Assessment of efficacy and safety of once monthly dosing methoxy polyethylene glycol-epoetin beta in patients with anemia on hemodialysis

Background and objectives. Monthly injection of a continuous erythropoietin receptor activator (C.E.R.A.) represents a more convenient and manageable schedule of administration than the more frequent dosing of currently available epoetin treatments. The study was undertaken to assess the maintenance of hemoglobin concentrations with once a month intravenous C.E.R.A. therapy in dialysis patients with chronic renal anemia who was previously treated with standard epoetin alfa or beta. Design and methods: ALIСE was a prospective, open-label, multicenter study performed at 19 nephrology centers in Russia. After 4 week Stability Verification Period, hemodialysis patients receiving epoetins were converted to monthly intravenous C.E.R.A., with a 16 weeks Titration Phase followed by a 8-weeks Evaluation Phase and 28 weeks - Long Safety Evaluation Period. Results: of 241 patients screened, 200 started C.E.R.A. therapy; 162 were eligible for inclusion in the intent-to-treat population, 145 patients were selected for Protocol Population Aanalysis. The target hemoglobin level of 10.5-12.5 g/dL with variation of ±1 g/dL during the evaluation phase, was achieved in 79 (54.5%) patients [95% CI 46.0 - 62.8%; PP analysis], respectively. During the screening and evaluation phases, mean hemoglobin were 11.7 ± 0.52 g/dL and 11.4 ± 1.0 g/dL, respectively. In PP population the targeted hemoglobin level was achieved in 127 patients (87.6%). C.E.R.A. was well-tolerated with a safety profile similar to that reported in phase III studies. Conclusions: this open-label, multicenter study confirmed that conversion of hemodialysis patients from standard epoetin alfa or beta to monthly C.E.R.A. administration is practical, convenient, safe and offers good control of hemoglobin levels.

ренальная анемия, эритропоэз-стимулирующий препарат (ЭСП) с длительной активацией рецепторов эритропоэтина (C.E.R.A.), эндогенный эритропоэтин (ЭПО), гемодиализ, контроль уровня гемоглобина, назначение 1 раз в месяц, метоксиполиэтиленгликоль-эпоэтин бета (МЭБ), chronic renal anemia, continuous erythropoietin receptor activator (C.E.R.A.), hemodialysis, Hb control, monthly administration , methoxy polyethylene glycol-epoetin beta

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