Correlation between blood concentration of roxadustat and clinical efficacy in patients with anemia of chronic kidney disease

Abstract

Roxadustat has been associated with the efficacy and safety in patients with chronic kidney disease-related anemia. However, the relationship between roxadustat blood concentration and clinical efficacy is lacking. To explore of the correlation between clinical efficacy and blood concentration of roxadustat in patients with renal anemia of chronic kidney diseases, so as to provide reference for rational clinical drug use. A total of 46 patients were selected with a diagnosis of renal anemia who were prescribed roxadustat at the department of nephrology of the First Hospital of Hebei Medical University from December 2019 to March 2020. The roxadustat blood concentration was determined at 12 weeks of treatment, according to the cumulative response rate, patients were divided into the response group and the nonresponse group, and the relationship between roxadustat blood concentration and treatment effect was analyzed. We also explored the correlation between various factors and the blood concentration. The patients in the response group had higher roxadustat blood concentrations than the nonresponse group ( P < .05), and there was no correlation between blood concentration and clinical characteristics such as age, gender, and dosage ( P > .05). The blood concentration of roxadustat was correlated with clinical efficacy. The higher the blood concentration, the better the clinical efficacy, meaning it might be a predictor of efficacy.

Influencing factors of clinical efficacy of roxadustat among hemodialysis patients

“…Zhang et al. [ 20 ] revealed that the blood concentration of roxadustat was correlated with the clinical efficacy in patients undergoing maintenance hemodialysis, which was consistent with our study. The study included patients who were exposed to roxadustat for the first time, and the response was defined as a change in Hb from baseline of ≥10 g/L, which was different from our study.…”

“…In our study, the SF level and the percentage of patients receiving oral iron therapy was higher in the response group than in the nonresponse group, without a significant difference. However, no significant correlation was found between these variables and clinical efficacy, consistent with a previous study [ 20 ]. What should be noted was that, even though without a significant difference, the levels of ferritin in the nonresponse group were two times lower than in the response group, which may contribute to the poor response to roxadustat, especially if patients in non-response group also had functional iron deficiency.…”

Isoquinoline‐based intrinsic fluorescence assessment of erythropoiesis‐stimulating agent, Roxadustat (FG‐4592), in tablets: applications to content uniformity and human plasma evaluation

“…The results showed that even the proposed method was less sensitive than the reported methods compared with which it was simpler and required fewer steps. Moreover, its analysis range was acceptable for the determination of ROX in clinical pharmacokinetics, as indicated by its range in healthy patients (with a real range 10–36 μg/ml) [12, 13] and those with CKD (with a real range 109–16.800 ng/ml) [14].…”

“…Following oral administration in healthy people, the pharmacokinetics of ROX are well defined, with 99% plasma binding, the concentration at half‐maximum effect of 10–36 μg/ml, and elimination t ½ of 9.6–16 h [12]. Additionally, in a study examining the connection between ROX blood concentration and clinical efficacy in individuals with CKD anaemia, the average blood concentration of ROX was 3327.96 ± 4454.04 ng/ml (with a range 109–16.800 ng/ml) after the drug was taken orally three times a week at a dosage of 100 mg for 46 patients weighing 45–60 kg and 120 mg for patients with CKD weighing > 60 kg [14].…”