Researchers from Italy have reported that the addition of Rituxan® (rituximab) to dexamethasone improves platelet responses in previously untreated patients with idiopathic immune thrombocytopenic purpura (ITP) compared with dexamethasone alone. The details of this study were presented in the Plenary Session of the annual meeting of the American Society of Hematology on December 7, 2008.[1]

Currently, approximately 140,000 patients are being treated for chronic ITP in the United States and Europe. The treatment goal for the management of ITP is often to achieve a hemostatic platelet count in order to reduce the risk of bleeding events. Patients with ITP suffer platelet destruction as well as the inability to compensate for low levels of platelets, resulting in dangerously low platelet levels. One of the standard treatments for ITP is dexamethasone. A recent Italian study suggested that Rituxan treatment results in long-term remissions in one-third of patients with refractory ITP.[2]

In the current study, 101 patients with previously untreated ITP were randomly allocated to be treated with dexamethasone alone or dexamethasone plus Rituxan. Patients who failed dexamethasone were allowed to cross over and receive Rituxan. All had platelet counts of 20,000 or lower, the median age was approximately 50 years, and women outnumbered men. Sixty-nine percent of patients receiving Rituxan achieved an initial platelet count of 50,000 or more compared with 31% in the dexamethasone alone group. This level of platelets was sustained in 85% of patients in the Rituxan group compared with 39% in the dexamethasone alone group. Sustained platelet levels of 100,000 or 150,000 were also greater in the Rituxan group than in the dexamethasone-alone group. More than half of the patients receiving salvage Rituxan also responded. Importantly, there were no increased toxicities in the Rituxan group.

Comments: This study clearly shows that Rituxan improves outcomes of newly diagnosed adult patients with ITP. These authors also suggest: “The long period of relapse free survival registered in some patients suggests a possible curative effect. This treatment can be offered as an option before splenectomy, particularly in those patients where the surgical option is not well accepted or have higher risk of complications.”

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