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MabThera Significantly Reduces Risk of Serious Bleeding in People With Life-Threatening Autoimmune Disorder
Basel, Switzerland (ots/PRNewswire) -
- For Non-US and Non-UK Media Only
- Abstract Number: 1
- New Phase III Data Suggest Potential Role for MabThera in Treating Blood Disorder
New data presented at the 50th Annual Meeting of the American Society of Hematology (ASH) today, show that people living with a previously untreated bleeding disorder, idiopathic thrombocytopenic purpura (ITP), who received MabThera (rituximab) in combination with standard management were able to prevent bleeding for longer than those receiving standard treatment alone.
Data from the phase III study, which is the first randomised study to evaluate the use of MabThera in treating platelet disorders, shows that patients with ITP who were given MabThera and standard treatment were able to maintain their blood platelet count for longer thereby avoiding potentially life threatening bleeding in vital organs such as the brain.
"People with chronic ITP and very low platelet counts live with the threat of bleeding. The aim of treatment is to stop blood platelet counts falling to help prevent this from happening. These data show that patients receiving MabThera experience an immediate benefit" said Francesco Zaja from the University of Udine, Italy, and principle investigator for the study.
ITP is an autoimmune disease in which the body attacks its own blood cells (platelets) or does not produce enough blood cells to protect itself. This means the blood does not clot properly and can result in easy bruising, nose bleeds, bleeding from the gums, gut, and bleeding in the brain. ITP is either an acute condition in children or a chronic condition in adults. Chronic ITP predominantly affects adults (median age around 50 years) and is more common in women.
"The long period of time without the disease recurring shows that in some patients MabThera offers the potential for cure," said Francesco Zaja. "This is extremely good news for people with this potentially life-threatening condition as current forms of treatment only aim to relieve symptoms rather than cure the condition itself."
About the study
The study is a phase III study designed to assess the monoclonal antibody MabThera in combination with oral corticosteroid dexamethasone in adult patients with previously untreated ITP. 101 patients previously untreated for ITP with a blood platelet count of less than 20 x 10 to the power of 9/L were involved in the study, which was conducted between July 2005 and June 2007. Of these, 49 patients received MabThera in combination with dexamethasone and 52 patients received dexamethasone alone. The primary endpoint was sustained response rate, i.e. a blood platelet count of more than 50 x 10 to the power of 9/L after six months. The results were analysed by an intention to treat (ITT) and by a per protocol (PP) analysis.
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