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Dupilumab is effective in type 2‐high asthma patients receiving high‐dose inhaled corticosteroids at baseline
BACKGROUND: Dupilumab blocks the shared receptor component for interleukin (IL)‐4/IL‐13, key drivers of type 2 inflammation. In phase 2b (NCT01854047) and phase 3 LIBERTY ASTHMA QUEST (NCT02414854), add‐on dupilumab 200/300 mg every 2 weeks (q2w) reduced severe exacerbations, improved prebronchodila...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7820970/ https://www.ncbi.nlm.nih.gov/pubmed/33010038 http://dx.doi.org/10.1111/all.14611 |
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author | Bourdin, Arnaud Papi, Alberto A. Corren, Jonathan Virchow, J. Christian Rice, Megan S. Deniz, Yamo Djandji, Michel Rowe, Paul Pavord, Ian D. |
author_facet | Bourdin, Arnaud Papi, Alberto A. Corren, Jonathan Virchow, J. Christian Rice, Megan S. Deniz, Yamo Djandji, Michel Rowe, Paul Pavord, Ian D. |
author_sort | Bourdin, Arnaud |
collection | PubMed |
description | BACKGROUND: Dupilumab blocks the shared receptor component for interleukin (IL)‐4/IL‐13, key drivers of type 2 inflammation. In phase 2b (NCT01854047) and phase 3 LIBERTY ASTHMA QUEST (NCT02414854), add‐on dupilumab 200/300 mg every 2 weeks (q2w) reduced severe exacerbations, improved prebronchodilator (pre‐BD) forced expiratory volume in 1 second (FEV(1)) and quality of life measures, and it was generally well tolerated in patients with uncontrolled, persistent (phase 2b), or moderate‐to‐severe (phase 3) asthma. METHODS: In patients on high‐dose inhaled corticosteroids (ICS) with type 2‐high asthma (subgroups including baseline blood eosinophils ≥150/300 cells/µL and/or fractional exhaled nitric oxide [FeNO] ≥25 ppb), annualized severe exacerbation rates over the treatment period, changes from baseline in pre‐BD FEV(1) and asthma control (5‐item asthma control questionnaire [ACQ‐5]) were analyzed. RESULTS: In high‐dose ICS type 2‐high subgroups, dupilumab 200/300 mg q2w vs placebo in the phase 2b (24 weeks) and phase 3 (52 weeks) studies significantly reduced severe exacerbations by 55%‐69%/57%‐60% (all P<.05) and 53%‐69%/48%‐66% (all P < .001), respectively, except in patients with ≥ 300 eosinophils/µL in phase 2b study (24%/50% (P = .52/0.15). Across subgroups, pre‐BD FEV(1) improved by 0.18‐0.22 L/0.19‐0.24 L (all P < .05) and 0.23‐0.36 L/0.15‐0.25 L (all P < .01) and ACQ‐5 scores were reduced by 0.46‐0.55/0.47‐0.85 (all P < .05) and 0.38‐0.50/0.24‐0.30 (all P < .05), respectively, except dupilumab 200 mg q2w in phase 2b in patients with FeNO ≥ 25 ppb (0.41; P = .09). Dupilumab was also effective in patients taking medium‐dose ICS. CONCLUSION: Dupilumab significantly reduced severe exacerbations and improved lung function and asthma control in patients with type 2‐high asthma on high‐dose ICS at baseline. |
format | Online Article Text |
id | pubmed-7820970 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-78209702021-01-26 Dupilumab is effective in type 2‐high asthma patients receiving high‐dose inhaled corticosteroids at baseline Bourdin, Arnaud Papi, Alberto A. Corren, Jonathan Virchow, J. Christian Rice, Megan S. Deniz, Yamo Djandji, Michel Rowe, Paul Pavord, Ian D. Allergy ORIGINAL ARTICLES BACKGROUND: Dupilumab blocks the shared receptor component for interleukin (IL)‐4/IL‐13, key drivers of type 2 inflammation. In phase 2b (NCT01854047) and phase 3 LIBERTY ASTHMA QUEST (NCT02414854), add‐on dupilumab 200/300 mg every 2 weeks (q2w) reduced severe exacerbations, improved prebronchodilator (pre‐BD) forced expiratory volume in 1 second (FEV(1)) and quality of life measures, and it was generally well tolerated in patients with uncontrolled, persistent (phase 2b), or moderate‐to‐severe (phase 3) asthma. METHODS: In patients on high‐dose inhaled corticosteroids (ICS) with type 2‐high asthma (subgroups including baseline blood eosinophils ≥150/300 cells/µL and/or fractional exhaled nitric oxide [FeNO] ≥25 ppb), annualized severe exacerbation rates over the treatment period, changes from baseline in pre‐BD FEV(1) and asthma control (5‐item asthma control questionnaire [ACQ‐5]) were analyzed. RESULTS: In high‐dose ICS type 2‐high subgroups, dupilumab 200/300 mg q2w vs placebo in the phase 2b (24 weeks) and phase 3 (52 weeks) studies significantly reduced severe exacerbations by 55%‐69%/57%‐60% (all P<.05) and 53%‐69%/48%‐66% (all P < .001), respectively, except in patients with ≥ 300 eosinophils/µL in phase 2b study (24%/50% (P = .52/0.15). Across subgroups, pre‐BD FEV(1) improved by 0.18‐0.22 L/0.19‐0.24 L (all P < .05) and 0.23‐0.36 L/0.15‐0.25 L (all P < .01) and ACQ‐5 scores were reduced by 0.46‐0.55/0.47‐0.85 (all P < .05) and 0.38‐0.50/0.24‐0.30 (all P < .05), respectively, except dupilumab 200 mg q2w in phase 2b in patients with FeNO ≥ 25 ppb (0.41; P = .09). Dupilumab was also effective in patients taking medium‐dose ICS. CONCLUSION: Dupilumab significantly reduced severe exacerbations and improved lung function and asthma control in patients with type 2‐high asthma on high‐dose ICS at baseline. John Wiley and Sons Inc. 2020-10-21 2021-01 /pmc/articles/PMC7820970/ /pubmed/33010038 http://dx.doi.org/10.1111/all.14611 Text en © 2020 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | ORIGINAL ARTICLES Bourdin, Arnaud Papi, Alberto A. Corren, Jonathan Virchow, J. Christian Rice, Megan S. Deniz, Yamo Djandji, Michel Rowe, Paul Pavord, Ian D. Dupilumab is effective in type 2‐high asthma patients receiving high‐dose inhaled corticosteroids at baseline |
title | Dupilumab is effective in type 2‐high asthma patients receiving high‐dose inhaled corticosteroids at baseline |
title_full | Dupilumab is effective in type 2‐high asthma patients receiving high‐dose inhaled corticosteroids at baseline |
title_fullStr | Dupilumab is effective in type 2‐high asthma patients receiving high‐dose inhaled corticosteroids at baseline |
title_full_unstemmed | Dupilumab is effective in type 2‐high asthma patients receiving high‐dose inhaled corticosteroids at baseline |
title_short | Dupilumab is effective in type 2‐high asthma patients receiving high‐dose inhaled corticosteroids at baseline |
title_sort | dupilumab is effective in type 2‐high asthma patients receiving high‐dose inhaled corticosteroids at baseline |
topic | ORIGINAL ARTICLES |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7820970/ https://www.ncbi.nlm.nih.gov/pubmed/33010038 http://dx.doi.org/10.1111/all.14611 |
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