View in EDS

Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation

Saved in:
Bibliographic Details
Title: Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation
Authors: Bhatt, Surya P, Rabe, Klaus F, Hanania, Nicola A, Vogelmeier, Claus F, Bafadhel, Mona, Christenson, Stephanie A, Papi, Alberto, Singh, Dave, Laws, Elizabeth, Patel, Naimish, Yancopoulos, George D, Akinlade, Bolanle, Maloney, Jennifer, Lu, Xin, Bauer, Deborah, Bansal, Ashish, Abdulai, Raolat M, Robinson, Lacey B
Source: New England Journal of Medicine. 390:2274-2283
Publisher Information: Massachusetts Medical Society, 2024.
Publication Year: 2024
Subject Terms: Male, Inflammation, Injections, Subcutaneous, Smoking, Middle Aged, Antibodies, Monoclonal, Humanized, Eosinophils, Leukocyte Count, Pulmonary Disease, Chronic Obstructive, Double-Blind Method, Forced Expiratory Volume, Quality of Life, Disease Progression, Humans, Female, Chronic obstructive pulmonary disease (COPD), dupilumab, monoclonal antibody, type 2 inflammation, blood eosinophils, COPD exacerbation, lung function, Aged
Description: Dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for interleukin-4 and interleukin-13, key and central drivers of type 2 inflammation, has shown efficacy and safety in a phase 3 trial involving patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation and an elevated risk of exacerbation. Whether the findings would be confirmed in a second phase 3 trial was unclear.In a phase 3, double-blind, randomized trial, we assigned patients with COPD who had a blood eosinophil count of 300 cells per microliter or higher to receive subcutaneous dupilumab (300 mg) or placebo every 2 weeks. The primary end point was the annualized rate of moderate or severe exacerbations. Key secondary end points, analyzed in a hierarchical manner to adjust for multiplicity, included the changes from baseline in the prebronchodilator forced expiratory volume in 1 second (FEV1) at weeks 12 and 52 and in the St. George's Respiratory Questionnaire (SGRQ; scores range from 0 to 100, with lower scores indicating better quality of life) total score at week 52.A total of 935 patients underwent randomization: 470 were assigned to the dupilumab group and 465 to the placebo group. As prespecified, the primary analysis was performed after a positive interim analysis and included all available data for the 935 participants, 721 of whom were included in the analysis at week 52. The annualized rate of moderate or severe exacerbations was 0.86 (95% confidence interval [CI], 0.70 to 1.06) with dupilumab and 1.30 (95% CI, 1.05 to 1.60) with placebo; the rate ratio as compared with placebo was 0.66 (95% CI, 0.54 to 0.82; P
Document Type: Article
File Description: application/pdf
Language: English
ISSN: 1533-4406
0028-4793
DOI: 10.1056/nejmoa2401304
Access URL: https://pubmed.ncbi.nlm.nih.gov/38767614
https://www.nejm.org/doi/full/10.1056/NEJMoa2401304
https://doi.org/10.1056/NEJMoa2401304
https://hdl.handle.net/11392/2552610
Rights: URL: http://www.nejmgroup.org/legal/terms-of-use.htm
Accession Number: edsair.doi.dedup.....21960363e3c7981a7599438b9d2cb6a8
Database: OpenAIRE
Description
Abstract:Dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for interleukin-4 and interleukin-13, key and central drivers of type 2 inflammation, has shown efficacy and safety in a phase 3 trial involving patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation and an elevated risk of exacerbation. Whether the findings would be confirmed in a second phase 3 trial was unclear.In a phase 3, double-blind, randomized trial, we assigned patients with COPD who had a blood eosinophil count of 300 cells per microliter or higher to receive subcutaneous dupilumab (300 mg) or placebo every 2 weeks. The primary end point was the annualized rate of moderate or severe exacerbations. Key secondary end points, analyzed in a hierarchical manner to adjust for multiplicity, included the changes from baseline in the prebronchodilator forced expiratory volume in 1 second (FEV1) at weeks 12 and 52 and in the St. George's Respiratory Questionnaire (SGRQ; scores range from 0 to 100, with lower scores indicating better quality of life) total score at week 52.A total of 935 patients underwent randomization: 470 were assigned to the dupilumab group and 465 to the placebo group. As prespecified, the primary analysis was performed after a positive interim analysis and included all available data for the 935 participants, 721 of whom were included in the analysis at week 52. The annualized rate of moderate or severe exacerbations was 0.86 (95% confidence interval [CI], 0.70 to 1.06) with dupilumab and 1.30 (95% CI, 1.05 to 1.60) with placebo; the rate ratio as compared with placebo was 0.66 (95% CI, 0.54 to 0.82; P
ISSN:15334406
00284793
DOI:10.1056/nejmoa2401304