Abstract: PO0450
Efficacy and Safety of Roxadustat in Patients with Anemia of Dialysis-Dependent CKD (DD-CKD) Treated Continuously for ≥3 Years
Session Information
- Anemia: Therapies and Iron Metabolism
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Hao, Chuan-Ming, Huashan Hospital Fudan University, Shanghai, China
- Dahl, Neera K., Yale University School of Medicine, New Haven, Connecticut, United States
- Tham, Stefan, Clinical Research, AstraZeneca, Gothenburg, Sweden
- Orias, Marcelo, Yale University School of Medicine, New Haven, Connecticut, United States
- Pecoits-Filho, Roberto, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
Background
Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is in development in the US for chronic treatment of anemia of CKD. This pooled post hoc analysis explored outcomes in DD-CKD patients (pts) treated with roxadustat for ≥3 years (y).
Methods
Pts were randomized to open-label roxadustat (n=1943) or epoetin alfa (EPO; n=1947) for up to 4y in 3 Phase 3 DD-CKD trials (ROCKIES, SIERRAS, HIMALAYAS). Intravenous iron was given per local care for EPO and limited to need for roxadustat. Data were analyzed in pts treated continuously for ≥3y, regardless of rescue therapy use. P values are exploratory. Adverse events (AEs) were assessed.
Results
Overall, 288 roxadustat and 360 EPO pts were treated for ≥3y; of these, 95% and 94% completed treatment. Baseline (BL) values for roxadustat vs EPO were generally balanced: mean age 55 vs 57y, mean hemoglobin (Hb) 9.8 vs 9.7 g/dL, dialysis modality was predominantly hemodialysis (94% vs 93% pts), median dialysis vintage 21.9 vs 17.4 months. Over Weeks (wk) 28–52, change in Hb from BL was greater with roxadustat vs EPO (+1.3 vs +1.0 g/dL; P<0.001) and proportion of pts with Hb ≥10 g/dL was higher (95% vs 85%). To wk 156, roxadustat maintained higher Hb vs EPO, with 11% increase in mean roxadustat weekly dose from wk 25–28 vs 20% increase in mean EPO weekly dose (Figure). Need for red blood cell (RBC) transfusion appeared less with roxadustat vs EPO (11% vs 16% pts). Serious AE rates with roxadustat vs EPO were 18.0 vs 16.9 per 100 pt-exposure years, respectively.
Conclusion
In DD-CKD pts who remained on treatment for ≥3y, Hb stability with roxadustat was achieved with minimal dose change and less need for RBC transfusion vs EPO. Safety was comparable with roxadustat vs EPO.
Funding
- Commercial Support –