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Abstract: PO0260

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

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Coyne, Daniel W., Washington University School of Medicine, St. Louis, Missouri, United States
  • El-Shahawy, Mohamed A., Keck School of Medicine, University of Southern California, Los Angeles, California, United States
  • Pecoits-Filho, Roberto, Arbor Research Collaborative for Health, Ann Arbor, United States
  • Gurcan, Hakan M., FibroGen Inc, San Francisco, California, United States
  • Liu, Cameron S., FibroGen Inc, San Francisco, California, United States
  • Hardy, Elise, AstraZeneca, Gaithersburg, Maryland, United States
  • Houghton, John, 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

Data from three pivotal, phase 3, randomized, double-blind, placebo-controlled studies of roxadustat for the treatment of anemia in patients with non–dialysis-dependent (NDD) CKD were assessed. Data from prespecified, clinically relevant patient subgroups were analyzed for: mean change from baseline (CFB) in hemoglobin (Hb) averaged over weeks 28–52 regardless of rescue therapy (primary US efficacy endpoint) and patients (%) that received rescue therapy in the first 52 weeks.

Results

Roxadustat- (n=2391) vs. placebo-treated patients (n=1886) achieved a significantly larger mean (SD) CFB in Hb level (1.85 [0.94] vs. 0.13 [1.01]), corresponding to a least-squares mean (LSM) difference of 1.72 (95% CI: 1.65, 1.79) (p<0.0001). The results of all subgroup analyses were consistent with those for both the primary US efficacy endpoint and the percentage of patients requiring rescue therapy in the overall NDD population (Table). Significantly fewer patients required rescue therapy during roxadustat treatment vs. placebo (8.9% vs. 31.1%), corresponding to a hazard ratio of 0.19 (95% CI: 0.16, 0.23) (p<0.0001). The effect was consistent in all subgroups and especially pronounced in patients with baseline Hb <8.0 g/dL (18.1% vs. 59.3%) and those with baseline eGFR <10.0 mL/min/1.73m2 (14.8% vs. 48.3%).

Conclusion

The efficacy of roxadustat vs. placebo for a larger mean CFB in Hb and fewer patients that received rescue therapy was consistent across a wide range of prespecified subgroups in the NDD-CKD population.

Funding

  • Commercial Support –