P102 A multi-center, open label study evaluating the efficacy of iron chelation therapy with deferasirox in transfusional iron overload patients with myelodysplastic syndromes or aplastic anemia using quantitative R2 MRI

Min, Yoo Hong; Cheong, June‐Won; Kim, H.; Lee, K.; Yoon, Sung‐Soo; Lee, J.; Park, H.; Shim, Hyo Sup; Seung, Chu-Myung; Kim, C.; Chung, Jae Ho; Hyun, Myung Chul; Jo, Deog‐Yeon; Jung, Chul Ho

doi:10.1016/s0145-2126(09)70183-3

Cited by 8 publications

(5 citation statements)

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“…12,14 These findings have been confirmed in this large study of 116 iron-overloaded patients with AA, in which 1 year of treatment with deferasirox resulted in a statistically significant and clinically relevant reduction in serum ferritin levels that was reflective of dose adjustments and mean iron intake during the study. Baseline serum ferritin levels and the reduction in serum ferritin over the 1-year treatment period were similar in patients who received average actual deferasirox doses of less than 20 mg/kg per day or more than or equal to 20 to less than 30 mg/kg per day.…”

Section: Discussionmentioning

confidence: 59%

“…The effectiveness of deferasirox in reducing or maintaining body iron has been demonstrated in studies involving large numbers of patients with a variety of transfusion-dependent anemias. 12,13 Earlier clinical studies of deferasirox have included smaller populations of patients with AA (n ϭ 5 12 and n ϭ 50 14 ). The largest number of patients with AA ever included in an iron chelator trial (n ϭ 116) were enrolled in the large prospective, multicenter, 1-year Evaluation of Patients' Iron Chelation with Exjade (EPIC) study.…”

Section: Introductionmentioning

confidence: 99%

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Iron chelation therapy with deferasirox in patients with aplastic anemia: a subgroup analysis of 116 patients from the EPIC trial

Lee

Yoon²,

Shen

et al. 2010

Blood

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The prospective 1-year Evaluation of Patients' Iron Chelation with Exjade (EPIC) study enrolled a large cohort of 116 patients with aplastic anemia; the present analyses evaluated the efficacy and safety of deferasirox in this patient population. After 1 year, median serum ferritin decreased significantly from 3254 ng/mL at baseline to 1854 ng/mL (P < .001). Decreases occurred in chelation-naive (3229-1520 ng/mL; P < .001, last-observation-carried-forward analysis), and previously chelated (3263-2585 ng/mL; P ‫؍‬ .21, last-observationcarried-forward analysis) patients and were reflective of dose adjustments and ongoing iron intake. Baseline labile plasma iron levels were within normal range despite high serum ferritin levels. The most common drug-related adverse events were nausea (22%) and diarrhea (16%). Serum creatinine increases more than 33% above baseline and the upper limit of normal occurred in 29 patients (25%), but there were no progressive increases; concomitant use of cyclosporine had a significant impact on serum creatinine levels. The decrease in mean alanine aminotransferase levels at 1 year correlated significantly with reduction in serum ferritin (r ‫؍‬ 0.40, P < .001). Mean absolute neutrophil and platelet counts remained stable during treatment, and there were no drug-related cytopenias. This prospective dataset confirms the efficacy and well characterizes the tolerability profile of deferasirox in a large population of patients with aplastic anemia. This study was registered at www.clinicaltrials. gov as #NCT00171821. (Blood. 2010;116(14):2448-2454)

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Section: Discussionmentioning

confidence: 59%

Section: Introductionmentioning

confidence: 99%

Iron chelation therapy with deferasirox in patients with aplastic anemia: a subgroup analysis of 116 patients from the EPIC trial

Lee

Yoon²,

Shen

et al. 2010

Blood

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“…5 ) study (n=116). A post hoc analysis of hematologic responses was conducted on 72 patients with evaluable hematologic parameters (according to UK guideline criteria), 24 of whom received deferasirox without concomitant immunosuppressive treatment.…”

Section: Design and Methodsmentioning

confidence: 99%

“…3 Studies of iron chelation therapy in patients with AA have mainly focused on efficacy in reducing tissue iron and safety. [3][4][5][6] However, reports are now emerging of hematologic improvements associated with iron chelation therapy in patients with AA. [7][8][9][10] As iron overload also has a suppressive effect on erythroid progenitors 11 and may increase transfusion requirements, 12 it is of interest to evaluate hematologic responses in patients with AA receiving iron chelation therapy.…”

Section: Introductionmentioning

confidence: 99%

Hematologic responses in patients with aplastic anemia treated with deferasirox: a post hoc analysis from the EPIC study

et al. 2013

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“…Several studies have demonstrated the efficacy of deferasirox in maintaining or reducing body iron burden in patients with MDS 22,31,45–48. As in the β-thalassemia population, deferasirox has dose-dependent efficacy in patients with MDS 22.…”

Section: Efficacy Of Deferasiroxmentioning

confidence: 99%

Update on the use of deferasirox in the management of iron overload

Taher

Cappellini

2009

TCRM

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Regular blood transfusions as supportive care for patients with chronic anemia inevitably lead to iron overload as humans cannot actively remove excess iron. The cumulative effects of iron overload cause significant morbidity and mortality if not effectively treated with chelation therapy. Based on a comprehensive clinical development program, the once-daily, oral iron chelator deferasirox (Exjade®) is approved for the treatment of transfusional iron overload in adult and pediatric patients with various transfusion-dependent anemias, including β-thalassemia and the myelodysplastic syndromes. Deferasirox dose should be titrated for each individual patient based on transfusional iron intake, current iron burden and whether the goal is to decrease or maintain body iron levels. Doses of >30 mg/kg/day have been shown to be effective with a safety profile consistent with that observed at doses <30 mg/kg/day. Recent data have highlighted the ability of deferasirox to decrease cardiac iron levels and to prevent the accumulation of iron in the heart. The long-term efficacy and safety of deferasirox for up to 5 years of treatment have now been established. The availability of this effective and generally well tolerated oral therapy represents a significant advance in the management of transfusional iron overload.

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P102 A multi-center, open label study evaluating the efficacy of iron chelation therapy with deferasirox in transfusional iron overload patients with myelodysplastic syndromes or aplastic anemia using quantitative R2 MRI

Cited by 8 publications

References 0 publications

Iron chelation therapy with deferasirox in patients with aplastic anemia: a subgroup analysis of 116 patients from the EPIC trial

Iron chelation therapy with deferasirox in patients with aplastic anemia: a subgroup analysis of 116 patients from the EPIC trial

Hematologic responses in patients with aplastic anemia treated with deferasirox: a post hoc analysis from the EPIC study

Update on the use of deferasirox in the management of iron overload

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