RT Journal Article
SR Electronic
T1 Late Breaking Abstract - Identification of patients with COPD who benefit from benralizumab
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP RCT446
DO 10.1183/13993003.congress-2019.RCT446
VO 54
IS suppl 63
A1 Gerard J. Criner
A1 Bartolome R. Celli
A1 Dave Singh
A1 Maria Jison
A1 Natalya Makulova
A1 Vivian H. Shih
A1 Laura Brooks
A1 Peter Barker
A1 Ubaldo J. Martin
A1 Paul Newbold
YR 2019
UL http://erj.ersjournals.com/content/54/suppl_63/RCT446.abstract
AB Background: In GALATHEA/TERRANOVA Phase III trials (N Engl J Med. 2019; May 20), exacerbation reduction with benralizumab for patients with COPD did not reach statistical significance.Aims and Objectives: We evaluated baseline factors to identify patients demonstrating greater benralizumab efficacy.Methods: We pooled data from GALATHEA/TERRANOVA (N=3,910) for patients randomized to placebo or benralizumab (56 weeks). We ran prespecified statistical analyses to detect baseline factors that identified patients demonstrating greater reduction of moderate to severe COPD exacerbations with benralizumab 30 mg or 100 mg.Results: We identified several baseline efficacy factors: history of frequent exacerbations, lesser post-BD FEV1, greater post-BD FEV1 response, prior triple inhaled therapy use (figure). These factors identified greater efficacy with benralizumab 100 mg vs. placebo for patients with baseline eosinophils ≥220 cells/µL than for the overall population. Patients receiving benralizumab 100 mg with a combination of prior triple inhaled therapy use, baseline blood eosinophils ≥220 cells/µL, and ≥3 exacerbations (previous 12 months) demonstrated the greatest response (rate ratio vs. placebo [95% CI]: 0.70 [0.56, 0.88]).Conclusions: We identified a subpopulation of patients with specific traits who demonstrated a clinically meaningful benralizumab response. A Phase III trial is ongoing to evaluate benralizumab efficacy for these patients.FootnotesCite this article as: European Respiratory Journal 2019; 54: Suppl. 63, RCT446.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).