Abstract: PO0455
Roxadustat in Elderly Patients with Anemia of CKD
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
- Pollock, Carol A., University of Sydney, Sydney, New South Wales, Australia
- Provenzano, Robert, Wayne State University, Detroit, Michigan, United States
- Rastogi, Anjay, UCLA, Los Angeles, California, United States
- Pecoits-Filho, Roberto, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
- Liu, Cameron S., FibroGen, San Francisco, California, United States
- Szczech, Lynda, FibroGen, San Francisco, California, United States
Background
Elderly patients with anemia of chronic kidney disease (CKD) typically have several comorbidities requiring polypharmacy, but slower drug metabolism than younger patients. Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that promotes coordinated erythropoiesis and increased iron availability. We explored roxadustat treatment in elderly (≥65 years) vs younger (<65 years) patients in dialysis-dependent- (DD) and non-dialysis-dependent-(NDD) CKD populations.
Methods
Data were pooled from pivotal phase 3 studies of roxadustat vs placebo (stage 3-5 NDD-CKD) and vs epoetin alfa (DD-CKD). Data were analyzed for patients <65 and ≥65 years old. The primary endpoint in the overall trials was mean change from baseline (CFB) in hemoglobin (Hb), weeks 28-52, regardless of rescue therapy. Least square mean difference (LSMD) was determined between treatments. Secondary endpoints were transfusion rate per 100 patient-exposure years (NDD and DD) and change in mean IV iron use (DD). Adverse events were monitored during treatment + 28 days post treatment (NDD and DD).
Results
In NDD (N=4277) and DD (N=3590) populations, the majority were female (NDD) or male (DD) (Table). Baseline Hb levels were higher in elderly vs younger patients (Table). Age did not affect improvements in Hb, but mean CFB was greater in elderly vs younger in DD and NDD patients (Table). Transfusion rates were lower in younger vs elderly DD patients and in elderly vs younger NDD patients (Table). Trends in mean IV iron use were lower with roxadustat vs epoetin alfa and similar among age groups (Table). Roxadustat was well tolerated, regardless of age (Table).
Conclusion
Roxadustat was effective and well tolerated, regardless of age, in patients with anemia of CKD.
Funding
- Commercial Support –