Recombinant erythropoietin biosimilar(Elea Spa)

Background: Patient blood management (PBM) is a multidisciplinary and patient-centered treatment approach, comprising the detection and treatment of anemia, the minimization of blood loss, and the rational use of allogeneic transfusions. Pregnancy, delivery, and the puerperium are associated with increased rates of iron deficiency and anemia, which correlates with worse maternal and fetal outcomes and places pregnant women at increased risk of obstetric hemorrhage. Summary: Early screening for iron deficiency before the onset of anemia, as well as the use of oral and intravenous iron to treat iron deficiency anemia, has been shown to be beneficial. Anemia in pregnancy and the puerperium should be treated according to a staged regimen, administering either iron alone or in combination with an off-label use of human recombinant erythropoietin in selected patients. This regimen should be tailored to the needs of each individual patient. Postpartum hemorrhage (PPH) accounts for up to one-third of maternal deaths in both developing and developed countries. Bleeding complications should be anticipated and blood loss reduced by interdisciplinary preventive measures and individually tailored care. It is recommended that facilities have a PPH algorithm, primarily focusing on prevention through use of uterotonics, but also incorporating early diagnosis of the cause of bleeding, optimization of hemostatic conditions, timely administration of tranexamic acid, and integration of point-of-care tests to support the guided substitution of coagulation factors, alongside standard laboratory tests. Additionally, cell salvage has proven beneficial and should be considered for various indications in obstetrics including hematologic disturbances, as well as various forms of placental disorders. Key Message: This article reviews PBM in pregnancy, delivery, and the puerperium. The concept comprises early screening and treatment of anemia and iron deficiency, a transfusion and coagulation algorithm during delivery, as well as cell salvage.

Introduction: Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for treating anemia of chronic kidney disease (CKD). This post hoc analysis of a Japanese, open-label, partially randomized, phase 3 study in nondialysis-dependent (NDD) CKD patients treated with traditional erythropoiesis-stimulating agents (ESAs) evaluated dosing trends of roxadustat and darbepoetin alfa (DA) required to maintain target hemoglobin concentrations in patients with risk factors associated with ESA hyporesponsiveness. Methods: Patients enrolled in the 1517-CL-0310 study (NCT02988973) that demonstrated noninferiority of roxadustat to DA for change in average hemoglobin levels of week 18–24 from baseline who had used human recombinant erythropoietin or DA before conversion and who were randomized to either roxadustat or DA were included. The endpoints were the average allocated dose of roxadustat and DA per administration in the last 6 weeks (AAD/6W), assessed by subgroups known to be associated with ESA hyporesponsiveness. The analysis of variance was performed by the treatment group to test the influence of subgroup factors on the AAD/6W of study drug. The ratios between the mean AAD/6W in each subgroup category and the within-arm mean AAD/6W were calculated. Results: Two hundred and sixty-two patients were randomized to either the roxadustat or DA comparative group and received treatment (roxadustat, n = 131; DA, n = 131). Higher mean (standard deviation) doses of both roxadustat (63.15 [24.84] mg) and DA (47.33 [29.79] μg) were required in the highest ESA resistance index (≥6.8) quartile (p = 0.003 and p < 0.001, respectively). Patients with adequate iron repletion had the lowest doses for both roxadustat (45.54 [18.01] mg) and DA (28.13 [20.98] μg). High-sensitivity C-reactive protein ≥28.57 nmol/L and the estimated glomerular filtration rate <15 mL/min/1.73 m² were associated with requiring higher DA but not roxadustat doses. Discussion/Conclusion: The roxadustat dose required to maintain target hemoglobin in NDD patients in Japan with anemia of CKD relative to DA dose may not be impacted by low-grade inflammation. Roxadustat may be beneficial for ESA-hyporesponsive NDD CKD patients.