Communication Dans Un Congrès Année : 2025

#693 Hospitalization for congestive heart failure following treatment with roxadustat in patients with or without a history of CHF: pooled post hoc analysis of phase 3 studies

Résumé

Background and Aims Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, is approved in multiple countries for the treatment of anemia of chronic kidney disease (CKD). Previous pooled analyses have reported that roxadustat was non-inferior to erythropoiesis-stimulated agents (ESAs) for time to first major adverse cardiovascular event (MACE) and MACE plus congestive heart failure (CHF) or unstable angina requiring hospitalization in patients with dialysis-dependent (DD) or non–dialysis-dependent (NDD) CKD; however, these analyses were not stratified by history of CHF. The current post hoc analysis was conducted to evaluate time to first hospitalization for CHF in patients with DD or NDD CKD with or without a history of CHF treated with roxadustat compared with ESA. Method Patients with anemia of CKD from four phase 3, multicenter, randomized, open-label, active-comparator studies (HIMALAYAS, ROCKIES, SIERRAS, and PYRENEES) were pooled for the DD CKD group, and patients from a phase 3, multicenter, randomized, open-label, active-comparator study (DOLOMITES) were analyzed as the NDD CKD group. Data were analyzed for the time to first occurrence of hospitalization for CHF during and up to 7 days after the treatment period (ie, on-treatment plus 7 days) using a separate model for each of the four groups (DD CKD with a history of CHF, DD CKD without a history of CHF, NDD CKD with a history of CHF, and NDD CKD without a history of CHF). Hazard ratios (HRs) were estimated with a Cox proportional hazards model adjusted for baseline age as a continuous covariate. The non-inferiority margin was set at 1.8, as recommended by industry guidance provided by health authority bodies regarding the assessment of cardiovascular risk in clinical studies. Results Of the 4714 patients with DD CKD (roxadustat: n = 2354; ESA: n = 2360), 1122 had a history of CHF (roxadustat: n = 562; ESA: n = 560). Of the 616 patients with NDD CKD (roxadustat: n = 323; ESA: n = 293), 158 had a history of CHF (roxadustat: n = 81; ESA: n = 77). In the DD CKD group, treatment with roxadustat demonstrated noninferiority to ESA treatment in patients with no history of CHF (HR [95% CI]: 0.85 [0.64, 1.14]) and in patients with a history of CHF (0.97 [0.67, 1.39]; Table 1), both with the upper limit of the confidence limit less than the non-inferiority margin of 1.8. In the NDD CKD group, treatment with roxadustat demonstrated noninferiority to ESA treatment in patients with a history of CHF (0.62 [0.25, 1.51]). The noninferiority margin was not achieved (upper limit of the confidence interval ≥1.8) in patients with NDD CKD with no history of CHF (1.31 [0.57, 2.99]; Table 1). These results are difficult to interpret due to the low number of events included in the analysis; this increased uncertainty is evident in the wider confidence interval. Conclusion In patients with DD CKD, regardless of history of CHF, and in patients with NDD CKD with a history of CHF, the results from this post hoc analysis suggest that treatment with roxadustat is non-inferior to ESA for the risk of hospitalization for CHF. In patients with NDD CKD without a history of heart failure, the results should be interpreted cautiously due to the low number of events included in this analysis.

Dates et versions

hal-05442140 , version 1 (05-01-2026)

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Citer

Gabriel Choukroun, Alina Jiletcovici, Arianne Schild, Ernesto Paoletti. #693 Hospitalization for congestive heart failure following treatment with roxadustat in patients with or without a history of CHF: pooled post hoc analysis of phase 3 studies. 62nd ERA Congress, 4-7 June 2025, European Renal Association, Jun 2025, Vienna (Austria), Austria. pp.Meeting Abstract 693, ⟨10.1093/ndt/gfaf116.067⟩. ⟨hal-05442140⟩

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