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

Abstract

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 + rhTPO, n = 77) and the monotherapy group (RTX, n = 38). Overall response was achieved in 79.2% of patients in the combination group vs 71.1% in the monotherapy group (P = .36), and the complete response (CR) rate was 45.4% in the combination group compared with 23.7% in the monotherapy group (P = .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 = .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.

• Authors: Hai Zhou, Miao Xu, Ping Qin, Hai-yan Zhang, Cheng-lu Yuan, Hong-guo Zhao, Zhong-guang Cui, Yue-sheng Meng, Lei Wang, Fang Zhou, Xin Wang, Da-qi Li, Ke-hong Bi, Chuan-sheng Zhu, Cheng-shan Guo, Xiao-xia Chu, Qing-chao Wu, Xin-guang Liu, Xiao-yuan Dong, Jie Li, Jun Peng, Ming Hou
• Journal: Blood (Blood) Vol. 125 Issue 10 Pg. 1541-7 (Mar 05 2015) ISSN: 1528-0020 [Electronic] United States
• PMID: 25575541 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 by The American Society of Hematology.

Chemical References

• Adrenal Cortex Hormones
• Antibodies, Monoclonal, Murine-Derived
• Autoantibodies
• Recombinant Proteins
• Rituximab
• Thrombopoietin

Topics

• Adolescent
• Adrenal Cortex Hormones (therapeutic use)
• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal, Murine-Derived (administration & dosage, adverse effects)
• Autoantibodies (blood)
• Child
• Combined Modality Therapy
• Drug Resistance
• Female
• Humans
• Male
• Middle Aged
• Platelet Count
• Purpura, Thrombocytopenic, Idiopathic (blood, drug therapy, therapy)
• Recombinant Proteins (administration & dosage, adverse effects)
• Recurrence
• Rituximab
• Thrombopoietin (administration & dosage, adverse effects)
• Treatment Outcome
• Young Adult