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ARTICLE | Clinical News

Benralizumab: Phase IIa data

September 15, 2014 7:00 AM UTC

Data from 82 patients with moderate to severe COPD and an elevated sputum eosinophil count in the per protocol (PP) population of a double-blind, international Phase IIa trial in 101 patients showed that subcutaneous benralizumab missed the primary endpoint of reducing the annual rate of acute exacerbations of COPD vs. placebo (0.95 vs. 0.92). Benralizumab met the secondary endpoint of increasing mean pre-bronchodilator FEV1 from baseline to week 56 vs. placebo (0.13 L vs. a reduction of 0.06 L, p=0.014). In pre-specified subgroups of patients with baseline blood eosinophil concentrations of >=200 cells/UL and >=300 cells/UL, benralizumab non-significantly improved acute exacerbations of COPD, SGRQ-C scores and CRQ scores vs. placebo. Benralizumab significantly improved mean pre-bronchodilator FEV1 from baseline to week 56 vs. placebo in patients with a baseline blood eosinophil concentration of >=200 cells/UL (p=0.035), but non-significantly improved the endpoint in patients with a baseline blood eosinophil concentration of >=300 cells/UL (p=0.22). Patients received placebo or 100 mg benralizumab every 4 weeks for 3 doses and then every 8 weeks for 5 doses. Data were published in The Lancet Respiratory Medicine and presented at the European Respiratory Society meeting in Munich. ...