Publications by authors named "Dimana Miteva"
To assess treatment patterns and outcomes in patients with non-del(5q) lower-risk myelodysplastic syndromes. Patient medical records were reviewed in the USA, Canada (CAN), UK and the EU. Analysis included 119 patients in the USA/CAN (median age, 61.
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- Patients with transfusion-dependent β-thalassemia often face health-related quality of life (HRQoL) issues due to long-term red blood cell transfusions leading to iron overload.
- The phase 3 BELIEVE trial studied the effects of luspatercept, an erythroid maturation agent, on HRQoL compared to a placebo, evaluating results at baseline and every 12 weeks using SF-36 and TranQol questionnaires.
- At week 48, while overall HRQoL scores remained stable for both groups, luspatercept patients who responded to treatment showed significant improvement in physical function compared to those on placebo.
Article Synopsis
- - The NTDT-PRO questionnaire was created to measure fatigue and shortness of breath among non-transfusion-dependent beta-thalassaemia patients, using data from the BEYOND trial to ensure its reliability and validity.
- - The trial involved 145 adults from several countries, assessing their symptoms and overall health through various scales over a 24-week period.
- - Results showed that the NTDT-PRO had strong internal consistency and test-retest reliability, with significant correlations between patients' T/W and SoB scores and their overall health and hemoglobin levels.
Red blood cell transfusion independence (RBC-TI) is an important goal in treating lower-risk myelodysplastic syndromes with ring sideroblasts. In the phase 3 MEDALIST study, RBC-TI of ≥ 8 weeks was achieved by significantly more luspatercept- versus placebo-treated patients in the first 24 weeks of treatment. In this post hoc analysis, we evaluated RBC transfusion units and visits based on patients' baseline transfusion burden level and the clinical benefit of luspatercept treatment beyond week 25 in initial luspatercept nonresponders (patients who did not achieve RBC-TI ≥ 8 weeks by week 25) but continued luspatercept up to 144 weeks.
View Article and Find Full Text PDFLuspatercept for the treatment of anaemia in non-transfusion-dependent β-thalassaemia (BEYOND): a phase 2, randomised, double-blind, multicentre, placebo-controlled trial.
Lancet Haematol
October 2022
Background: In patients with non-transfusion-dependent β-thalassaemia, haemoglobin concentrations lower than 10 g/dL are associated with a higher risk of morbidity, mortality, and impaired quality of life. No drugs are specifically approved for anaemia management in patients with non-transfusion-dependent β-thalassaemia, other than transfusion therapy administered infrequently in accordance with patients' needs. We assessed the efficacy and safety of luspatercept versus placebo in patients with non-transfusion-dependent β-thalassaemia.
View Article and Find Full Text PDFBackground: Patients with transfusion-dependent β-thalassemia need regular red-cell transfusions. Luspatercept, a recombinant fusion protein that binds to select transforming growth factor β superfamily ligands, may enhance erythroid maturation and reduce the transfusion burden (the total number of red-cell units transfused) in such patients.
Methods: In this randomized, double-blind, phase 3 trial, we assigned, in a 2:1 ratio, adults with transfusion-dependent β-thalassemia to receive best supportive care plus luspatercept (at a dose of 1.
Article Synopsis
- β-thalassemia is a genetic blood disorder characterized by inadequate production of hemoglobin, leading to chronic anemia and potential dependence on blood transfusions.
- Sotatercept, a treatment aimed at improving red blood cell production by blocking factors that hinder erythropoiesis, was tested in a phase II study involving 46 patients across several countries, with varying doses used over a period of up to 22 months.
- The results showed that Sotatercept was well tolerated, with significant improvements in hemoglobin levels for non-transfusion-dependent patients and a notable reduction in transfusion needs for transfusion-dependent patients.
Rationale: Lymphatic transport of peripheral interstitial fluid and dendritic cells (DCs) is important for both adaptive immunity and maintenance of tolerance to self-antigens. Lymphatic drainage can change rapidly and dramatically on tissue injury or inflammation, and therefore increased fluid flow may serve as an important early cue for inflammation; however, the effects of transmural flow on lymphatic function are unknown.
Objective: Here we tested the hypothesis that lymph drainage regulates the fluid and cell transport functions of lymphatic endothelium.