Comparative risk/benefit profile of biosimilar and originator erythropoiesis-stimulating agents (ESAs): data from an Italian observational study in nephrology
ConclusionsBiosimilar ESAs have similar risk/benefit profile compared to originators. Our data are in agreement with relevant scientific literature and, on the other hand, they are in contrast with common thought that considers biosimilar less efficacious and less safe than originators. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - February 10, 2018 Category: Drugs & Pharmacology Source Type: research
Efficacy and Long-Term Safety of C.E.R.A. Maintenance in Pediatric Hemodialysis Patients with Anemia of CKD.
CONCLUSIONS: Using a defined conversion factor, 4-weekly C.E.R.A. was efficacious in maintaining hemoglobin levels in pediatric patients with stable anemia of CKD undergoing hemodialysis, switching from maintenance treatment with epoetin alfa/beta or darbepoetin. Safety was consistent with the known C.E.R.A. safety profile in adults.
PMID: 29097481 [PubMed - as supplied by publisher] (Source: Clinical Journal of the American Society of Nephrology : CJASN)
Source: Clinical Journal of the American Society of Nephrology : CJASN - November 2, 2017 Category: Urology & Nephrology Authors: Fischbach M, Wühl E, Reigner SCM, Morgan Z, Schaefer F Tags: Clin J Am Soc Nephrol Source Type: research
A Comparison of the Safety and Efficacy of HX575 (Epoetin Alfa Proposed Biosimilar) with Epoetin Alfa in Patients with End-Stage Renal Disease
Conclusions: SC HX575 in dialysis patients with renal anemia was therapeutically equivalent to the reference medicine in terms of maintaining stable Hb levels and safety.Am J Nephrol 2017;46:364 –370 (Source: American Journal of Nephrology)
Source: American Journal of Nephrology - October 30, 2017 Category: Neurology Source Type: research
A Comparison of the Safety and Efficacy of HX575 (Epoetin Alfa Proposed Biosimilar) with Epoetin Alfa in Patients with End-Stage Renal Disease.
CONCLUSIONS: SC HX575 in dialysis patients with renal anemia was therapeutically equivalent to the reference medicine in terms of maintaining stable Hb levels and safety.
PMID: 29084409 [PubMed - as supplied by publisher] (Source: American Journal of Nephrology)
Source: American Journal of Nephrology - October 30, 2017 Category: Urology & Nephrology Authors: Weir MR, Pergola PE, Agarwal RL, Fink JC, Kopyt NP, Singh AK, Kumar J, Schmitt S, Schaffar G, Rudy A, McKay JP, Kanceva R Tags: Am J Nephrol Source Type: research
Successful treatment of chronic hepatitis C virus infection in a patient receiving daily peritoneal dialysis.
CONCLUSION: A patient with end-stage renal disease requiring PD was treated successfully for HCV genotype 1a infection with PrOD fixed-dose combination therapy plus ribavirin therapy. The patient achieved an SVR12 despite withdrawal of ribavirin at treatment week 10, with minimal adverse effects reported.
PMID: 28947525 [PubMed - in process] (Source: American Journal of Health-System Pharmacy : AJHP)
Source: American Journal of Health-System Pharmacy : AJHP - September 29, 2017 Category: Drugs & Pharmacology Authors: Stark JE, Cole J Tags: Am J Health Syst Pharm Source Type: research
Evaluation of the combined effects of pegylation and glycosylation on the stability of erythropoietin using a stability-indicating SE-HPLC
Publication date: Available online 27 September 2017 Source:Biologicals Author(s): Heba S. Abed, Medhat A. Al-Ghobashy, Faten A. Fathalla, Maissa Y. Salem Recombinant human erythropoietin (rhEPO) is a commonly used biopharmaceutical for the treatment of anemia-associated disorders. Epogen; glycosylated erythropoietin (G-EPO) has short half-life and poor stability. Pegylated Epogen (Peg-G-EPO) was introduced to the market to overcome these limitations. The combined effects of pegylation and glycosylation on the stability of Peg-G-EPO was studied. Determination of Peg-G-EPO in the presence of its degradation products w...
Source: Biologicals - September 29, 2017 Category: Biology Source Type: research
Evaluation of the combined effects of pegylation and glycosylation on the stability of erythropoietin using a stability-indicating SE-HPLC.
Abstract
Recombinant human erythropoietin (rhEPO) is a commonly used biopharmaceutical for the treatment of anemia-associated disorders. Epogen; glycosylated erythropoietin (G-EPO) has short half-life and poor stability. Pegylated Epogen (Peg-G-EPO) was introduced to the market to overcome these limitations. The combined effects of pegylation and glycosylation on the stability of Peg-G-EPO was studied. Determination of Peg-G-EPO in the presence of its degradation products was achieved using SE-HPLC. The assay was validated according to ICH guidelines over concentration range of 50.00-320.00 μg/mL (r 0.99...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 25, 2017 Category: Biotechnology Authors: Abed HS, Al-Ghobashy MA, Fathalla FA, Salem MY Tags: Biologicals Source Type: research
Continuous erythropoiesis receptor activator (CERA) for the anaemia of chronic kidney disease.
CONCLUSIONS: There is low certainty evidence that CERA has little or no effects on patient-centred outcomes compared with placebo, epoetin alfa or beta or darbepoetin alfa for adults with CKD. The effects of CERA among children who have CKD have not studied in RCTs.
PMID: 28782299 [PubMed - as supplied by publisher] (Source: Cochrane Database of Systematic Reviews)
Source: Cochrane Database of Systematic Reviews - August 7, 2017 Category: General Medicine Authors: Saglimbene VM, Palmer SC, Ruospo M, Natale P, Craig JC, Strippoli GF Tags: Cochrane Database Syst Rev Source Type: research
Evaluation of the safety and immunogenicity of subcutaneous HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in predialysis and dialysis patients
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CONCLUSIONS: SC HX575 was effective for correcting and maintaining correction of anemia, and the mean weekly dose remained stable over time.
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PMID: 28766493 [PubMed - as supplied by publisher] (Source: Clinical Nephrology)
Source: Clinical Nephrology - August 2, 2017 Category: Urology & Nephrology Authors: Casadevall N, Dobronravov V, Eckardt KU, Ertürk S, Martynyuk L, Schmitt S, Schaffar G, Rudy A, Krendyukov A, Ode M Tags: Clin Nephrol Source Type: research
Smad1/5 is required for erythropoietin-mediated suppression of hepcidin in mice
Anemia suppresses liver hepcidin expression to supply adequate iron for erythropoiesis. Erythroferrone mediates hepcidin suppression by anemia, but its mechanism of action remains uncertain. The bone morphogenetic protein (BMP)–SMAD signaling pathway has a central role in hepcidin transcriptional regulation. Here, we explored the contribution of individual receptor-activated SMADs in hepcidin regulation and their involvement in erythroferrone suppression of hepcidin. In Hep3B cells, SMAD5 or SMAD1 but not SMAD8, knockdown inhibited hepcidin (HAMP) messenger RNA (mRNA) expression. Hepatocyte-specific double-knockout S...
Source: Blood - July 6, 2017 Category: Hematology Authors: Wang, C.-Y., Core, A. B., Canali, S., Zumbrennen-Bullough, K. B., Ozer, S., Umans, L., Zwijsen, A., Babitt, J. L. Tags: Red Cells, Iron, and Erythropoiesis Source Type: research
Biosimilar epoetin alfa increases haemoglobin levels and brings cognitive and socio-relational benefits to elderly transfusion-dependent multiple myeloma patients: results from a pilot study
AbstractAnaemia is a complication reported in up to 70% of the multiple myeloma patients (MM), with remarkable clinical, cognitive and socio-relational consequences. Anaemia relates to the course of MM, normalizing in patients during remission and reappearing in relapsing/non-responding patients. In a pilot study with 31 patients with MM and transfusion-dependent anaemia, we evaluated the effects of Binocrit (biosimilar epoetin alfa) on transfusions, haemoglobin levels, mental status (mini-mental state evaluation) and the patients ’ social-relational functioning and quality of life (QoL). Within a 12-week interval, patie...
Source: Annals of Hematology - March 30, 2017 Category: Hematology Source Type: research
History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology.
Abstract
BACKGROUND: Exogenous replacement of erythropoietin (EPO) by recombinant human EPO has been considered a standard of care for the treatment of anemia in patients with chronic kidney disease for more than 20 years. Genetically engineered biologic proteins derived from human, animal, or microorganism sources are a major area of growth in modern medical care, accounting for one-third of new drug approvals in the past decade. Despite benefit to patients, the use of biologics comes at a significant cost, representing one of the fastest growing segments of strained healthcare budgets around the world.
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Source: American Journal of Nephrology - January 31, 2017 Category: Urology & Nephrology Authors: Kalantar-Zadeh K Tags: Am J Nephrol Source Type: research
History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology
Background: Exogenous replacement of erythropoietin (EPO) by recombinant human EPO has been considered a standard of care for the treatment of anemia in patients with chronic kidney disease for more than 20 years. Genetically engineered biologic proteins derived from human, animal, or microorganism sources are a major area of growth in modern medical care, accounting for one-third of new drug approvals in the past decade. Despite benefit to patients, the use of biologics comes at a significant cost, representing one of the fastest growing segments of strained healthcare budgets around the world.Summary: Biosimilars, or bio...
Source: American Journal of Nephrology - January 31, 2017 Category: Neurology Source Type: research
Erythropoiesis-stimulating Agents in Critically Ill Trauma Patients: A Systematic Review and Meta-analysis
Conclusions: The administration of ESAs to critically ill trauma patients is associated with a significant improvement in mortality without an increase in the rate of lower limb proximal deep venous thrombosis. Given the worldwide public health significance of these findings research to validate or refute them is required. (Source: Annals of Surgery)
Source: Annals of Surgery - December 30, 2016 Category: Surgery Tags: Meta-Analysis Source Type: research
Epoetin Alfa and Outcomes in Dialysis amid Regulatory and Payment Reform
Erythropoiesis-stimulating agents (ESAs) are commonly used to treat anemia in patients with CKD, including those receiving dialysis, although clinical trials have identified risks associated with ESA use. We evaluated the effects of changes in dialysis payment policies and product labeling instituted in 2011 on mortality and major cardiovascular events across the United States dialysis population in an open cohort study of patients on dialysis from January 1, 2005, through December 31, 2012, with Medicare as primary payer. We compared observed rates of death and major cardiovascular events in 2011 and 2012 with expected ra...
Source: Journal of the American Society of Nephrology : JASN - September 29, 2016 Category: Urology & Nephrology Authors: Chertow, G. M., Liu, J., Monda, K. L., Gilbertson, D. T., Brookhart, M. A., Beaubrun, A. C., Winkelmayer, W. C., Pollock, A., Herzog, C. A., Ashfaq, A., Sturmer, T., Rothman, K. J., Bradbury, B. D., Collins, A. J. Tags: Clinical Epidemiology Source Type: research
