Abstract: PO2367
Efficacy and Safety of Roxadustat for the Treatment of CKD Anemia in Patients Enrolled in the United States as Compared with the Global Cohort
Session Information
- CKD: Insights from Recent Clinical Trials and Large Real-World Effectiveness Studies
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Bansal, Shweta, The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
- Nassar, George M., Weill Cornell Medicine, New York, New York, United States
- Lynn, Robert I., Albert Einstein College of Medicine, Bronx, New York, United States
- Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States
- Lee, Tyson T., FibroGen Inc, San Francisco, California, United States
- Saikali, Khalil Georges, FibroGen Inc, San Francisco, California, United States
- Szczech, Lynda, FibroGen Inc, San Francisco, California, United States
Background
Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor increases hemoglobin (Hb) in non-dialysis (NDD) and dialysis dependent (DD) chronic kidney disease (CKD). Because of different clinical practices and demographic factors, it is important to evaluate efficacy and safety by region.
Methods
In a secondary analysis of data from 3 phase 3 studies of Roxadustat vs. placebo in NDD-, and 3 phase 3 studies of Roxadustat vs. epoetin alfa in DD-CKD, US patients were compared to the global cohort. Mean change from baseline in Hb averaged over weeks 28–52 regardless of rescue therapy and treatment emergent adverse events with occurrence in ≥5% of patients were assessed.
Results
Of the patients enrolled in the NDD and DD trials, 23.2% and 45.4% were enrolled in the US, respectively. Compared with global patients, US patients were older, had a higher BMI, and more frequently had type I or II diabetes mellitus and cardiovascular/thromboembolic diseases (Table). US DD patients had a higher mean baseline Hb (SD) (10.16 g/dL [0.92]) compared with the global cohort (9.65[1.30]). Efficacy was similar between US and global patients; least square mean (LSM) differences in NDD patients were 1.61 g/dL (95% CI: 1.48, 1.74) vs. 1.72 (95% CI:1.65, 1.79) (both p<0.0001) comparing roxadustat to placebo; LSM differences in DD patients were 0.33 (95% CI: 0.24, 0.42) vs. 0.26 (95% CI: 0.20, 0.33) (both p<0.0001) comparing roxadustat to epoeitin alfa. Safety was comparable between treatment arms in US and global patients.
Conclusion
Patients enrolled in the US were older and were more likely to have comorbidities in both the NDD and DD trials, Roxadustat efficacy and safety in the US were similar to global patients.
Funding
- Commercial Support – FibroGen, Inc., Astellas, AstraZeneca