Hb target achievement and associated predictors of roxadustat therapy across baseline anemia severities in maintenance hemodialysis: A single-center real-world retrospective cohort study

BACKGROUND: Anemia is common in maintenance hemodialysis (MHD). Therapy with erythropoiesis-stimulating agents (ESAs) may be limited by inflammation-related hyporesponsiveness and safety concerns. Real-world evidence on roxadustat across baseline anemia severities is limited. MATERIALS AND METHODS: In this single-center retrospective cohort, 300 MHD patients who switched from ESAs to roxadustat monotherapy were grouped by baseline hemoglobin (Hb): severe < 80 g/L (n = 82), moderate 80 - 99 g/L (n = 137), and mild 100 - 110 g/L (n = 81). The primary outcome was sustained Hb target achievement (100 - 120 g/L for ≥ 2 consecutive visits within 12 weeks without rescue therapy). Hb trajectories were assessed using linear mixed-effects models, and predictors of target achievement were identified by multivariable logistic regression with false discovery rate adjustment. RESULTS: At 12 weeks, sustained Hb achievement increased with baseline Hb: 46.3% (severe), 64.2% (moderate), and 76.5% (mild) (q = 0.0012). Hb variability decreased across groups (time-weighted coefficients of variation 7.5, 6.1, and 5.2%; q = 0.008). Early Hb rise was fastest in severe anemia (+1.85 vs. +1.24 vs. +0.74 g/L/week over weeks 0 - 4; q = 0.028). Adverse events occurred in 47.7%, mostly grade 1 - 2, without between-group differences in serious events or discontinuation. Higher C-reactive protein (per 10 mg/L, OR 0.42; q = 0.012) and poor prior ESA response (OR 0.60; q = 0.013) predicted lower target attainment, whereas higher prealbumin (per 10 mg/L, OR 1.35; q = 0.004), IV iron (OR 1.52; q = 0.021), and ≥ 50% dose titration (OR 1.59; q = 0.019) predicted higher attainment. CONCLUSION: Roxadustat improved and stabilized Hb across anemia severities in MHD, with best control in milder anemia; inflammation, nutrition, prior ESA response, iron use, and dose titration influenced success.