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Previous studies have shown that adding rituximab to dexamethasone increases response rate and duration of remission in patients with newly diagnosed primary immune thrombocytopenia (NEJM JW Oncol Hematol May 2013 and Blood 2013; 121:1976). Whether rituximab is effective as monotherapy in patients unresponsive to steroids has not been rigorously evaluated.
To examine the safety and effectiveness of rituximab in corticosteroid-refractory disease, investigators conducted a multicenter, randomized, double-blind, placebo-controlled trial involving 109 adult patients with platelet counts <30,000 per µL. Patients received 4 weekly infusions of either saline or rituximab (375 mg/m2), and any concomitant steroids were tapered to the lowest dose that…