P41 | Efficacy and safety of Roxadustat in patients with anemia of dialysis-dependent chronic kidney disease with or without inflammation: pooled analysis of four phase 3 studies

G. Choukroun¹, A. Harkavyi², V. Santos³, A. Jiletcovici³, L. Del Vecchio⁴ | ¹CHU Amiens Picardie and Jules Verne University, Amiens, France, ²Astellas Pharma Europe, Addlestone, UK, ³Astellas Pharma, Inc., Northbrook, USA, ⁴Sant’Anna Hospital, ASST Lariana, Como, Italy

Premises and Purpose of the Study: Inflammation may contribute to erythropoiesis-stimulating agent (ESA) hyporesponsiveness. This pooled analysis evaluated the efficacy and safety of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, in correcting hemoglobin (Hb) levels in patients with dialysis-dependent (DD) chronic kidney disease (CKD) by baseline inflammation levels.
Materials and Methods: Four phase 3, randomized, open-label, active comparator‒controlled studies (HIMALAYAS [NCT02052310], ROCKIES [NCT02174731], PYRENEES [NCT02278341], SIERRAS [NCT02273726]) were pooled. Mean Hb change from baseline (CFB) to Weeks 28‒52 and mean weekly roxadustat dose (mg/kg body weight) at Week 24 by baseline inflammation levels (as determined by high-sensitivity C-reactive protein [hsCRP] quintiles) were analyzed. Safety data were summarized descriptively.
Results: In total, 4072 patients with DD CKD (roxadustat N=2022; ESA N=2050) were evaluated. Hb CFB to Weeks 28-52 was greater in patients treated with roxadustat compared with ESA, regardless of baseline inflammation. Patients with higher baseline hsCRP levels did not require higher doses of roxadustat compared to patients with lower baseline hsCRP levels. The overall percentages of patients with at least one treatment-emergent adverse event were similar for patients treated with roxadustat or ESA across hsCRP quintiles.
Conclusions: Roxadustat increased Hb levels, without requiring increased doses, independent of baseline inflammation and had a comparable safety profile to ESA.