Novartis report real-world data for ITP drug Revolade

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Novartis has reported results of a retrospective, real-world evidence study in patients with immune thrombocytopenia (ITP) treated with Revolade (eltrombopag), compared to other second-line therapies.

The data showed that patients experienced better clinical outcomes with Revolade, in terms of fewer bleeding episodes.

“Despite advances in treating immune thrombocytopenia, many patients remain at risk for bleeding episodes,” said Samit Hirawat, Head, Novartis Oncology Global Drug Development. “

With these kind of real-world data, we can reimagine care by more clearly understanding the outcomes of a range of treatments and, in turn, helping healthcare providers better navigate available options with their patients.”

Electronic health records (EHR) data from January 1, 2009 to September 30, 2016 from the Optum EHR database were used to evaluate the effect of second-line agents for ITP.

Identified patients had the following characteristics: 18 years or older, evidence of previous treatment with steroids or immune globulin products, and activity in the database for at least 6 months prior to and 12 months post initiation of a second-line agent.

Treatment outcomes evaluated included platelet counts, bleeding related episodes (BREs), and thrombotic events (TEs) over the 12-month period following starting a second-line therapy.

“These real-world data can help doctors as they weigh options for second-line therapy with their patients,” said Adam Cuker, Assistant Professor of Medicine at the University of Pennsylvania.

“They may also help explain the long-term trend toward deferring splenectomies until after other lines of treatment have been tried.”

Immune thrombocytopenia is a rare and potentially serious blood disorder where there is an increased risk of bleeding due to a low number of platelets. As a result, patients with ITP experience bruising, bleeding and, in rare cases, serious hemorrhage 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.