Abstract: TH-PO975
Efficacy and Safety of Roxadustat in Peritoneal Dialysis CKD: Pooled Analysis of Four Phase 3 Studies
Session Information
- Late-Breaking Clinical Trials (Posters)
November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 701 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Fliser, Danilo, Saarland University Medical Center and Saarland University, Homburg, Germany
- Bhandari, Sunil, Hull University Teaching Hospitals NHS Trust and Hull York Medical School, York, United Kingdom
- Ortiz, Alberto, Fundacion Jimenez Diaz, Madrid, Spain
- Santos, Vicki R., Astellas Pharma US Inc, Northbrook, Illinois, United States
- Jiletcovici, Alina, Astellas Pharma US Inc, Northbrook, Illinois, United States
- Akizawa, Tadao, Showa University School of Medicine, Tokyo, Japan
Background
Roxadustat is an oral HIF-PH inhibitor for anemia of CKD treatment. This pooled subgroup analysis examined the efficacy, need for transfusions, and safety of roxadustat compared with ESA in patients with anemia of CKD on peritoneal dialysis (PD) from the ALPINE studies, a large global phase 3 program.
Methods
Data from four multicenter, randomized, open-label studies comparing roxadustat to ESAs (epoetin alfa or darbepoetin alfa) in patients on PD were included in this pooled analysis (PYRENEES, SIERRAS, HIMALAYAS, ROCKIES). Hb target (g/dL) for roxadustat in all studies was 10.0-12.0, and ESA use followed local guidelines and labeling. Endpoints evaluated were Hb change from baseline to Weeks 28-36 (without rescue therapy, ie, RBC transfusion and/or ESA use), Hb change from baseline to Weeks 28-52 (regardless of rescue therapy), and time to rescue therapy. Safety and tolerability were assessed by treatment-emergent adverse events (TEAEs) from first study drug administration up to 28 days after the last dose. Nominal P-values are reported.
Results
In total, 422 patients were included (215 roxadustat, 207 ESA). Mean (SD) baseline Hb (g/dL) was 9.8 (1.2) for patients treated with roxadustat and 9.7 (1.2) for patients treated with ESA. Patients treated with roxadustat achieved a larger least-squares mean (LSM) change from baseline to Weeks 28-36 in Hb without rescue therapy versus ESA (roxadustat LSM: 1.38; 95% CI: 1.21-1.56; ESA LSM: 0.97; 95% CI: 0.78-1.16; LSM difference: 0.41; 95% CI: 0.16-0.67; P=0.0017) and Hb change from baseline to Weeks 28-52 regardless of rescue therapy (roxadustat LSM: 1.31; 95% CI: 1.15-1.47; ESA LSM: 1.00; 95% CI: 0.82-1.17; LSM difference: 0.32; 95% CI: 0.08-0.55; P=0.0077). Risk for RBC transfusion was reduced for patients treated with roxadustat versus ESA (HR: 0.49; 95% CI: 0.25-0.93; P=0.0304). The incidence rates per 100 patient-exposure years for overall TEAEs (56.5 vs 54.4), grade ≥3 TEAEs (27.7 vs 27.5), and serious TEAEs (37.2 vs 35.8) were similar in the roxadustat and the ESA treatment groups, respectively.
Conclusion
This pooled analysis demonstrates that roxadustat, an oral medication, corrected and maintained Hb levels in patients with anemia of CKD on PD similarly to ESAs with a comparable safety profile.
Funding
- Commercial Support –