Details

Autor(en) / Beteiligte

• Zhou, Hai
• Xu, Miao
• Qin, Ping
• Zhang, Hai-yan
• Yuan, Cheng-lu
• Zhao, Hong-guo
• Cui, Zhong-guang
• Meng, Yue-sheng
• Wang, Lei
• Zhou, Fang
• Wang, Xin
• Li, Da-qi
• Bi, Ke-hong
• Zhu, Chuan-sheng
• Guo, Cheng-shan
• Chu, Xiao-xia
• Wu, Qing-chao
• Liu, Xin-guang
• Dong, Xiao-yuan
• Li, Jie
• Peng, Jun
• Hou, Ming

Titel

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

Ist Teil von

• Blood, 2015-03, Vol.125 (10), p.1541-1547

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2015

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. •Rituximab plus recombinant human thrombopoietin is superior to rituximab monotherapy for corticosteroid-resistant or relapsed ITP patients.