Novartis announced long-term study results supporting the positive safety and efficacy of Revolade (eltrombopag) in adults with chronic/persistent (enrolling patients that were 6 or more months from diagnosis) 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 (median exposure of 2.4 years).
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.
“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,” said lead author James Bussel, M.D., professor emeritus of pediatrics at Weill Cornell Medicine. “With this information, physicians can better optimize long-term disease management for appropriate patients living with this chronic disease.”
The efficacy results of EXTEND demonstrated that median platelet counts were elevated to >=50×109/L within two weeks of Revolade treatment, with median platelet counts >50×109/L maintained for more than four years. 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.
“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,” said Vas Narasimhan, M.D., Global Head Drug Development and Chief Medical Officer, Novartis. “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.”
Overall, the safety profile of Revolade was consistent with previous studies. The most common adverse events were headache (28%), nasopharyngitis (25%) and upper respiratory tract infection (23%). During treatment on EXTEND, 6% of patients experienced thromboembolic events.
Filed Under: Drug Discovery
