medicine, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.
  5. Respiratory Medicine Unit, University of Ferrara, Ferrara, Italy.
  6. Department of Respiratory Diseases, Université de Montpellier, CHU Montpellier, Montpellier, France; PhyMedExp, INSERM, CNRS, CHU Montpellier, Montpellier, France.
  7. Pulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Centre North, German Centre for Lung Research, Großhansdorf, Germany.
  8. Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kansas School of Medicine, Kansas City, KS, USA.
  9. Department of Allergology and Immunology, Russian Medical Academy of Continuous Professional Education, Moscow, Russia.
  10. Faculty of Medicine, Kindai University, ?sakasayama, Osaka, Japan.
  11. Department of Thoracic Medicine, Frankston Hospital, Frankston, VIC, Australia.
  12. Neumo Investigaciones SAS, Bogotá, Colombia.
  13. Pulmonary Service, Corporació Sanitària Parc Taulí, Sabadell, Universitat Autònoma de Barcelona, Barcelona, Spain.
  14. Department of Allergy and Clinical Immunology, Ajou University, Suwon, South Korea.
  15. Division of Respiratory Medicine, University of Toronto, Toronto, ON, Canada.
  16. Sanofi, Bridgewater, NJ, USA.
  17. Regeneron Pharmaceuticals, Tarrytown, NY, USA.
  18. Sanofi, Chilly Mazarin, France.

PMID: 34597534 DOI: 10.1016/S2213-2600(21)00322-2

Abstract

BACKGROUND: Clinical trials have shown treatment benefits of dupilumab in patients with uncontrolled asthma for up to 1 year. This study aimed to evaluate the long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma, as data for extended treatment with dupilumab beyond 1 year are not available.

METHODS: TRAVERSE was an open-label extension study in 362 hospitals and clinical centres across 27 countries that assessed the safety and efficacy of dupilumab 300 mg every 2 weeks up to 96 weeks in adults and adolescents (aged 12-84 years) with moderate-to-severe or oral-corticosteroid-dependent severe asthma who had completed a previous dupilumab asthma study (phase 2A EXPEDITION, phase 2B DRI [P2b], phase 3 QUEST, or VENTURE). The primary endpoint was the number and percentage of patients with any treatment-emergent adverse events. Secondary endpoints included annualised exacerbation rate (AER) over the treatment period and change from parent study baseline in pre-bronchodilator FEV

FINDINGS: Between Aug 5, 2014, and Oct 11, 2019, of 2302 patients assessed for eligibility, 2282 adults and adolescents were enrolled (median age 50 years, 62·1% female and 37·9% male). Safety during TRAVERSE was consistent with the known dupilumab safety profile. The proportion of patients reporting treatment-emergent adverse events throughout the study duration was similar to that observed in the parent studies and ranged from 76·3% to 94·7%. The most frequently reported treatment-emergent adverse events were nasopharyngitis (17·5-25·9%), injection-site erythema (2·2-23·4%), and bronchitis (9·3-19·0%). Serious asthma exacerbations (0·5-3·6%) and pneumonia (0·7-2·7%) were the most frequently reported serious adverse events. There were four treatment-emergent adverse events leading to death. Efficacy during TRAVERSE was also consistent with the results of parent studies. In patients who were non-oral-corticosteroid-dependent, AER remained low (0·277-0·327) across parent study and treatment groups, pre-bronchodilator FEV

INTERPRETATION: Data show that safety and efficacy of dupilumab in adult and adolescent patients with moderate-to-severe asthma are sustained when treatment is extended up to 148 weeks. These findings therefore support the long-term use of dupilumab in this patient population.

FUNDING: Sanofi and Regeneron Pharmaceuticals.

Copyright © 2022 Elsevier Ltd. All rights reserved.

Conflict of interest statement

Declaration of interests MEW reports personal fees from AstraZeneca, Boehringer Ingelheim, Equillium, Gala Therapeutics, Genentech, Genzyme, Mylan, Novartis, Pulmatrix, ResTORbio, Regeneron Pharmaceut

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