Benralizumab for the Prevention of COPD Exacerbations
BACKGROUND: The efficacy and safety of benralizumab, an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody, for the prevention of exacerbations in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) are not known. METHODS: In the GALATHEA and TERRANOVA...
Published in: | New England Journal of Medicine |
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2019
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Online Access: | https://portal.findresearcher.sdu.dk/da/publications/c6394254-2501-466b-85d2-908fcea59774 https://doi.org/10.1056/NEJMoa1905248 https://findresearcher.sdu.dk/ws/files/161061854/nejmoa1905248.pdf |
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ftsydanskunivpub:oai:sdu.dk:publications/c6394254-2501-466b-85d2-908fcea59774 2024-09-15T18:38:51+00:00 Benralizumab for the Prevention of COPD Exacerbations Criner, Gerard J Celli, Bartolome R Brightling, Christopher E Agusti, Alvar Papi, Alberto Singh, Dave Sin, Don D Vogelmeier, Claus F Sciurba, Frank C Bafadhel, Mona Backer, Vibeke Kato, Motokazu Ramírez-Venegas, Alejandra Wei, Yu-Feng Bjermer, Leif Shih, Vivian H Jison, Maria O'Quinn, Sean Makulova, Natalya Newbold, Paul Goldman, Mitchell Martin, Ubaldo J Bødtger, Uffe 2019-09-12 application/pdf https://portal.findresearcher.sdu.dk/da/publications/c6394254-2501-466b-85d2-908fcea59774 https://doi.org/10.1056/NEJMoa1905248 https://findresearcher.sdu.dk/ws/files/161061854/nejmoa1905248.pdf eng eng https://portal.findresearcher.sdu.dk/da/publications/c6394254-2501-466b-85d2-908fcea59774 info:eu-repo/semantics/openAccess Criner , G J , Celli , B R , Brightling , C E , Agusti , A , Papi , A , Singh , D , Sin , D D , Vogelmeier , C F , Sciurba , F C , Bafadhel , M , Backer , V , Kato , M , Ramírez-Venegas , A , Wei , Y-F , Bjermer , L , Shih , V H , Jison , M , O'Quinn , S , Makulova , N , Newbold , P , Goldman , M , Martin , U J , GALATHEA Study Investigators , Bødtger , U & TERRANOVA Study Investigators 2019 , ' Benralizumab for the Prevention of COPD Exacerbations ' , The New England Journal of Medicine , vol. 381 , no. 11 , pp. 1023-1034 . https://doi.org/10.1056/NEJMoa1905248 Aged Anti-Asthmatic Agents/administration & dosage Antibodies Monoclonal Humanized/administration & dosage Double-Blind Method Eosinophils/metabolism Female Humans Injections Subcutaneous Leukocyte Count Male Middle Aged Patient Acuity Pulmonary Disease Chronic Obstructive/drug therapy Receptors Interleukin-5/antagonists & inhibitors article 2019 ftsydanskunivpub https://doi.org/10.1056/NEJMoa1905248 2024-08-12T23:48:15Z BACKGROUND: The efficacy and safety of benralizumab, an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody, for the prevention of exacerbations in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) are not known. METHODS: In the GALATHEA and TERRANOVA trials, we enrolled patients with COPD (at a ratio of approximately 2:1 on the basis of eosinophil count [≥220 per cubic millimeter vs. <220 per cubic millimeter]) who had frequent exacerbations despite receiving guideline-based inhaled treatment. Patients were randomly assigned to receive benralizumab (30 or 100 mg in GALATHEA; 10, 30, or 100 mg in TERRANOVA) every 8 weeks (every 4 weeks for the first three doses) or placebo. The primary end point was the treatment effect of benralizumab, measured as the annualized COPD exacerbation rate ratio (benralizumab vs. placebo) at week 56 in patients with baseline blood eosinophil counts of 220 per cubic millimeter or greater. Safety was also assessed. RESULTS: In GALATHEA, the estimates of the annualized exacerbation rate were 1.19 per year (95% confidence interval [CI], 1.04 to 1.36) in the 30-mg benralizumab group, 1.03 per year (95% CI, 0.90 to 1.19) in the 100-mg benralizumab group, and 1.24 per year (95% CI, 1.08 to 1.42) in the placebo group; the rate ratio as compared with placebo was 0.96 for 30 mg of benralizumab (P = 0.65) and 0.83 for 100 mg of benralizumab (P = 0.05). In TERRANOVA, the estimates of the annualized exacerbation rate for 10 mg, 30 mg, and 100 mg of benralizumab and for placebo were 0.99 per year (95% CI, 0.87 to 1.13), 1.21 per year (95% CI, 1.08 to 1.37), 1.09 per year (95% CI, 0.96 to 1.23), and 1.17 per year (95% CI, 1.04 to 1.32), respectively; the corresponding rate ratios were 0.85 (P = 0.06), 1.04 (P = 0.66), and 0.93 (P = 0.40). At 56 weeks, none of the annualized COPD exacerbation rate ratios for any dose of benralizumab as compared with placebo reached significance in either trial. Types and frequencies of adverse events were similar ... Article in Journal/Newspaper Terranova University of Southern Denmark Research Portal New England Journal of Medicine 381 11 1023 1034 |
institution |
Open Polar |
collection |
University of Southern Denmark Research Portal |
op_collection_id |
ftsydanskunivpub |
language |
English |
topic |
Aged Anti-Asthmatic Agents/administration & dosage Antibodies Monoclonal Humanized/administration & dosage Double-Blind Method Eosinophils/metabolism Female Humans Injections Subcutaneous Leukocyte Count Male Middle Aged Patient Acuity Pulmonary Disease Chronic Obstructive/drug therapy Receptors Interleukin-5/antagonists & inhibitors |
spellingShingle |
Aged Anti-Asthmatic Agents/administration & dosage Antibodies Monoclonal Humanized/administration & dosage Double-Blind Method Eosinophils/metabolism Female Humans Injections Subcutaneous Leukocyte Count Male Middle Aged Patient Acuity Pulmonary Disease Chronic Obstructive/drug therapy Receptors Interleukin-5/antagonists & inhibitors Criner, Gerard J Celli, Bartolome R Brightling, Christopher E Agusti, Alvar Papi, Alberto Singh, Dave Sin, Don D Vogelmeier, Claus F Sciurba, Frank C Bafadhel, Mona Backer, Vibeke Kato, Motokazu Ramírez-Venegas, Alejandra Wei, Yu-Feng Bjermer, Leif Shih, Vivian H Jison, Maria O'Quinn, Sean Makulova, Natalya Newbold, Paul Goldman, Mitchell Martin, Ubaldo J Bødtger, Uffe Benralizumab for the Prevention of COPD Exacerbations |
topic_facet |
Aged Anti-Asthmatic Agents/administration & dosage Antibodies Monoclonal Humanized/administration & dosage Double-Blind Method Eosinophils/metabolism Female Humans Injections Subcutaneous Leukocyte Count Male Middle Aged Patient Acuity Pulmonary Disease Chronic Obstructive/drug therapy Receptors Interleukin-5/antagonists & inhibitors |
description |
BACKGROUND: The efficacy and safety of benralizumab, an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody, for the prevention of exacerbations in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) are not known. METHODS: In the GALATHEA and TERRANOVA trials, we enrolled patients with COPD (at a ratio of approximately 2:1 on the basis of eosinophil count [≥220 per cubic millimeter vs. <220 per cubic millimeter]) who had frequent exacerbations despite receiving guideline-based inhaled treatment. Patients were randomly assigned to receive benralizumab (30 or 100 mg in GALATHEA; 10, 30, or 100 mg in TERRANOVA) every 8 weeks (every 4 weeks for the first three doses) or placebo. The primary end point was the treatment effect of benralizumab, measured as the annualized COPD exacerbation rate ratio (benralizumab vs. placebo) at week 56 in patients with baseline blood eosinophil counts of 220 per cubic millimeter or greater. Safety was also assessed. RESULTS: In GALATHEA, the estimates of the annualized exacerbation rate were 1.19 per year (95% confidence interval [CI], 1.04 to 1.36) in the 30-mg benralizumab group, 1.03 per year (95% CI, 0.90 to 1.19) in the 100-mg benralizumab group, and 1.24 per year (95% CI, 1.08 to 1.42) in the placebo group; the rate ratio as compared with placebo was 0.96 for 30 mg of benralizumab (P = 0.65) and 0.83 for 100 mg of benralizumab (P = 0.05). In TERRANOVA, the estimates of the annualized exacerbation rate for 10 mg, 30 mg, and 100 mg of benralizumab and for placebo were 0.99 per year (95% CI, 0.87 to 1.13), 1.21 per year (95% CI, 1.08 to 1.37), 1.09 per year (95% CI, 0.96 to 1.23), and 1.17 per year (95% CI, 1.04 to 1.32), respectively; the corresponding rate ratios were 0.85 (P = 0.06), 1.04 (P = 0.66), and 0.93 (P = 0.40). At 56 weeks, none of the annualized COPD exacerbation rate ratios for any dose of benralizumab as compared with placebo reached significance in either trial. Types and frequencies of adverse events were similar ... |
format |
Article in Journal/Newspaper |
author |
Criner, Gerard J Celli, Bartolome R Brightling, Christopher E Agusti, Alvar Papi, Alberto Singh, Dave Sin, Don D Vogelmeier, Claus F Sciurba, Frank C Bafadhel, Mona Backer, Vibeke Kato, Motokazu Ramírez-Venegas, Alejandra Wei, Yu-Feng Bjermer, Leif Shih, Vivian H Jison, Maria O'Quinn, Sean Makulova, Natalya Newbold, Paul Goldman, Mitchell Martin, Ubaldo J Bødtger, Uffe |
author_facet |
Criner, Gerard J Celli, Bartolome R Brightling, Christopher E Agusti, Alvar Papi, Alberto Singh, Dave Sin, Don D Vogelmeier, Claus F Sciurba, Frank C Bafadhel, Mona Backer, Vibeke Kato, Motokazu Ramírez-Venegas, Alejandra Wei, Yu-Feng Bjermer, Leif Shih, Vivian H Jison, Maria O'Quinn, Sean Makulova, Natalya Newbold, Paul Goldman, Mitchell Martin, Ubaldo J Bødtger, Uffe |
author_sort |
Criner, Gerard J |
title |
Benralizumab for the Prevention of COPD Exacerbations |
title_short |
Benralizumab for the Prevention of COPD Exacerbations |
title_full |
Benralizumab for the Prevention of COPD Exacerbations |
title_fullStr |
Benralizumab for the Prevention of COPD Exacerbations |
title_full_unstemmed |
Benralizumab for the Prevention of COPD Exacerbations |
title_sort |
benralizumab for the prevention of copd exacerbations |
publishDate |
2019 |
url |
https://portal.findresearcher.sdu.dk/da/publications/c6394254-2501-466b-85d2-908fcea59774 https://doi.org/10.1056/NEJMoa1905248 https://findresearcher.sdu.dk/ws/files/161061854/nejmoa1905248.pdf |
genre |
Terranova |
genre_facet |
Terranova |
op_source |
Criner , G J , Celli , B R , Brightling , C E , Agusti , A , Papi , A , Singh , D , Sin , D D , Vogelmeier , C F , Sciurba , F C , Bafadhel , M , Backer , V , Kato , M , Ramírez-Venegas , A , Wei , Y-F , Bjermer , L , Shih , V H , Jison , M , O'Quinn , S , Makulova , N , Newbold , P , Goldman , M , Martin , U J , GALATHEA Study Investigators , Bødtger , U & TERRANOVA Study Investigators 2019 , ' Benralizumab for the Prevention of COPD Exacerbations ' , The New England Journal of Medicine , vol. 381 , no. 11 , pp. 1023-1034 . https://doi.org/10.1056/NEJMoa1905248 |
op_relation |
https://portal.findresearcher.sdu.dk/da/publications/c6394254-2501-466b-85d2-908fcea59774 |
op_rights |
info:eu-repo/semantics/openAccess |
op_doi |
https://doi.org/10.1056/NEJMoa1905248 |
container_title |
New England Journal of Medicine |
container_volume |
381 |
container_issue |
11 |
container_start_page |
1023 |
op_container_end_page |
1034 |
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1810483260307800064 |