Roxadustat for Erythropoiesis-Stimulating Agent Hyporesponsive Anemia in Hemodialysis: Multicenter Retrospective Analysis

TL;DR

This study examines the effectiveness of Roxadustat in treating anemia in hemodialysis patients who don't respond well to traditional treatments.

Contribution

The study provides real-world evidence on Roxadustat's impact on anemia in ESA-hyporesponsive hemodialysis patients.

Findings

Roxadustat significantly increased hemoglobin levels in ESA-hyporesponsive patients over six months.

Baseline hemoglobin levels predicted final hemoglobin levels, regardless of treatment group.

Transfusion requirements decreased in both treatment groups over the study period.

Abstract

Background and Objectives: Anemia management in maintenance hemodialysis patients with erythropoiesis-stimulating agent (ESA) hyporesponsiveness remains challenging. Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, offers a mechanistically distinct alternative. Materials and Methods: This multicenter retrospective study analyzed 110 hemodialysis patients with persistent anemia (Hemoglobin (Hb) < 10 g/dL) despite ≥ 3 months of maximum-reimbursable-dose ESA therapy in Türkiye. Outcomes were evaluated between patients who switched to Roxadustat (n = 80) and those who continued ESA therapy (n = 30) over 6 months in a non-randomized, observational comparison. Results: At baseline, median Hb levels were significantly lower in the Roxadustat-group than in the ESA-group (8.70 vs. 9.50 g/dL; p < 0.001), while weight-adjusted ESA doses were comparable (p = 0.332). By Month 6, the Roxadustat group achieved a significant Hb increase (from 8.70 to 9.95 g/dL), whereas the ESA-group showed no significant change (9.50 to 9.65 g/dL), and end-of-treatment Hb did not differ significantly between groups. The unadjusted mean Hb rise was greater in the Roxadustat cohort than in the ESA cohort (+1.40 ± 1.55 vs. +0.65 ± 1.93 g/dL; p = 0.037). However, after adjustment for baseline Hb (ANCOVA), baseline Hb predicted final Hb, while treatment group was not independently associated with final Hb. Transfusion requirements declined over follow-up in both groups. No new short-term safety signal was identified based on available clinical documentation. Conclusions: Roxadustat improved Hb in ESA-hyporesponsive patients with lower baseline Hb, but adjusted analyses indicated that baseline severity influenced response. Targets were not consistently achieved; these findings are hypothesis-generating regarding dose optimization, treatment duration, and earlier initiation.

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