Efficacy and safety of roxadustat for anaemia in dialysis-dependent and non-dialysis-dependent chronic kidney disease patients: A systematic review and meta-analysis.

AIMS: Renal anaemia is a common complication of chronic kidney disease (CKD). Roxadustat is the first-in-class oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anaemia. In this systematic review, we aimed to investigate the efficacy and safety of roxadustat in the treatment of anaemia in CKD patients.

METHODS

PubMed, Cochrane Library, Embase, and ClinicalTrials.gov databases were searched from their inception to February 2021 for randomised controlled trials (RCTs) that compared the efficacy and safety of roxadustat to those of an erythropoiesis-stimulating agent (ESA) or a placebo in treating anaemia in CKD patients.

RESULTS

Nine RCTs involving 2743 patients were found. The meta-analysis showed that roxadustat increased haemoglobin (Hb) level by 0.91 g/dL (95% confidence interval [CI]: 0.47-1.34, P < .05), transferrin level by 0.50 mg/dL (95% CI: 0.34-0.65, P < .05), and total iron-binding capacity by 50.64 μg/dL (95% CI: 36.21-65.07, P < .05) in CKD patients. Decreases in hepcidin (mean difference [MD] = -23.16, 95% CI: -37.12 to -9.19, P < .05) and ferritin (MD = -38.35, 95% CI: -67.41 to -9.29, P < .05) levels were also observed. There was no significant difference in the incidence of adverse events (AEs) (OR: 1.12, 95% CI: 0.95-1.32, P = .17) between the roxadustat and control groups; however, the incidence of serious AEs in the roxadustat group was significantly higher than that in the ESA group (OR: 1.33, 95% CI: 1.06-1.68, P < .05).

CONCLUSION

Roxadustat can significantly improve renal anaemia in CKD patients by increasing Hb level and iron metabolism. However, attention must be paid to the risk of SAEs during treatment.