Roxadustat proven safe, effective for anaemia in CKD patients

Treatment with roxadustat leads to significant improvements in renal anaemia among patients with chronic kidney disease (CKD) by increasing haemoglobin (Hb) level and iron metabolism, according to a recent study. However, the risk of serious adverse events (AEs) during treatment must be considered.

This systematic review sought to examine the efficacy and safety of roxadustat in the treatment of anaemia in CKD patients. The investigators searched the databases of PubMed, Embase, Cochrane Library, and ClinicalTrials.gov from inception to February 2021. Randomized controlled trials (RCTs) that compared the efficacy and safety of roxadustat to those of an erythropoiesis-stimulating agent (ESA) or a placebo were identified.

Nine RCTs, including a total of 2,743 patients, were eligible for the meta-analysis, which revealed that roxadustat use resulted in increased Hb level by 0.91 g/dL (95 percent confidence interval [CI], 0.47‒1.34; p<0.05), transferrin level by 0.50 mg/dL (95 percent CI, 0.34‒0.65; p<0.05), and total iron-binding capacity by 50.64 μg/dL (95 percent CI, 36.21‒65.07; p<0.05) in CKD patients.

There were also decreases in levels of hepcidin (mean difference [MD], ‒23.16, 95 percent CI, ‒37.12 to ‒9.19; p<0.05) and ferritin (MD, 38.35, 95 percent CI, ‒67.41 to ‒9.29; p<0.05).

No significant between-group difference was observed in the incidence of AEs (OR, 1.12, 95 percent CI, 0.95‒1.32; p=0.17), but the incidence of serious AEs was significantly higher in the roxadustat group than that in the ESA group (OR, 1.33, 95 percent CI, 1.06‒1.68; p<0.05).

“Renal anaemia is a common complication of CKD,” the investigators said. “Roxadustat is the first-in-class oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anaemia.”