Poster: SIERRAS: A Phase 3, Open-Label, Randomized, Active-Controlled Study of the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in Subjects with ESRD on Stable Dialysis
Authors: Chaim Charytan, MD, Nephrology Associates, PC, New Rochelle, New York, et al
Roxadustat (ROXA) is an oral hypoxia–inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and regulates iron metabolism. And the drug — a novel first-in-class treatment for certain people with anemia from chronic kidney disease (CKD) — is being closely watched as its Phase III program pooled analyses continue to prompt headline-worthy news. In short, ROXA shows positive efficacy and no increased cardiovascular risk in patients with anemia from chronic kidney disease.
Specific to the SIERRAS trial, showcased in a larger-than-life poster presentation on Saturday morning, ROXA was non-inferior and subsequently demonstrated superiority over epoetin alfa in dialysis-dedicated patients ({modal url="http://ukidney.com/images/roxa-poster.jpg" title=" A Phase 3, Open-Label, Randomized, Active-Controlled Study of the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in Subjects with ESRD on Stable Dialysis"}click here for poster{/modal}).
The crowd around the SIERRAS poster was dense — and if able to get close enough, the CONCLUSION explained some of the many reasons why everyone’s watching ROXA. Here’s an abbreviated review of SIERRAS’ conclusions.
- ROXA treatment results in a larger hemoglobin increase than epoetin alfa in the subgroup of patients with inflammation and those hyporesponsive to ESA (with high baseline ESA dose).
- ROXA significantly reduced mean LDL cholesterol levels.
- ROXA subjects required less IV iron than epoetin alfa-treated subjects to maintain higher hemoglobin levels, while TSAT levels remain comparable between the two arms throughout.
- ROXA lowers the risk of red blood cell transfusions by 33 percent in comparison to epoetin alfa.
- ROXA was equally efficacious in inflamed and non-inflamed subjects. In contrast, higher epoetin doses were required in inflamed patients than the non-inflamed.
- ROXA effect is durable over time as the average dose requirement remains fairly stable. In contrast, dose requirement increased over time in the epoetin alfa treated patients.
- Overall, TEAEs and TESAEs were balanced between the ROXA and epoetin alfa groups and were generally consistent with those typically expected in study patient population of ESRD on chronic dialysis therapy.
- No safety signal was identified in this study and ROZA was found to be safe for long-term use to maintain hemoglobin in dialysis dependent patients.