- |||||||||| Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
Journal, HEOR: Variation in health plan coverage of ESAs for anemia due to chronic kidney disease. (Pubmed Central) - Nov 24, 2021
Margaretos, Panzer, and Chambers are employed by Tufts Medical Center, Institute for Clinical Research and Health Policy Studies, Center for the Evaluation of Value and Risk in Health. Lai was with Tufts Medical Center, Institute for Clinical Research and Health Policy Studies, Center for the Evaluation of Value and Risk in Health at the time of this study.
- |||||||||| Cosela (trilaciclib) / G1 Therap, Epogen (epoetin alfa) / Amgen
Comparative Cost-Efficiency Analysis of Trilaciclib, a Novel CDK4/6 Inhibitor, in the Prophylaxis of Chemotherapy-Induced Myelosuppression (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3501;
As an alternative to single lineage-specific interventions with biological agents for neutropenia ([peg]filgrastim, ), anemia ([darb]epoetin alfa, alfa), and thrombocytopenia (romiplostim), trilaciclib may offer economic value in the prophylaxis and/or management of these adverse events...ASP tends to fluctuate more than WAC and is typically lower hence an ASP-based cost model may likely underrepresent the cost-efficiency of trilaciclib, as may be the case in the neutropenia/anemia scenario. (Data will be updated by conference time with the trilaciclib ASP if available).
- |||||||||| Epogen (epoetin alfa) / Amgen
[VIRTUAL] PURE RED CELL APLASIA DUE TO PROBABLE ANTI-ERYTHROPOETIN ANTIBODY IN HEMODIALYSIS PATIENT: CASE REPORT () - Oct 27, 2021 - Abstract #HEMO2021HEMO_1392;
Introduction Pure Red Series Aplasia (PSV) is a rare, autoimmune clinical syndrome characterized by severe, progressive and hypoproliferative anemia, marked by a reduction or absence of erythroblasts in the bone marrow, with normal presence of other strains. This condition, although rare, may be associated with the use of recombinant human epoetin alfa (EPOHuR) in dialysis patients or with other immunological diseases, such as systemic lupus erythematosus and viral infections (parvovirus B19)...In March 2017, the The patient evolved with persistent drop in hemoglobin values (Hb: March = 10 g/dL, April = 9 g/dL, May = 7.5 g/dL and June: 5 g/dL), being referred to the hematology clinic and investigation of anemia started. Laboratory tests revealed: Hb = 4 g/dL; Ht = 12.7%; L = 4,070/L; Plaq: 150000 thousand/mm3; reticulocytes = 0.5%; BT = 0.5; BI = 0.3; LDH = 166; Ferritin = 1846 g/dL, Fe = 233 µg/dL; B12=218 pg/ml; direct coombs=non-reactive; TSH = 6.36 IU/ml. In addition to these tests, an upper digestive endoscopy was performed, which did not reveal sources of digestive bleeding, and a myelogram, showing severe hypoplasia of the erythroid lineage only; being confirmed by bone marrow biopsy which suggested a pure red-series aplasia (APSV). After the biopsy result, a search for parvovirus B19 was requested, with a negative result, thus suggesting, as the most likely hypothesis, APSV associated with anti-EPO antibody. It was not possible to carry out the investigation of anti-EPO antibody due to the high cost of the test. In August 2018, the therapeutic trial was started, with prednisone 1 mg/kg/day and the patient remained without the use of EPOHuR. There was a progressive improvement in hemoglobin values 30 days after the start of treatment (Hb = 9.1 g/dL), with no need for transfusion support since then. After 6 months of treatment with progressive weaning from corticosteroids, there was a further drop in hemoglobin levels, making it necessary to maintain low doses of prednisone for a long time. Currently, it maintains Hb levels close to normal values (April/2021: Hb = 11 g/dL)...-EPO, blocking the interaction of EPO and its receptors. The diagnosis of this pathology can be made by searching for anti-EPO antibody or by excluding other causes of anemia, with a compatible clinical picture. The use of immunosuppressive drugs is necessary for the treatment of this hematological condition.Conclusion Although APSV is a rare condition, it should always be suspected as a cause of anemia refractory to the use of EPOHuR, in patients with chronic kidney disease, after the most common causes are excluded. of anemia in these patients. Since it is a condition of severe anemia and spontaneous remission is not usually common, the immediate use of immunosuppressants is necessary to improve the clinical condition.
- |||||||||| Epogen (epoetin alfa) / Amgen
[VIRTUAL] Serratia liquefaciens Bacteremia in Two Dialysis Patients () - Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_3704;
Cultures grew E. cloacae; vancomycin and gentamicin were administered...Ten cases of S. liquefaciens blood stream infection and six pyrogenic reactions at a hemodialysis center in 2001 were found to be related to multiple punctures of single-use vials with pooling of preservative-free Epogen® 2...Vigilance must be paid to reduce the risk of infection. The differential diagnosis for bacteremia must be broad and treatment must cover relatively unusual etiologies.
- |||||||||| Epogen (epoetin alfa) / Amgen
[VIRTUAL] Effect of Hemodialysis Rounding Report Availability on Hospitalized ESRD Patient Parameters () - Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_3689;
Patients with available outpatient dialysis reports were restarted on the same outpatient doses of Epogen, phosphate binders, and EDW was adjuted to the same outpatient HD EDW...Table 1. Conclusion Patients who have dialysis rounding reports available to guide their treatment while hospitalized have better dialysis-related parameters than those who don’t.
- |||||||||| Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
[VIRTUAL] Severe ESA Resistance Reversed by Cinacalcet in a Hemodialysis Patient with Sickle Cell Anemia () - Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_3664;
His anemia had been treated with hydroxyurea and high dose subcutaneous Aranesp (400 μg every 2 weeks) with a mean hemoglobin (Hgb) of 6.4 (1.4) mg/dL over several years...Following day 500, supplemental Epogen was given in addition to Aranesp, but Hgb increased only when PTH was most suppressed...These Hgb peaks were reproducible and sustained whenever PTH suppression was achieved. This case demonstrates that some hyperparathyroidism-related ESA resistance may be reversible and supports how important control of bone mineral disease is in specific populations of HD patients that are susceptible to severe anemia.
- |||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
[VIRTUAL] Roxadustat in Elderly Patients with Anemia of CKD () - Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_1232;
Roxadustat was well tolerated, regardless of age (Table). Conclusion Roxadustat was effective and well tolerated, regardless of age, in patients with anemia of CKD.
- |||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
[VIRTUAL] Roxadustat Effectively Treats Anemia in Dialysis-Dependent CKD (DD-CKD) Patients with Ferritin ≥500 ng/mL () - Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_1231;
Conclusion In DD-CKD pts with high ferritin, EPO pts had lower Hb and impaired iron mobilization despite increased IV iron use and EPO dose. Roxadustat drove ferritin reductions and increased serum iron and transferrin, with minimal dose change, and is an alternative to ESA for DD-CKD pts with high ferritin.
- |||||||||| Epogen (epoetin alfa) / Amgen
[VIRTUAL] Hypersensitivity Reaction to Epoetin-Alfa: A Therapeutic Challenge () - Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_1224;
Cross-reactivity has been reported between different ESA structures, which raises a therapeutic challenge in the care of such patients. Clinicians should consider desensitization, which can lead to successful re-introduction of ESA therapy.
- |||||||||| Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
[VIRTUAL] Contemporary Anemia Treatment in Prevalent Patients Undergoing Hemodialysis () - Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_1217;
Mean (median) weekly doses were 10,562 (7727) IU for epoetin alfa, 35.9 (23.0) mcg for darbepoetin alfa, and 33.6 (23.0) mcg for pegylated epoetin beta. Conclusion Between 2015 and 2019, despite substantial flux in the mix of ESAs used, distributions of hemoglobin and ESA doses among patients undergoing HD were stable, with only a small percentage of patients experiencing persistently low hemoglobin.
- |||||||||| Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
Clinical, P3 data, Journal: Roxadustat for the Maintenance Treatment of Anemia in Patients with End-Stage Kidney Disease on Stable Dialysis: A European Phase 3, Randomized, Open-Label, Active-Controlled Study (PYRENEES). (Pubmed Central) - Oct 13, 2021
Roxadustat was non-inferior to ESAs in maintaining hemoglobin levels in this cohort of patients with anemia of CKD on dialysis for at least 4 months who were previously treated with ESAs. Observed TEAEs were consistent with previous studies.
- |||||||||| Epogen (epoetin alfa) / Amgen, Revlimid (lenalidomide) / BMS
Journal, Monotherapy: Lenalidomide-Epoetin Alfa Versus Lenalidomide Monotherapy in Myelodysplastic Syndromes Refractory to Recombinant Erythropoietin. (Pubmed Central) - Sep 29, 2021
P3
Despite the limited knowledge regarding some prescribed medications, most of the hospital pharmacists showed good practices toward dialysis patients. LEN restores sensitivity to recombinant erythropoietin in growth factor-insensitive, lower-risk, non-del(5q) MDS, to yield a significantly higher rate and duration of MER compared with LEN alone (funded by the National Cancer Institute; E2905 ClinicalTrials.gov identifier: NCT02048813).
- |||||||||| Epogen (epoetin alfa) / Amgen
When Blood Is Not An Option: Complex Hepatectomy In A Jehovah's Witness (Exhibit Hall) - Sep 25, 2021 - Abstract #ASA2021ASA_4768;
Iron supplementation and epoetin alfa are used to optimize hemoglobin preoperatively. Multidisciplinary discussion and planning which includes preoperative optimization combined with multimodal blood conservation is crucial to success in this case.
- |||||||||| Epogen (epoetin alfa) / Amgen
Review, Journal: Systematic Review of Erythropoietin (EPO) for Neuroprotection in Human Studies. (Pubmed Central) - Sep 16, 2021
The PubMed search resulted in the following search strategy: ("erythropoietin" [MeSH Terms] OR "erythropoietin" [All Fields] OR "epoetin alfa" [MeSH Terms] OR ("epoetin" [All Fields] AND "alfa" [All Fields]) OR "epoetin alfa" [All Fields]) AND ("neuroprotection" [MeSH Terms] OR "neuroprotection" [All Fields]) AND "humans" [MeSH Terms]...We found no studies to date evaluating the role of EPO in post-operative pain. Future trials could evaluate this application in persistent post-surgical pain and in the peri-operative period.
- |||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
Clinical, Journal: A Randomized Trial of Roxadustat in Anemia of Kidney Failure: SIERRAS Study. (Pubmed Central) - Jul 27, 2021
In end-stage kidney disease, roxadustat was noninferior to epoetin alfa in up to 52 weeks of treatment in this erythropoietin-stimulating agent conversion study. Roxadustat had an acceptable tolerability profile.
- |||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
Retrospective data, Review, Journal: Safe and Effective Treatment for Anemic Patients With Chronic Kidney Disease: An Updated Systematic Review and Meta-Analysis on Roxadustat. (Pubmed Central) - Jul 20, 2021
But the incidence of serious TEAEs in the roxadustat group was significantly higher with NDD-CKD patients (OR: 1.15; 95% CI: 1.02-1.29). This study confirmed that roxadustat therapy could alleviate the anemia of DD-CKD and NDD-CKD patients by raising the hemoglobin level and regulating iron metabolism, but increased serious incidences of treatment-emergent adverse events (TEAEs) in NDD-CKD patients.
- |||||||||| Epogen (epoetin alfa) / Amgen
Clinical, Review, Journal, HEOR: Impatto economico dell'utilizzo di carbossimaltosio ferrico nei pazienti in emodialisi (Pubmed Central) - Jul 10, 2021
In addition, specific sensitivity analyses considered prices currently applied at the regional level, simulating the use of IS vs iron gluconate (FG) and epoetin beta vs epoetin alfa...Le analisi di sensibilità, sempre favorevoli a FCM, hanno confermato la robustezza dell'analisi. FCM può rappresentare un notevole risparmio per il SSN, e sono auspicabili studi real-world condotti in Italia che quantifichino il reale consumo di risorse nei pazienti dialitici.
- |||||||||| Epogen (epoetin alfa) / Amgen
Clinical, Journal: Incentives to promote the US pharmaceutical innovation: empirical research based on the case of Epogen. (Pubmed Central) - Jul 8, 2021
Monopoly pricing was a significant determinant to increase the sales of Epogen through pricing strategies.Conclusion - We pointed out that Amgen has developed the successful innovation of Epogen taking advantages of the incentives. Effective and flexible incentives and policies are essential to support the entire life cycle of new drugs, ultimately forming a sustainable driver for the long-run pharmaceutical innovation.
- |||||||||| Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
Review, Journal: Anemia Management in Peritoneal Dialysis: Perspectives From the Asia Pacific Region. (Pubmed Central) - Jun 22, 2021
The route and dosage of iron administration in PD patients requires more research studies. With the introduction of oral hypoxia-inducible factor prolyl hydroxylase inhibitors into clinical use, the landscape of treatment of anemia in the PD population in the Asia Pacific region may change in the coming years.
- |||||||||| Eprex (epoetin alfa) / J&J, Epogen (epoetin alfa) / Amgen, Venofer (iron sucrose complex) / Daiichi Sankyo, CSL Behring
Enrollment change, Trial completion date, Trial termination, Adverse events: HOPE-Hb: Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia (clinicaltrials.gov) - Jun 18, 2021
P2, N=4, Terminated,
With the introduction of oral hypoxia-inducible factor prolyl hydroxylase inhibitors into clinical use, the landscape of treatment of anemia in the PD population in the Asia Pacific region may change in the coming years. N=74 --> 4 | Trial completion date: Dec 2021 --> May 2021 | Recruiting --> Terminated; The primary reasoning is that we were unable to demonstrate feasibility, prior to and because of the impact of COVID on our research programs.
- |||||||||| [VIRTUAL] A PHASE 3 STUDY OF THE EFFICACY AND SAFETY OF LUSPATERCEPT VERSUS EPOETIN ALFA FOR THE TREATMENT OF ANEMIA DUE TO LOWER-RISK MDS IN ESA-NAIVE PATIENTS REQUIRING RBC TRANSFUSIONS (THE COMMANDS TRIAL) () - May 13, 2021 - Abstract #EHA2021EHA_1636;
P3
Epoetin alfa and darbepoetin alfa have shown efficacy among pts with LR-MDS, but the pt population in whom a clinically significant effect is seen may be limited...Exclusion criteria include prior use of ESAs (≤2 doses of prior epoetin alfa permitted if ≥8 weeks from randomization date and sEPO confirmed as ≤ 500 U/L), granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor, unless administered for treatment of febrile neutropenia; disease-modifying agents (e.g. lenalidomide), or hypomethylating agents; and presence of del(5q) cytogenetic abnormality...Key secondary endpoints include duration of RBC-TI, change in Hb levels, achievement of HI-E (per International Working Group [IWG] 2006), and safety. Conclusion The COMMANDS trial is registered at EudraCT (number 2017-003190-34) and ClinicalTrials.gov (NCT03682536).
- |||||||||| Epogen (epoetin alfa) / Amgen
Journal: UPLC-MS assessment on the structural similarity of recombinant human erythropoietin (rhEPO) analogues from manufacturers in China for attribute monitoring. (Pubmed Central) - May 1, 2021
Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets...Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans.
- |||||||||| Epogen (epoetin alfa) / Amgen, NN1213 / Novo Nordisk
Trial completion: OETNA: Optimized Erythropoietin (EPO) Treatment (clinicaltrials.gov) - Apr 29, 2021
P2, N=62, Completed,
The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. Active, not recruiting --> Completed
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