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Intravenous Epoetin Alfa-epbx versus Epoetin Alfa for Treatment of Anemia in End-Stage Kidney Disease.

ABSTRACT: BACKGROUND AND OBJECTIVES:This study was conducted to compare the safety and efficacy of intravenous epoetin alfa-epbx, an epoetin alfa biosimilar, to epoetin alfa in patients on hemodialysis with ESKD and anemia. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:In this 24-week, multicenter, double-blind comparative efficacy and safety study, 612 patients on hemodialysis with ESKD and anemia who had stable hemoglobin and were receiving stable doses of intravenous epoetin alfa were randomized (1:1) to intravenous epoetin alfa or epoetin alfa-epbx. Dosing was adjusted according to the epoetin alfa prescribing information. The coprimary efficacy end points were the least squares mean difference between the two treatments in mean weekly hemoglobin level and mean weekly epoetin dose per kilogram of body weight during the last 4 weeks of treatment. RESULTS:The least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly hemoglobin was -0.12 g/dl and the 95% confidence interval (-0.25 to 0.01) was contained within the prespecified equivalence margin (-0.5 to 0.5 g/dl). The least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly epoetin dose per kilogram of body weight was 0.37 U/kg per week, and the 95% confidence interval (-10.40 to 11.13) was contained within the prespecified equivalence margin (-45 to 45 U/kg per week). Incidences of adverse events (77.1% versus 75.3%), serious adverse events (24.9% versus 27.0%), and deaths (n=5 versus 6) were similar between the epoetin alfa-epbx and epoetin alfa groups, respectively. Five patients tested positive for anti-recombinant human erythropoietin antibodies at baseline, and two additional patients (n=1 per group) developed anti-recombinant human erythropoietin antibodies while on study treatment. All patients tested negative for neutralizing antibodies, and no patient in either group experienced an event of pure red cell aplasia. CONCLUSIONS:This 24-week, comparative, clinical trial in patients on hemodialysis with ESKD and anemia demonstrated there is no clinically meaningful difference in efficacy or safety between epoetin alfa-epbx and epoetin alfa.

SUBMITTER: Fishbane S

PROVIDER: S-EPMC6086700 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Intravenous Epoetin Alfa-epbx versus Epoetin Alfa for Treatment of Anemia in End-Stage Kidney Disease.

Fishbane Steven S Singh Bhupinder B Kumbhat Seema S Wisemandle Wayne A WA Martin Nancy E NE

Clinical journal of the American Society of Nephrology : CJASN 20180619 8

<h4>Background and objectives</h4>This study was conducted to compare the safety and efficacy of intravenous epoetin alfa-epbx, an epoetin alfa biosimilar, to epoetin alfa in patients on hemodialysis with ESKD and anemia.<h4>Design, setting, participants, & measurements</h4>In this 24-week, multicenter, double-blind comparative efficacy and safety study, 612 patients on hemodialysis with ESKD and anemia who had stable hemoglobin and were receiving stable doses of intravenous epoetin alfa were ra ...[more]

PMID: 29921734

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Project description:BackgroundErythropoietin is a glycoprotein that mainly regulates erythropoiesis. In patients with chronic renal failure with anemia, darbepoetin alfa can stimulate erythropoiesis, correct anemia, and maintain hemoglobin levels. This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections (Recombinant Human Erythropoietin injection, rHuEPO) when maintaining hemoglobin (Hb) levels within the target range (10.0-12.0 g/dL) for the treatment of renal anemia.MethodsNinety-five patients were enrolled in this study from April 15, 2013 to April 10, 2014 at 25 sites. In this study, patients (n = 95) aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group (n = 56) and a twice or three times per week intravenous epoetin alfa group (n = 39) for 28 weeks, who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease (CKD) and were undergoing hemodialysis or hemofiltration with ESA-naive (erythropoiesis stimulating agent-naive). The primary efficacy profile was the mean Hb level (the non-inferiority margin was -1.0 g/dL, week 21-28); the secondary efficacy profiles were the Hb increase rate (week 0-4), the target Hb achievement cumulative rate and time, the change trends of the Hb levels, and the target Hb maintenance ratio. Adverse events (AEs) were observed and compared, and the efficacy and safety were analyzed between the two treatment groups. Additionally, the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period. SAS® software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators.ResultsThe mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group, respectively; the difference of the lower limits of the 95% confidence intervals (CI) between the two groups was 0.1 g/dL (>-1.0 g/dL), and non-inferiority was proven; the Hb levels started to increase in the first four weeks at a similar increase rate; no obvious differences were observed between the groups in the target Hb achievement cumulative rates, and the Hb levels as well as the target Hb level maintenance rate changed over time. The incidence of AEs was 62.5% in the darbepoetin alfa group and 76.9% in the epoetin alfa group. All the adverse events observed in the study were those commonly associated with hemodialysis.ConclusionDarbepoetin alfa intravenously once per week can effectively increase Hb levels and maintain the target Hb levels well, which makes it not inferior to epoetin alfa intravenously twice or three times per week. Darbepoetin alfa shows an efficacy and safety comparable to epoetin alfa for the treatment of renal anemia.

Project description:BACKGROUND:Clinical practice guidelines regarding the use of high-flux haemodialysis membranes vary widely. OBJECTIVES:We aimed to analyse the current evidence reported for the benefits and harms of high-flux and low-flux haemodialysis. SEARCH METHODS:We searched Cochrane Renal Group's specialised register (July 2012), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1948 to March 2011), and EMBASE (1947 to March 2011) without language restriction. SELECTION CRITERIA:We included randomised controlled trials (RCTs) that compared high-flux haemodialysis with low-flux haemodialysis in people with end-stage kidney disease (ESKD) who required long-term haemodialysis. DATA COLLECTION AND ANALYSIS:Data were extracted independently by two authors for study characteristics (participants and interventions), risks of bias, and outcomes (all-cause mortality and cause-specific mortality, hospitalisation, health-related quality of life, carpal tunnel syndrome, dialysis-related arthropathy, kidney function, and symptoms) among people on haemodialysis. Treatment effects were expressed as a risk ratio (RR) or mean difference (MD), with 95% confidence intervals (CI) using the random-effects model. MAIN RESULTS:We included 33 studies that involved 3820 participants with ESKD. High-flux membranes reduced cardiovascular mortality (5 studies, 2612 participants: RR 0.83, 95% CI 0.70 to 0.99) but not all-cause mortality (10 studies, 2915 participants: RR 0.95, 95% CI 0.87 to 1.04) or infection-related mortality (3 studies, 2547 participants: RR 0.91, 95% CI 0.71 to 1.14). In absolute terms, high-flux membranes may prevent three cardiovascular deaths in 100 people treated with haemodialysis for two years. While high-flux membranes reduced predialysis beta-2 microglobulin levels (MD -12.17 mg/L, 95% CI -15.83 to -8.51 mg/L), insufficient data were available to reliably estimate the effects of membrane flux on hospitalisation, carpal tunnel syndrome, or amyloid-related arthropathy. Evidence for effects of high-flux membranes was limited by selective reporting in a few studies. Insufficient numbers of studies limited our ability to conduct subgroup analyses for membrane type, biocompatibility, or reuse. In general, the risk of bias was either high or unclear in the majority of studies. AUTHORS' CONCLUSIONS:High-flux haemodialysis may reduce cardiovascular mortality in people requiring haemodialysis by about 15%. A large well-designed RCT is now required to confirm this finding.

Dataset Information

Intravenous Epoetin Alfa-epbx versus Epoetin Alfa for Treatment of Anemia in End-Stage Kidney Disease.

Publications

Intravenous Epoetin Alfa-epbx versus Epoetin Alfa for Treatment of Anemia in End-Stage Kidney Disease.

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