A Prospective Study to Evaluate the Efficacy, Safety and Response Duration of Newly Diagnosed Adult Immune Thrombocytopenia Patients Treated with Low Dose Rituximab and High Dose of Dexamethasone

Abstract

IntroductionPrimary immune thrombocytopenia (ITP) is an acquired autoimmune disorder that involves antibody and cell mediated destruction of platelets as well as suppression of their production. Corticosteroids are initial standard therapy in adults. Initially Rituximab (dose375mg/m2) was approved as one of the important second line therapy in chronic ITP. In the present prospective study, we will evaluate the efficacy, safety and response duration of low dose Rituximab (100mg) and high dose Dexamethasone as a front line therapy in new onset adult ITP cases.MethodsInj. Rituximab at a fixed dose of 100mg intravenous infusion for four doses (day 1,8,15,22) and Dexamethasone tablet 40 mg/daily PO for four days in a fifteen days' interval (day 1-4 and day 15-18). Response rate evaluated according to published guidelines.ResultsTotal no. of cases was 15. Male 5, female 10. Age range 18 to 62 years with median age of 36 years. Course completed in 15 patients. Median follow up of the patients was 6 months. Complete response (CR) was achieved after 1st dose of rituximab in 3 cases, 2 after 2nd dose and 4 after 4th dose of Rituximab. Partial response (PR) was achieved in 2 cases after completion of therapy and no response seen in 4 cases. Seven cases (46.66%) achieving CR maintaining sustained response after 6 months of completion of therapy. Two cases who achieved CR initially reverted to PR after 6 months with dropping of platelet count but without any evidence of bleeding symptoms. Minor side effects like GI intolerance, nausea, vomiting occurred in 3 patients, High blood sugar level during treatment seen in 2 patients and severe adverse effects like pneumonitis and intestinal obstruction seen in 2 patients who needed hospitalization. We did not observe any infusion related reaction.ConclusionsCR and PR rate was 60% (9/15) and 14%(2/15) respectively. Six months after completion of therapy 77.8% (7/9) showed sustained response after achieving CR. Low dose Rituximab and high dose Dexamethasone is a useful treatment option in adult acute ITP patients. DisclosuresNo relevant conflicts of interest to declare.