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Abstract: TH-OR09

Adverse Event Rates Are Higher Post-Transfusion vs. Overall Follow-up and Independent of Background Anemia Treatment in Patients with CKD

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Provenzano, Robert, Wayne State University, Detroit, Michigan, United States
  • Pollock, Carol A., The University of Sydney, Sydney, New South Wales, Australia
  • 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
  • Lai, Rachel, FibroGen Inc, San Francisco, California, United States
  • Zhong, Ming, FibroGen Inc, San Francisco, California, United States
  • Szczech, Lynda, FibroGen Inc, San Francisco, California, United States
Background

The use of transfusion can treat anemia in the short term but may increase the risk of adverse events. Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and improves iron metabolism. Roxadustat has been shown to decrease the need for transfusions in patients with chronic kidney disease (CKD).

Methods

Data were pooled from three pivotal, phase 3 studies of roxadustat vs. placebo in patients with non-dialysis-dependent (NDD) CKD and three pivotal phase 3 studies of roxadustat vs. epoetin alfa in patients with dialysis-dependent (DD) CKD. We evaluated rates of intravascular volume-related adverse events (AEs; reported from a predefined list [heart failure, pulmonary edema, respiratory failure] as a direct cause of excess intravascular volume or as a potential symptom) and treatment-emergent adverse events (TEAEs) during the 14-day post-transfusion period and the overall follow-up period (last dose + 28 days) in patients who had ≥1 transfusion.

Results

Intravascular volume-related AE and TEAE rates were at least 9-fold higher during the 14-day post-transfusion period vs. the overall follow-up period across all subgroups (Table). Trends in overall TEAE rates were similar across treatment groups.

Conclusion

Intravascular volume-related AEs occurred at higher rates post-transfusion across all populations. The reduction in transfusions for patients taking roxadustat could lower patient risk and healthcare resource use in managing CKD-related anemia.

Funding

  • Commercial Support