Novartis on Wednesday announced long-term study results supporting the positive safety and efficacy of Revolade in adults with chronic immune (idiopathic) thrombocytopenia (ITP) were published online in Blood.
The Extend study found that a majority of patients maintained a substantial clinical response and many no longer needed concomitant ITP medications. The research evaluated patients for up to 8 years of continuous treatment.
ITP is a rare and potentially serious blood disorder where the blood doesn’t clot as it should due to a low number of platelets. As a result, patients with ITP experience bruising, bleeding and, in rare cases, serious hemorrhaging that can be fatal. The goal of treatment in chronic/persistent ITP is to maintain a safe platelet count that reduces the risk of bleeding.
Lead author James Bussel, M.D., professor emeritus of pediatrics at Weill Cornell Medicine. ““The Extend data published in Blood validate Revolade as an important oral treatment option that, by often increasing platelet counts, significantly decreased bleeding rates and reduced the need for concurrent therapies in certain patients with chronic/persistent immune thrombocytopenia. With this information, physicians can better optimize long-term disease management for appropriate patients living with this chronic disease.”
The efficacy results of Extend showed that median platelet counts were elevated within two weeks of Revolade treatment. Post-baseline, overall bleeding rates declined and the majority of bleeding that occurred during the study was Grade 1 or 2 according to the World Health Organization bleeding scale. Some patients (39%) were capable of reducing or permanently stopping one or more concomitant ITP medications without the need for rescue therapy, many of which sustained reduction for at least 24 weeks.
Vas Narasimhan, Global Head Drug Development and Chief Medical Officer, Novartis. “We conducted this trial, the largest of its kind in adult patients, to ensure that clinicians have comprehensive data on hand as they work with their ITP patients to make treatment decisions. The EXTEND results reinforce Revolade as a trusted treatment option that can be used over the long-term for those living with this chronic and rare disease.”
Image: The logo of Swiss drugmaker Novartis is seen at its headquarters in Basel, Switzerland October 22, 2013. REUTERS/Arnd Wiegmann/File Photo