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This website is intended for US Healthcare Professionals.
Request a RepINDICATIONS
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® (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 is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.
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Luspatercept-aamt (REBLOZYL®) is recommended by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a first-line treatment option for symptomatic anemia in lower-risk MDS1*
More REBLOZYL patients had a hemoglobin increase of ≥1.5 g/dL in the COMMANDS study2
Secondary endpoint: Patients who achieved mean Hgb increase ≥1.5 g/dL in Weeks 1-242
Median baseline Hgb was 7.8 g/dL in COMMANDS study.2
REBLOZYL improved patients' hemoglobin levels2,3
Secondary endpoint: Mean Hgb change from baseline over 24 weeks (Weeks 1-24)2,3
Median baseline Hgb was 7.8 g/dL in COMMANDS study.2
Analysis limitations for mean Hgb change from baseline over 24 weeks4:
- These endpoints were not included in the statistical testing hierarchy, and no methods were employed to control the Type I error rate.
- These analyses should not be interpreted to determine treatment differences between arms because of lack of statistical hypothesis, testing, and the increased probability of a false-positive finding
Data cutoff date: August 2022.
Nearly all patients required dose adjustments in the COMMANDS clinical trial to reach optimal response5
The National Comprehensive Cancer Network® (NCCN®) recommends treating to a hemoglobin range of 10 to 12 g/dL; not to exceed 12 g/dL6*
A post hoc analysis of COMMANDS using patient-reported outcomes (PROs) across both study arms1
Hemoglobin and its relationship to quality of life1
Quality of Life Core 30 Questionnaire (QLQ-C30)1
The change from baseline in hemoglobin level (1.5 g/dL) threshold and the absolute Hgb value (10 g/dL) threshold were based on recommended response criteria and target Hgb value.
Analysis limitations1,7:
- HRQoL was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire–a validated tool used worldwide to assess QoL in patients with cancer. The statistical significance of QoL is not known. HRQoL was a post hoc analysis of the COMMANDS study and not a prespecified endpoint
For patients with IPSS-R very low-, low-, or intermediate-risk MDS non-del(5q) ± other cytogenetic abnormalities and RS <15% (or RS <5% with an SF3B1 mutation) with sEPO ≤500 mU/mL.6
Coefficients can be interpreted as the change from baseline in PRO score per 1 g/dL increase in Hgb, or the difference in PRO score from baseline while a patient was experiencing a concurrent increase of ≥1.5 g/dL vs <1.5 g/dL from baseline or had a concurrent Hgb value of ≥10 g/dL vs <10 g/dL, depending on the model used.1
PROs and Hgb levels collected in the Phase 3 COMMANDS randomized controlled trial were used to inform the analysis. Two PRO measures were used: the EORTC QLQ-C30 and the FACT-An, which were evaluated at prespecified timepoints. Hgb levels were assessed every 3 weeks or when deemed necessary by investigators. Seven anemia-related domain scores, including EORTC QLQ-C30 global health status/quality of life, physical functioning, fatigue, dyspnea, FACT-An fatigue subscale, anemia subscale, and total score were selected for this analysis. Three models were developed for each PRO domain varying the parameterization of Hgb level: (1) change from baseline (continuous), (2) change from baseline (≥1.5 vs <1.5 g/dL), (3) absolute value (≥10 vs <10 g/dL). This was a post hoc analysis and not a prespecified endpoint of the COMMANDS study.1
Results from the QLQ-C30 in change from baseline in Hgb (continuous) included the following: Global Health Status/Quality of life: 2.43 (1.54, 3.31); Physical Functioning: 2.30 (1.49, 3.10); Fatigue: -3.20 (-4.24, -2.16); Dyspnea; -3.10 (-4.37, -1.83).1
Results from the FACT-An Fatigue Subscale include: 1.21 (0.97, 1.45) for change from baseline in Hgb (continuous); 1.42 (0.92, 1.91) for change from baseline in Hgb (≥1.5 vs <1.5 g/dL); and 1.29 (0.75, 1.83) for absolute Hgb (≥10 vs <10 g/dL). On the Anemia Subscale, results include: 1.54 (1.23, 1.84) for change from baseline in Hgb (continuous); 1.76 (1.13, 2.38) for change from baseline in Hgb (≥1.5 vs <1.5 g/dL); and 1.64 (0.96, 2.33) for absolute Hgb (≥10 vs <10 g/dL). For Total Score, results include: 2.66 (2.09, 3.23) for change from baseline in Hgb (continuous); 3.04 (1.88, 4.20) for change from baseline in Hgb (≥1.5 vs <1.5 g/dL); and 2.99 (1.72, 4.27) for absolute Hgb (≥10 vs <10 g/dL).1
CI=confidence interval; EHA=European Hematology Association; Hgb=hemoglobin; HRQoL=health-related quality of life; IPSS-R=Revised International Prognostic Scoring System; MDS=myelodysplastic syndromes; QLG=Quality of Life Group; QoL=quality of life; RS=ring sideroblast; SD=standard deviation; sEPO=serum erythropoietin.
