Abstract: PO0258
Health-Related Quality of Life in Roxadustat-Treated Patients with Anemia and Non-Dialysis-Dependent 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
- Coyne, Daniel W., Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, United States
- Manllo-Karim, Roberto, South Texas Kidney Specialists, P.A., McAllen, Texas, United States
- Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States
- Pollock, Carol A., The University of Sydney, Sydney, New South Wales, Australia
- Pecoits-Filho, Roberto, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
- Lee, Tyson T., FibroGen Inc, San Francisco, California, United States
- Hardy, Elise, AstraZeneca, Gaithersburg, Maryland, United States
- Yu, Kin-Hung Peony, FibroGen Inc, San Francisco, California, United States
Background
Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and improves iron metabolism. Anemia in CKD impacts health-related quality of life (HRQL) by reducing physical capacity and energy levels. Studies have demonstrated a direct relationship between HRQL scores and hemoglobin (Hb) levels in non–dialysis-dependent (NDD) and dialysis-dependent patients with CKD. We assessed the impact of roxadustat on HRQL in patients with NDD-CKD.
Methods
Pooled data from three pivotal, phase 3, randomized, double-blind, placebo-controlled studies of roxadustat for the treatment of anemia in patients with NDD-CKD were assessed. Patients with data up to the time of dialysis treatment and who had pretreatment and ≥1 post-treatment HRQL measurement were included. Mean changes from baseline to Week 12 in HRQL scores were compared between the treatment groups.
Results
Least-squares mean treatment differences favored the roxadustat group at Week 12 (all p-values <0.05) in the majority of measures analyzed (Table). Between-group differences were larger in subgroups with lower (ie, worse) baseline scores.
Conclusion
Roxadustat demonstrated improvement in most HRQL measures vs. placebo in patients with NDD-CKD.
Funding
- Commercial Support – Fibrogen, Inc.; AstraZeneca plc; Astellas Pharma Inc.