A multicenter randomized open-label study of rituximab plus rhTPO vs rituximab in corticosteroid-resistant or relapsed ITP

Abstract

Key Points• Rituximab plus recombinant human thrombopoietin is superior to rituximab monotherapy for corticosteroid-resistant or relapsed ITP patients.This study aimed to compare the efficacy and safety of rituximab (RTX) plus recombinant human thrombopoietin (rhTPO) with RTX alone in patients with immune thrombocytopenia (ITP) who had failed to respond to corticosteroids or relapsed. Recruited patients were randomized at a ratio of 2:1 into 2 groups: the combination group (RTX 1 rhTPO, n 5 77) and the monotherapy group (RTX, n 5 38). Overall response was achieved in 79.2% of patients in the combination group vs 71.1% in the monotherapy group (P 5 .36), and the complete response (CR) rate was 45.4% in the combination group compared with 23.7% in the monotherapy group (P 5 .026). The combination group had significantly shorter time to response (TTR; median and range, 7 and 4-28 days) compared with the monotherapy group (28 and 4-90 days) (P < .01). There was no difference between these 2 groups in terms of the long-term response (P 5 .12). Our findings demonstrated that the combination of RTX and rhTPO significantly increased the CR rate and shortened TTR compared with RTX monotherapy in the treatment of corticosteroid-resistant or relapsed ITP but failed to show a beneficial effect on the long-lasting response. This study is registered at www.clinicaltrials.gov as #NCT01525836. (Blood. 2015;125(10):1541-1547

A novel recombinant human thrombopoietin therapy for the management of immune thrombocytopenia in pregnancy

“…In previous studies, the most frequently reported adverse events of rhTPO are fever, upper respiratory infection, pain at injection site, dizziness, and so on. 14,23 The safety data in our study were consistent with previous reports. There was no new adverse event reported during the observation period and no adverse event-related study withdrawals.…”

“…Previous studies reported that 1% to 3% of patients with ITP were found to develop transient, lowtiter, and nonneutralized anti-TPO antibodies after multidosing, subcutaneous injection. 23,43 No anti-TPO antibodies were detected in our study, although the limited sample size precludes definitive conclusion.…”

“…Only mild previously reported adverse events were observed, including 1 case of dizziness, 1 of fatigue, and 1 of pain at injection site (Table 3). 14,23 There were no new adverse events reported during the observation period, and no adverse event-related study withdrawals. No obstetric conditions were reported.…”

An Idiopathic Thrombocytopenic Purpura Patient Treated With Homeopathy: A Case Report

“…Corticosteroid therapy is recommended as the first-line treatment [28], but the patient did not respond to prednisolone. As mentioned in some studies, a splenectomy may be recommended as another treatment [29,[31][32][33]; a splenectomy was not recommended as treatment in this case. Moreover, IVIg is prescribed for treatment as mentioned in some studies [30,31]; this patient did not respond to it.…”

“…At present, most treatment protocols concentrate on reducing platelet destruction, and the drugs are usually immunosuppressive [28]. Various treatment modalities applied to treat ITP are corticosteroid therapy [29,31,32], IVIg injection [30,31], splenectomy [29,[31][32][33], thrombopoietin receptor agonists (TPO-RAs) such as romiplostim, [29,31,32,34], and rituximab [29,32,35].…”