INDICATIONS

REBLOZYL (luspatercept-aamt) is indicated for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.

REBLOZYL (luspatercept-aamt) is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

REBLOZYL (luspatercept-aamt) is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Request a Rep

THE DETRIMENT OF ANEMIA

Effect of transfusion burden on OS in patients with de novo MDS3,4*

Graph outlining overall survival percentage and time of patients OS in patients with de novo MDS
Graph outlining overall survival percentage and time of patients OS in patients with de novo MDS

Retrospective analysis evaluating 426 patients diagnosed with MDS between 1992 and 2004

Study design: Analysis of a study by the Düsseldorf MDS Registry in 426 patients diagnosed with MDS according to WHO criteria between 1992 and 2004. Survival of MDS patients according to the intensity of their RBC transfusion requirement was calculated as the number of packed red cell (PRC) units per month (U/4 Wk). The between-group comparison was performed by applying a Cox proportional hazard regression model with time-dependent covariates.

Impact of Hgb level on OS5*

Graph outlining the median survival against levels of Hgb (g/dL) Graph outlining the median survival against levels of Hgb (g/dL)

Analysis based on combined international databases of 7012 patients with primary untreated MDS

Study design: Multiple MDS databases of primary untreated MDS patients from 11 countries were coalesced to assemble a much larger combined database (n=7012) for analysis. Multiple statistically weighted clinical features were used to generate a prognostic categorization model. Parameters evaluated were cytogenetic risk category, marrow aspirate blast percent, depth of cytopenias, degree of marrow fibrosis (0-1+ vs 2-3+), Eastern Cooperative Oncology Group performance status, serum LDH (normal values defined by each hospital), ferritin and 2-microglobulin levels, RBC transfusion dependence, and patient age at diagnosis. Modeling of prognostic risk was based on multivariate analysis of survival time and time to AML transformation.

AML=acute myeloid leukemia; Hgb=hemoglobin; MDS=myelodysplastic syndromes; OS=overall survival; PRBC=packed red blood cell; RBC=red blood cell.

*In patients with MDS.

THE DETRIMENT OF ANEMIA

Effect of transfusion burden on OS in patients with de novo MDS3,4*

Graph outlining overall survival percentage and time of patients OS in patients with de novo MDS
Graph outlining overall survival percentage and time of patients OS in patients with de novo MDS

Retrospective analysis evaluating 426 patients diagnosed with MDS between 1992 and 2004

Study design: Analysis of a study by the Düsseldorf MDS Registry in 426 patients diagnosed with MDS according to WHO criteria between 1992 and 2004. Survival of MDS patients according to the intensity of their RBC transfusion requirement was calculated as the number of packed red cell (PRC) units per month (U/4 Wk). The between-group comparison was performed by applying a Cox proportional hazard regression model with time-dependent covariates.

Impact of Hgb level on OS5*

Graph outlining the median survival against levels of Hgb (g/dL) Graph outlining the median survival against levels of Hgb (g/dL)

Analysis based on combined international databases of 7012 patients with primary untreated MDS

Study design: Multiple MDS databases of primary untreated MDS patients from 11 countries were coalesced to assemble a much larger combined database (n=7012) for analysis. Multiple statistically weighted clinical features were used to generate a prognostic categorization model. Parameters evaluated were cytogenetic risk category, marrow aspirate blast percent, depth of cytopenias, degree of marrow fibrosis (0-1+ vs 2-3+), Eastern Cooperative Oncology Group performance status, serum LDH (normal values defined by each hospital), ferritin and 2-microglobulin levels, RBC transfusion dependence, and patient age at diagnosis. Modeling of prognostic risk was based on multivariate analysis of survival time and time to AML transformation.

AML=acute myeloid leukemia; Hgb=hemoglobin; MDS=myelodysplastic syndromes; OS=overall survival; PRBC=packed red blood cell; RBC=red blood cell.

*In patients with MDS.

References: 1. REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2022. 2. Kaka S, Jahangirnia A, Beauregard N, et al. Red blood cell transfusion in myelodysplastic syndromes: a systematic review. Transfus Med. 2022;32(1):3-23. 3. Malcovati L, Della Porta MG, Pascutto C, et al. Prognostic factors and life expectancy in myelodysplastic syndromes classified according to WHO criteria: a basis for clinical decision making. J Clin Oncol. 2005;23(30):7594-7603. 4. Malcovati L, Della Porta MG, Cazzola M. Predicting survival and leukemic evolution in patients with myelodysplastic syndrome. Haematologica. 2006;91(12)1588-1590. 5. Greenberg PL, Tuechler H, Schanz J, et al. Revised International Prognostic Scoring System for myelodysplastic syndromes. Blood. 2012;120(12):2454-2465.

2007-US-2300019     04/2023