SHORT-TERM EFFICACY AND LONG-TERM FOLLOW-UP OBSERVATION OF ROXADUSTAT IN TREATING RENAL ANEMIA iN ELDERLY PATITENTS WITH NDD-CKD

To retrospectively observe the short-term efficacy and long-term follow-up changes in elderly NDD-CKD patients with renal anemia prescribed roxadustat.

Patients aged ≥60 years with NDD-CKD stages 3-5 who were treated with roxadustat in the nephrology department of Beijing Hospital (outpatient or inpatient) from October 1, 2020, to February 28, 2023, were included and followed up until December 31, 2024. Changes in hemoglobin and hemoglobin response rates at week 4 and week 12 after drug administration were observed. Hemoglobin levels of 110-130 g/L were considered as reaching the target value. A hemoglobin increase of ≥ 10g/L in four weeks is defined as early hemoglobin response.Hemoglobin levels, achievement rates, and roxadustat doses at the end of follow-up were observed. Lipid changes in patients using atorvastatin and outcomes of all patients, including major clinical events, were also observed.

A total of 67 NDD-CKD stages 3-5 patients were included, with a mean age of 75.3±9.0 years. Baseline serum creatinine was 239.1±128.4 μmol/L, and eGFR (CKD-EPI) was 24.7±15.6 ml/min. CKD stage 4 and 5 accounted for 37.3% and 32.8%, respectively. Baseline hemoglobin was 95.6±10.6 g/L (n=67). Hemoglobin levels gradually increased to 109.86±10.0 g/L (n= 54, P<0.001) at week 4 and 115.7±13.6 g/L (n=51, P<0.001) at week 12. The proportion of CKD stage 5 in the non-early responder group is higher than in the early responder group.A total of 55 patients were followed up to the endpoint, with a follow-up time of 86.7±55.6 (13.0, 199.7) weeks. Hemoglobin increased to 114.2±9.3g/L (P<0.001), the percentage of Hb≥100g/L was 96.4%, and that of Hb≥110g/L was 69.1%. The weekly dose of roxadustat increased from 171.1±63.0mg to 202.2±108.8mg (P=0.049). Follow-up outcomes of patients: 14 patients were lost to follow-up (25.5%). Except for 4 patients (7.3%) who switched to EPO due to economic reasons or new-onset dysphagia and 1 patient (1.8%) who died from the primary disease, the remaining patients included 5 cases (9%) who discontinued medication after improvement, 15 cases (27.3%) who entered hemodialysis or peritoneal dialysis, and 16 cases (29.1%) who continued medication until the end of follow-up. The combination of roxadustat and torvastatin resulted in a decrease in total cholesterol and low-density lipoprotein cholesterol in patients (P=0.001 and P=0.014), while the group treated with oxadustat alone without statins showed no changes in lipid levels. Among 7 patients with type 2 diabetes and CKD, 11 major clinical events occurred: 2 cases of lower extremity venous thrombosis, 1 case of cerebral infarction, 1 case of community-acquired pneumonia, 2 cases of heart failure after COVID-19 infection (one of whom was the same patient as the cerebral infarction case), 4 episodes of heart failure after community-acquired pneumonia in the same patient, and 1 case of acute myocardial infarction secondary to pneumonia combined with ketoacidosis.

Roxadustat can be prescribed to improve the hemoglobin levels of most elderly NDD-CKD patients in both short-term treatment and long-term follow-up. The combination of roxadustat and atorvastatin can further reduce blood cholesterol and low-density lipoprotein levels. For CKD stage 5 patients, increasing the initial dose by one step may help achieve early hemoglobin targets. Elderly patients need enhanced monitoring to avoid large fluctuations in hemoglobin levels.