Exjade(R) Benefits Chronically Transfused Patients by Significantly Reducing Toxic Iron That Can Damage Key Organs, According to Land...( A pre-planned analysis of 341 MDS p...),Health

A pre-planned analysis of 341 MDS patients enrolled in the study showed that Exjade significantly reduced levels of serum ferritin (SF), a key measure of iron in the body, by 253.0 ng/mL from baseline (P=0.0019). Of the 171 MDS patients whose SF was measured at one year, the decrease from baseline was 606 ng/mL.

"Many MDS patients receive regular blood transfusions as part of their ongoing treatment, which puts them at risk for iron overload," said Norbert Gattermann, MD, PhD, Hematology, Oncology and Clinical Immunology, Heinrich Heine University Medical Center, Dusseldorf, Germany. "This study, which includes the largest number of MDS patients of any iron chelation study, shows deferasirox can effectively reduce iron burden and is generally well tolerated when used appropriately to treat these patients."

Iron toxicity can lead to permanent damage of the liver, heart and endocrine glands, leading to an increased risk of serious health problems and early death. Previous studies of transfusion-dependent MDS patients have found that increased levels of SF are associated with shortened overall survival.

About the EPIC trial

The EPIC trial was a one-year, open-label, prospective, multicenter trial. EPIC studied the efficacy and safety of a fixed starting dose of Exjade based on transfusional iron intake, with subsequent dose titration at 3-monthly intervals based on serum ferritin (SF) trends. With 1,744 patients, this trial is the largest ever conducted for an iron chelator and included the largest cohorts of underlying anemias in a single trial, including patients with beta-thalassemia, MDS and aplastic anemia. Twelve abstracts from EPIC are being presented at ASH.

Study details

The EPIC cardiac substudy evaluated the cardiac efficacy of Exjade in 114 beta-thalassemia patients with myocardial siderosis (T2* <20 ms). Baselin
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