Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
Summary
The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies
Timeline
- Start
- 2014-06-13
- Primary completion
- 2018-04-10
- Completion
- 2018-04-10
Outcome
Missed primary endpoint
registry analysis (superiority test); Benralizumab 30 mg vs Placebo; p = 0.6490; Rate ratio 0.96 (95% CI 0.8 to 1.15); Negative binomial NCT02138916 ↗
registry analysis (superiority test); Benralizumab 100 mg vs Placebo; p = 0.0525; Risk Ratio (RR) 0.83 (95% CI 0.69 to 1.00); Negative binomial NCT02138916 ↗
paper 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. PMID 31112385 ↗
release “GALATHEA Phase III trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with COPD” astrazeneca.com ↗
Publications
- Criner GJ, Celli BR, Singh D, Agusti A, Papi A, Jison M, Makulova N, Shih VH, Brooks L, Barker P, Martin UJ, Newbold P. Predicting response to benralizumab in chronic obstructive pulmonary disease: analyses of GALATHEA and TERRANOVA studies. Lancet Respir Med. 2020 Feb;8(2):158-170. doi: 10.1016/S2213-2600(19)30338-8. Epub 2019 Sep 28.
- Criner GJ, Celli BR, Brightling CE, Agusti A, Papi A, Singh D, Sin DD, Vogelmeier CF, Sciurba FC, Bafadhel M, Backer V, Kato M, Ramirez-Venegas A, Wei YF, Bjermer L, Shih VH, Jison M, O'Quinn S, Makulova N, Newbold P, Goldman M, Martin UJ; GALATHEA Study Investigators; TERRANOVA Study Investigators. Benralizumab for the Prevention of COPD Exacerbations. N Engl J Med. 2019 Sep 12;381(11):1023-1034. doi: 10.1056/NEJMoa1905248. Epub 2019 May 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benralizumab | Monoclonal antibody | 30 mg | Subcutaneous |
| Subject | Benralizumab | Monoclonal antibody | 100 mg | Subcutaneous |