This randomized trial was performed to investigate the efficacy of low-dose
rituximab in combination with
glucocorticoids for treatment of patients with
immune thrombocytopenia (
ITP). Sixty-two patients were randomly separated into the
glucocorticoids (control) and the experimental (glucocorticoids + rituximab) groups. Patients in both groups received
dexamethasone 40 mg/day on days 1-4, followed by decrements of
prednisone 60, 30, 15, 10 mg/day on days 5-7, 8-14, 15-21, 22-28, respectively. Patients in the experimental group also received
rituximab 100 mg on days 7, 14, 21, 28. The overall response (OR) was similar in both groups at day 28 (experimental group vs.
glucocorticoids group: 80.6 vs. 74.2%, P = .938); however, sustained response (SR) was more pronounced in the experimental group as compared to that in the
glucocorticoids group (77.4 vs. 38.7%, P < .001). Both groups showed similar incidence of adverse events (experimental group vs.
glucocorticoids group: 9.7 vs. 6.5%, P = .325). As expected, B cell depletion was seen in the experimental group. In addition, both groups experienced a significant up-regulation in Treg cell levels, but the up-regulation in the experimental group was maintained at an even higher level and persisted a longer time than those in the
glucocorticoids group. Thus, low-dose
rituximab combined with short-term
glucocorticoids provides an alternative treatment for
ITP prior to
splenectomy.