Low-dose rituximab combined with short-term glucocorticoids up-regulates Treg cell levels in patients with immune thrombocytopenia.

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.