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Abstract: PO0259

Subgroup Analyses of Efficacy of Roxadustat for Treatment of Anemia in Patients with Incident Dialysis-Dependent CKD

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Provenzano, Robert, Wayne State University, Detroit, Michigan, United States
  • Kumar, Jayant, Renal Medicine Associates, Albuquerque, New Mexico, United States
  • Fishbane, Steven, Northwell Health, Great Neck, New York, United States
  • Rastogi, Anjay, University of California Los Angeles, Los Angeles, California, United States
  • Poole, Lona, FibroGen Inc, San Francisco, California, United States
  • Liu, Cameron S., FibroGen Inc, San Francisco, California, United States
  • Little, Dustin J., AstraZeneca, Gaithersburg, Maryland, United States
  • Yu, Kin-Hung Peony, FibroGen Inc, San Francisco, California, United States
Background

Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and improves iron metabolism.

Methods

Pooled data from 3 pivotal phase 3 studies of roxadustat v. epoetin alfa forincident–dialysis-dependent dialysis patients (ID-DD; on dialysis for ≤4 m)were assessed. Prespecified, subgroups were analyzed for mean change from baseline (CFB) in hemoglobin (Hb) (weeks 28–52 regardless of rescue therapy) and mean monthly IV iron use (Weeks 28–52). Death, MI, and stroke (MACE), as well as heart failure or unstable angina requiring hospitalization (MACE+) were adjudicated.

Results

Roxadustat- (n=760) v. epoetin alfa-treated patients (n=770) achieved non-inferiority (NI:lower limit of 95% CI >0), and a significantly larger mean (SD) CFB in Hb (g/dL) (2.12 [1.45] v. 1.91 [1.42]), with a least-squares mean (LSM) difference of 0.22 (95% CI: 0.05, 0.40) (p=0.013). All subgroupswere consistent with the overall population, achieving NI for Hb CFB (Table). Subgroup analyses of mean monthly IV iron use during Weeks 28–52 were significant in favor of roxadustat v. epoetin alfa in the overall population and by age group (18–64), gender (male), race (white), region (US, Europe), baseline iron status (ferritin ≥100 ng/mL & TSAT ≥20%), baseline Hb (<8.0 and ≥8.0 g/dL), and dialysis modality (hemodialysis). HR of MACE and MACE+ were lower in the roxadustat v. epoetin alfa group: 0.70 (95% CI: 0.51, 0.96) (p=0.03) and 0.66 (95% CI: 0.50, 0.89) (p=0.005).

Conclusion

The efficacy of roxadustat vs. epoetin alfa for improving Hb level and reducing IV iron use was consistent across prespecified subgroups in the ID-DD population. Roxadustat reduced MACE and MACE+ vs. epoetin alfa.

Funding

  • Commercial Support