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Abstract: PO0268

Risk of Transfusion in Patients with Dialysis-Dependent CKD Increases with Hemoglobin Levels <10 g/dL vs. ≥10 g/dL: Pooled Results from Roxadustat Phase 3 Studies

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Provenzano, Robert, Wayne State University, Detroit, Michigan, United States
  • Pecoits-Filho, Roberto, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
  • Rastogi, Anjay, University of California Los Angeles, Los Angeles, California, United States
  • Leong, Robert, FibroGen Inc, San Francisco, California, United States
  • Saikali, Khalil Georges, FibroGen Inc, San Francisco, California, United States
  • Pola, Maksym, AstraZeneca, Warsaw, Poland
  • Little, Dustin J., FibroGen Inc, San Francisco, California, United States
  • Yu, Kin-Hung Peony, FibroGen Inc, San Francisco, California, United States
Background

Roxadustat is a novel, orally bioavailable, heterocyclic small molecule that reversibly inhibits hypoxia-inducible factor (HIF) prolyl hydroxylase enzymes and activates HIF and transcription of HIF-responsive genes, including erythropoietin. In patients with ESRD, the risk for blood/RBC transfusion is higher in patients with hemoglobin (Hb) levels <10 g/dL vs. those with Hb ≥10 g/dL. We evaluated the efficacy of roxadustat vs. epoetin alfa on blood/RBC transfusion by Hb level in US-based patients with dialysis-dependent (DD) CKD.

Methods

Data from three pivotal phase 3, randomized, active-controlled studies of roxadustat for the treatment of anemia in DD patients were assessed. Patients were randomized to receive roxadustat or epoetin alfa with periodic dose evaluation/titration. Transfusion was allowed at any time if it was deemed a medical necessity by the Investigator. The incidence rate of transfusion was calculated based on Hb level categorized as: <8.0, 8 to <10, and ≥10 g/dL. Data were evaluated for the on-treatment period + 28 days after the last dose of study drug.

Results

In the overall pooled population of patients with DD-CKD, roxadustat vs. epoetin alfa reduced the risk for transfusion by 18% (HR, 0.82 [95% CI: 0.68, 1.00]; p=0.0461). When patient-exposure data were stratified by achieved Hb level, the risk for transfusion increased as Hb levels decreased (Table). The incidence rate of transfusion increased approximately 5-fold in patients with Hb <10 g/dL vs. those with Hb ≥10 g/dL.

Conclusion

In US-based patients with DD-CKD and anemia treated with roxadustat, the risk for transfusion was approximately 5 times higher in patients with Hb <10 g/dL vs. those with Hb ≥10 g/dL, regardless of treatment arm.

Table: Incidence rate of transfusion (events/100 PEY) based on Hb level and treatment group
 Roxadustat (n=874)Epoetin alfa (n=879)
Hb (g/dL)EventsPEYTransfusion Rate*% of PEYEventsPEYTransfusion Rate*% of PEY
≥10.0721166.96.279.01341208.811.169.3
8.0 to <10.093288.132.319.5160507.831.529.1
<8.05122.4227.71.55728.2202.11.6
Total2161477.414.6100.03511744.920.1100.0

*Number of events per 100 PEY; Hb, hemoglobin; PEY, patient-exposure years

Funding

  • Commercial Support