Abstract: PO0267
Ophthalmological Effects of Roxadustat in the Treatment of Anemia in Dialysis-Dependent and Non-Dialysis-Dependent CKD Patients: Findings from Two Phase 3 Studies
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
- Nguyen, Quan Dong, Byers Eye Institute, Stanford School of Medicine, Stanford, California, United States
- Sepah, Yasir J., Byers Eye Institute, Stanford School of Medicine, Stanford, California, United States
- Yamaguchi, Yusuke, Astellas Pharma, Inc., Tokyo, Japan
- Otsuka, Tetsuro, Astellas Pharma, Inc., Tokyo, Japan
- Majikawa, Yoshikatsu, Astellas Pharma, Inc., Tokyo, Japan
- Reusch, Michael, Astellas Pharma Europe B.V., Leiden, Netherlands
- Akizawa, Tadao, Showa University School of Medicine, Tokyo, Japan
Background
Roxadustat is an orally active hypoxia-inducible factor prolyl hydroxylase inhibitor in late-stage development for the treatment of chronic kidney disease (CKD) anemia. Nonclinical data had suggested that hypoxia-inducible factor stabilization may promote angiogenesis, increasing the risk of retinal pathologies. We herein report the 24-week ophthalmological findings from two phase 3 studies of roxadustat in Japan.
Methods
Dialysis-dependent (DD) and non–dialysis-dependent (NDD) CKD patients (pts) with anemia were randomized to roxadustat (three times weekly) or darbepoetin alfa (DA; once weekly [DD]; once every two weeks [NDD]). Doses were titrated to maintain target hemoglobin. Ophthalmological assessments (funduscopic photograph, optical coherence tomography) were performed by centralized grading; visual acuity was assessed locally.
Results
A total of 302 DD pts (150, roxadustat; 152, DA) and 262 NDD pts (131, roxadustat; 131, DA) were randomized and received ≥1 dose of study drug. Results from the ophthalmological funduscopic photograph assessments are reported in Table 1. No meaningful changes occurred in visual acuity or retinal thickness in the treatment groups of either study.
Conclusion
In DD and NDD CKD pts with anemia, the risk of developing ophthalmic abnormalities was comparable between roxadustat and DA.
Ophthalmological Assessments
| Dialysis-Dependent | Non-Dialysis-Dependent | |||
| Parameter | Roxadustat | Darbepoetin | Roxadustat | Darbepoetin |
| Pts with previous or concurrent retinal vascular disorders at baseline | 62/150 (41.3%) | 57/152 (37.5%) | 64/130 (49.2%) | 63/131 (48.1%) |
| Pts with new or worsening retinal hemorrhagesa during 24-week treatment period | 46/142 (32.4%) | 53/145 (36.6%) | 38/121 (31.4%) | 51/128 (39.8%) |
| Pts with new retinal hemorrhages in pts with no retinal hemorrhage at baseline | 18/94 (19.1%) | 24/96 (25.0%) | 8/62 (12.9%) | 18/72 (25.0%) |
| Pts with new or worsening retinal hemorrhagesa in pts with ≥1 retinal hemorrhage at baseline | 28/48 (58.3%) | 29/49 (59.2%) | 30/59 (50.8%) | 33/56 (58.9%) |
a Any evidence of retinal hemorrhage, from “No” at baseline to “Yes,” and/or an increase from baseline in the total number of retinal hemorrhages.
Funding
- Commercial Support – Astellas Pharma, Inc.