4C-03 - Impact of Roxadustat Approval on Anemia Treatment Patterns in Chinese Patients with Chronic Kidney Disease

Background: Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, was approved for anemia treatment in chronic kidney disease (CKD) in China at the end of 2018. However, the impact of its approval on the patterns and trends of anemia treatment in Chinese CKD patients remains unclear.

Objectives: To assess the impact of roxadustat’s approval on use of other treatment options (erythropoietin (EPO), oral/intravenous iron, and blood transfusion), and evaluate hemoglobin (Hb) levels in treated patients.

Methods: This retrospective, multicenter study analyzed electronic medical records from seven tertiary hospitals in China. Adult patients with CKD stage III-V and anemia in 2018 and 2021 (before and after roxadustat approval) were included. Patients with malignancies, non-CKD anemia, or records in both periods were excluded. We analyzed treatment patterns and Hb levels using descriptive statistics, and compared treatment trends using multivariable logistic regression and interrupted time-series analysis (ITSA). Subgroup analyses were performed for dialysis and non-dialysis patients.

Results: A total of 17,606 patients (8,452 in 2018; 9,154 in 2021) were included (mean age: 60.5 ± 17.1 years; 42.0% female; 33.2% on dialysis). In 2018, 43.2%, 30.2%, 8.3%, and 3.4% of patients received EPO, oral iron, intravenous iron, and transfusion, respectively (overall treatment rate: 53.4%). In 2021, these rates were 31.2%, 26.9%, 7.7%, 3.4%, and 23.9% used roxadustat (overall 54.2%). In dialysis patients, the corresponding rates were 70.6%, 41.8%, 14.0%, and 3.7% (overall 77.6%) in 2018 and 60.5%, 38.0%, 15.0%, 3.5%, and 37.6% (overall 80.4%) in 2021; in non-dialysis patients, they were 28.1%, 22.7%, 5.1%, and 3.3% (overall 40.0%) in 2018 and 18.0%, 21.9%, 4.4%, 3.4%, and 17.7% (overall 42.3%) in 2021. The most common combination was EPO + oral iron. About 3.9% used both EPO and roxadustat.
Comparative analyses showed increased overall anemia treatment (OR=1.27, 95% CI: 1.18–1.37) and decreased EPO use (OR=0.63, 95% CI: 0.58–0.68) post-approval, with no significant changes in iron or transfusion use. Similar results were found with ITSA. Subgroup analysis showed reduced oral iron use in dialysis patients (OR=0.81, 95% CI: 0.72–0.91) but increased use in non-dialysis patients (OR=1.11, 95% CI: 1.00–1.23). Among treated patients, mean Hb (SD) was 98.9 ± 19.8 g/L in 2018 (37.7% >110 g/L) and 99.2 ± 21.7 g/L in 2021 (41.3% >110 g/L).

Conclusions: The introduction of roxadustat has influenced anemia treatment practices among CKD patients in China, primarily replacing EPO. However, the increase in total treatment and Hb target achievement rates remained suboptimal. Off-label roxadustat-EPO combination was rare but warrants further attention and investigation.