Efficacy of tezepelumab in patients with severe asthma and persistent airflow obstruction
Background Persistent airflow obstruction (PAO) in patients with asthma can be difficult to treat. Tezepelumab blocks thymic stromal lymphopoietin, an epithelial cytokine implicated in asthma pathogenesis. This analysis evaluated the efficacy of tezepelumab in patients with severe, uncontrolled asth...
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| Format: | Article |
| Language: | English |
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European Respiratory Society
2024-11-01
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| Series: | ERJ Open Research |
| Online Access: | http://openres.ersjournals.com/content/10/6/00164-2024.full |
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| author | Elliot Israel Mario Castro Christopher S. Ambrose Jean-Pierre Llanos Nestor A. Molfino Nicole L. Martin Sandhia S. Ponnarambil Neil Martin |
| author_facet | Elliot Israel Mario Castro Christopher S. Ambrose Jean-Pierre Llanos Nestor A. Molfino Nicole L. Martin Sandhia S. Ponnarambil Neil Martin |
| author_sort | Elliot Israel |
| collection | DOAJ |
| description | Background
Persistent airflow obstruction (PAO) in patients with asthma can be difficult to treat. Tezepelumab blocks thymic stromal lymphopoietin, an epithelial cytokine implicated in asthma pathogenesis. This analysis evaluated the efficacy of tezepelumab in patients with severe, uncontrolled asthma and PAO.
Methods
PATHWAY (phase 2b) and NAVIGATOR (phase 3) were multicentre, randomised, double-blind, placebo-controlled studies. This post hoc analysis included PATHWAY and NAVIGATOR patients who received tezepelumab 210 mg or placebo every 4 weeks for 52 weeks. Change from baseline to week 52 in pre-bronchodilator forced expiratory volume in 1 s (FEV1) and the annualised asthma exacerbation rate (AAER) over 52 weeks were assessed in patients with and without PAO (post-bronchodilator FEV1/forced vital capacity ratio <0.7) at baseline.
Results
Of the 1334 included patients, 782 (58.6%) had PAO at baseline. At week 52, greater improvements in pre-bronchodilator FEV1 from baseline were observed in tezepelumab versus placebo recipients with PAO (least-squares (LS) mean 0.24 versus 0.07 L; difference 0.17 L, 95% confidence interval (CI): 0.11–0.23) and without PAO (LS mean 0.20 versus 0.12 L; difference 0.08 L, 95% CI: 0.01–0.15). Tezepelumab reduced the AAER versus placebo by 61% (95% CI: 51–69) and 56% (95% CI: 42–67) in patients with and without PAO, respectively. For patients with PAO at baseline, the proportion without PAO at week 52 was higher with tezepelumab (12.1%) than placebo (6.6%) (odds ratio 1.96, 95% CI: 1.30–2.94).
Conclusion
Tezepelumab improved lung function and reduced exacerbations versus placebo in patients with severe, uncontrolled asthma with and without PAO. |
| format | Article |
| id | doaj-art-cd717c2bcd944430ab5baf77fb3e14c9 |
| institution | Kabale University |
| issn | 2312-0541 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | European Respiratory Society |
| record_format | Article |
| series | ERJ Open Research |
| spelling | doaj-art-cd717c2bcd944430ab5baf77fb3e14c92025-01-14T09:50:21ZengEuropean Respiratory SocietyERJ Open Research2312-05412024-11-0110610.1183/23120541.00164-202400164-2024Efficacy of tezepelumab in patients with severe asthma and persistent airflow obstructionElliot Israel0Mario Castro1Christopher S. Ambrose2Jean-Pierre Llanos3Nestor A. Molfino4Nicole L. Martin5Sandhia S. Ponnarambil6Neil Martin7 Pulmonary and Critical Care Medicine, Allergy and Immunology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA Division of Pulmonary, Critical Care and Sleep Medicine, University of Kansas School of Medicine, Kansas City, KS, USA Respiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA Global Medical Affairs, Amgen, Thousand Oaks, CA, USA Global Development, Amgen, Thousand Oaks, CA, USA Biometrics, Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Waltham, MA, USA Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK Respiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK Background Persistent airflow obstruction (PAO) in patients with asthma can be difficult to treat. Tezepelumab blocks thymic stromal lymphopoietin, an epithelial cytokine implicated in asthma pathogenesis. This analysis evaluated the efficacy of tezepelumab in patients with severe, uncontrolled asthma and PAO. Methods PATHWAY (phase 2b) and NAVIGATOR (phase 3) were multicentre, randomised, double-blind, placebo-controlled studies. This post hoc analysis included PATHWAY and NAVIGATOR patients who received tezepelumab 210 mg or placebo every 4 weeks for 52 weeks. Change from baseline to week 52 in pre-bronchodilator forced expiratory volume in 1 s (FEV1) and the annualised asthma exacerbation rate (AAER) over 52 weeks were assessed in patients with and without PAO (post-bronchodilator FEV1/forced vital capacity ratio <0.7) at baseline. Results Of the 1334 included patients, 782 (58.6%) had PAO at baseline. At week 52, greater improvements in pre-bronchodilator FEV1 from baseline were observed in tezepelumab versus placebo recipients with PAO (least-squares (LS) mean 0.24 versus 0.07 L; difference 0.17 L, 95% confidence interval (CI): 0.11–0.23) and without PAO (LS mean 0.20 versus 0.12 L; difference 0.08 L, 95% CI: 0.01–0.15). Tezepelumab reduced the AAER versus placebo by 61% (95% CI: 51–69) and 56% (95% CI: 42–67) in patients with and without PAO, respectively. For patients with PAO at baseline, the proportion without PAO at week 52 was higher with tezepelumab (12.1%) than placebo (6.6%) (odds ratio 1.96, 95% CI: 1.30–2.94). Conclusion Tezepelumab improved lung function and reduced exacerbations versus placebo in patients with severe, uncontrolled asthma with and without PAO.http://openres.ersjournals.com/content/10/6/00164-2024.full |
| spellingShingle | Elliot Israel Mario Castro Christopher S. Ambrose Jean-Pierre Llanos Nestor A. Molfino Nicole L. Martin Sandhia S. Ponnarambil Neil Martin Efficacy of tezepelumab in patients with severe asthma and persistent airflow obstruction ERJ Open Research |
| title | Efficacy of tezepelumab in patients with severe asthma and persistent airflow obstruction |
| title_full | Efficacy of tezepelumab in patients with severe asthma and persistent airflow obstruction |
| title_fullStr | Efficacy of tezepelumab in patients with severe asthma and persistent airflow obstruction |
| title_full_unstemmed | Efficacy of tezepelumab in patients with severe asthma and persistent airflow obstruction |
| title_short | Efficacy of tezepelumab in patients with severe asthma and persistent airflow obstruction |
| title_sort | efficacy of tezepelumab in patients with severe asthma and persistent airflow obstruction |
| url | http://openres.ersjournals.com/content/10/6/00164-2024.full |
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