The efficacy and safety of roxadustat in anemia treatment in hemodialysis patients with erythropoietin-hyporesponsiveness

Abstract

BackgroundErythropoietin is an important drug for the treatment of anemia in hemodialysis patients. However, many patients show erythropoietin-hyporesponsiveness. Roxadustat has been shown to be effective in treating patients with anemia due to chronic kidney disease. However, its efficacy and safety in hemodialysis patients with erythropoietin-hyporesponsive anemia remain unclear.MethodsErythropoietin-hyporesponsiveness was defined as erythropoietin dose of more than 450U/kg intravenously or 300U/kg subcutaneously for 16 weeks, with hemoglobin rising rate below 1 g/dL/month or 11.0 g/dL. A cohort of hemodialysis patients with anemia and a low response to erythropoietin from January 2020 to December 2020 were treated with roxadustat for 12 weeks to observe changes in hemoglobin, iron metabolism, blood lipid, and inflammatory indicators and to evaluate the safety and efficacy of roxadustat.ResultsThere were 56 patients with erythropoietin-hyporesponsiveness, and a total of 44 patients (78.6%) completed the 12-week follow-up, including 16 males (36.4%); patient ages were 54.6±14.2 years. The mean initial treatment dose of roxadustat was 104.4±12.4 mg thrice a week. At week 12, 30 subjects (68.2%) met the protocol-defined primary efficacy endpoint. After 12 weeks of treatment, hemoglobin was significantly increased from 7.81±1.36 g/dL to 9.80±1.94 g/dL (P<0.001), serum ferritin, serum total cholesterol and triglyceride were significantly decreased. While white blood cells and neutrophils significantly increased than baseline.ConclusionThis study indicated that roxadustat significantly increases hemoglobin levels, improving iron absorption and utilization, reducing cholesterol and triglyceride levels, with good short-term safety profile in hemodialysis patients with erythropoietin-hyporesponsive anemia.