In the pooled analysis of Non-Dialysis Dependent (NDD) patients (n=4277):
- Roxadustat was statistically superior to placebo, demonstrating an improvement of 1.85 g/dL in patients’ Hb levels from baseline to the average over 28-52 weeks compared to 0.13 g/dL among patients in the placebo arm, for an overall treatment difference of 1.72 g/dL (p<0.001).
- The rate of rescue therapy required in the first year of treatment among patients treated with roxadustat (8.9%) was less than one third of the rate of the placebo arm (31.1%) p<0.0001; HR=0.19 (95% CI: 0.16, 0.23).
- The rate of red blood cell (RBC) transfusions required in the first year of treatment was also lower with roxadustat (5.2%) than placebo (15.4%) p<0.0001; HR=0.26 (95% CI: 0.21, 0.32).
- Roxadustat was statistically superior to epoetin alfa, demonstrating an improvement of 1.22 g/dL in patients’ Hb levels from baseline to the average over 28-52 weeks compared to 0.99 g/dL, for an overall treatment difference of 0.23 g/dL (p<0.0001).
- Roxadustat was superior to epoetin alfa across patients regardless of inflammation status, categorized by the baseline CRP levels (CRP > 4.9 mg/L), demonstrating an improvement of 1.29 g/dL and 1.27 g/dL in Hb levels from baseline in patients with and without inflammation, respectively, compared to 0.96 g/dL and 1.05 g/dL with epoetin alfa.
- The rate of RBC transfusions required in the first year of treatment was also lower with roxadustat (9.5%) than with epoetin alfa (12.8%) in DD patients (p=0.046). HR=0.82 (95% CI: 0.679, 0.997).
