Abstract: PO0256
Roxadustat Lowers Risk of Red Blood Cell Transfusion in Patients with Anemia of CKD
Session Information
- Anemia and Iron Management
October 22, 2020 | Location: On-Demand
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Fishbane, Steven, Northwell Health, Great Neck, New York, United States
- Provenzano, Robert, Wayne State University, Detroit, Michigan, United States
- Rastogi, Anjay, University of California Los Angeles, Los Angeles, California, United States
- Coyne, Daniel W., Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, United States
- Pecoits-Filho, Roberto, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
- Charytan, Chaim, Nephrology Associates, PC, New Rochelle, New York, United States
- Pola, Maksym, AstraZeneca, Warsaw, Poland
- Poole, Lona, FibroGen Inc, San Francisco, California, United States
- Saha, Gopal, FibroGen Inc, San Francisco, California, United States
- Chou, Willis, FibroGen Inc, San Francisco, California, United States
- Lee, Tyson T., FibroGen Inc, San Francisco, California, United States
- Yu, Kin-Hung Peony, FibroGen Inc, San Francisco, California, United States
Background
RBC transfusions may cause reactions, lead to allo-sensitization, or rarely transmit infections, so treatments reducing transfusions are desirable. This analysis assessed whether roxadustat, an oral hypoxia–inducible factor prolyl hydroxylase inhibitor, reduced the need for RBC transfusions in patients with non-dialysis-dependent (NDD) and dialysis-dependent (DD) chronic kidney disease (CKD) and anemia.
Methods
Data from six completed randomized Phase 3 studies (up to 4y duration) in patients with Stage 3–5 CKD, comparing roxadustat with placebo in NDD-CKD, and with epoetin alfa in DD-CKD were assessed. Risk of first RBC transfusion was evaluated in individual studies and within pooled NDD and DD populations.
Results
In total, 4277 patients with NDD-CKD were evaluated (2391 roxadustat; 1886 placebo). Mean ± SD baseline Hb was 9.10 ± 0.74 g/dL (roxadustat) and 9.10 ± 0.73 g/dL (placebo). The DD-CKD studies comprised 3857 patients (1929 roxadustat; 1928 epoetin alfa). Mean ± SD baseline Hb was 9.63 ± 1.30 g/dL (roxadustat) and 9.67 ± 1.30 (epoetin alfa). Roxadustat reduced the risk of RBC transfusion by 74% versus placebo in NDD patients and by 18% versus epoetin alfa in DD patients (Table 1).
Conclusion
Roxadustat markedly and significantly reduced the risk of RBC transfusion during anemia treatment compared with placebo in NDD CKD and, versus epoetin alfa in DD CKD in the pooled patient populations.
Table 1. Risk of RBC transfusion in NDD-CKD and DD-CKD patients treated with roxadustat compared with placebo or epoetin alfa - FAS
| NDD pool (N=4277) | ||||
| Study | HR (roxadustat vs placebo) | Risk reduction for roxadustat vs placebo | 95% CI | p- value |
| 001† (OLYMPUS) | 0.37 | −63% | 0.30, 0.44 | <0.001 |
| 060 (ANDES) | 0.26 | −74% | 0.17, 0.41 | <0.0001 |
| 608 (ALPS) | 0.34 | −66% | 0.21, 0.55 | <0.001 |
| Pooled | 0.26 | −74% | 0.21, 0.32 | <0.0001 |
| DD pool (N=3857) | ||||
| Study | HR (roxadustat vs epoetin alfa) | Risk reduction for roxadustat vs epoetin alfa | 95% CI | P value |
| 002 (ROCKIES) | 0.83 | -14% | (0.64, 1.07) | 0.151 |
| 064 (SIERRAS) | 0.67 | −33% | 0.47, 0.97 | 0.034 |
| 063 (HIMALAYAS)b | 1.26 | +26% | 0.79, 2.02 | 0.328 |
| Pooled | 0.82 | −18% | 0.679, 0.997 | 0.046 |
aFull analysis set. CI, confidence interval; CKD, chronic kidney disease; DD, dialysis-dependent; HR, hazard ratio; NDD, non-dialysis-dependent.
Funding
- Commercial Support – Fibrogen, Inc.; AstraZeneca plc; Astellas Pharma Inc.