The efficacy and safety of low-dose roxadustat in combination with recombinant human erythropoietin for treating hemodialysis patients with moderate anemia: A retrospective cohort study.

Abstract

Background: To evaluate the safety and efficacy of low-dose roxadustat combined with low-dose recombinant human erythropoietin (rhEPO) for the treatment of renal anemia in hemodialysis patients.

Materials and methods: We retrospectively reviewed the medical records of hemodialysis patients with moderate renal anemia between December 2019 and July 2023 from two medical centers. Patients were classified into 3 groups: rhEPO (150 - 300 IU/kg/week), roxadustat (1.5 - 2.5 mg/kg thrice weekly), and combination therapy (low-dose (≤ 1.5 mg/kg thrice weekly) roxadustat in addition to low-dose (≤ 150 IU/kg per week) rhEPO. After 24 weeks of treatment, the efficacy therapeutic endpoints and the safety endpoints were evaluated.

Results: Overall, a total of 158 patients were included: 53 in the rhEPO group, 52 in the roxadustat group, and 53 in the combination group. The median time to achieve Hb response in the combination therapy group was 20 days, which was shorter than that in the roxadustat group (20 vs. 25.5 days, log-rank p = 0.027) and the rhEPO group (20 vs. 27 days, log-rank p = 0.004). The mean rate of increase in Hb (g/L/month) during the first month of the treatment period was significantly greater in the combination group than in the roxadustat group (15.4 ± 4.7 vs. 11.1 ± 5.7, p = 0.038) or in the rhEPO group (15.4 ± 4.7 vs. 10.5 ± 4.3, p = 0.026). The incidence and frequency of adverse events were similar among the 3 groups.

Conclusion: The combination of low-dose roxadustat and rhEPO appears to have better effects in treating hemodialysis patients with moderate anemia by shortening the hemoglobin response time with minimal adverse effects.