title: 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.affiliation: Department of Hematology, Qilu Hospital, Shandong University, Jinan, China;
authors.forename: Hai
authors.initials: H
authors.lastname: Zhou
authors.affiliation: Department of Hematology, Qilu Hospital, Shandong University, Jinan, China;
authors.forename: Miao
authors.initials: M
authors.lastname: Xu
authors.affiliation: Department of Hematology, Qilu Hospital, Shandong University, Jinan, China;
authors.forename: Ping
authors.initials: P
authors.lastname: Qin
authors.affiliation: Department of Hematology, Linyi People's Hospital, Linyi, China;
authors.forename: Hai-yan
authors.initials: HY
authors.lastname: Zhang
authors.affiliation: Department of Hematology, Qingdao Central Hospital, Qingdao, China;
authors.forename: Cheng-lu
authors.initials: CL
authors.lastname: Yuan
authors.affiliation: Department of Hematology, The Affiliated Hospital of Medical College, Qingdao University, Qingdao, China;
authors.forename: Hong-guo
authors.initials: HG
authors.lastname: Zhao
authors.affiliation: Department of Hematology, The Affiliated Hospital of Medical College, Qingdao University, Qingdao, China;
authors.forename: Zhong-guang
authors.initials: ZG
authors.lastname: Cui
authors.affiliation: Department of Hematology, Qingdao Municipal Hospital, Qingdao, China;
authors.forename: Yue-sheng
authors.initials: YS
authors.lastname: Meng
authors.affiliation: Department of Hematology, Qingdao Municipal Hospital, Qingdao, China;
authors.forename: Lei
authors.initials: L
authors.lastname: Wang
authors.affiliation: Department of Hematology, The General Hospital of Jinan Military Commanding Region, Jinan, China;
authors.forename: Fang
authors.initials: F
authors.lastname: Zhou
authors.affiliation: Department of Hematology, Provincial Hospital Affiliated to Shandong University, Jinan, China;
authors.forename: Xin
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Hematology, Shandong University Affiliated Jinan Center Hospital, Jinan, China;
authors.forename: Da-qi
authors.initials: DQ
authors.lastname: Li
authors.affiliation: Department of Hematology, Qianfoshan Hospital Affiliated to Shandong University, Jinan, China;
authors.forename: Ke-hong
authors.initials: KH
authors.lastname: Bi
authors.affiliation: Department of Hematology, Qianfoshan Hospital Affiliated to Shandong University, Jinan, China;
authors.forename: Chuan-sheng
authors.initials: CS
authors.lastname: Zhu
authors.affiliation: Department of Hematology, Second Hospital of Shandong University, Jinan, China;
authors.forename: Cheng-shan
authors.initials: CS
authors.lastname: Guo
authors.affiliation: Department of Hematology, Yantai Yuhuangding Hospital, Yantai, China;
authors.forename: Xiao-xia
authors.initials: XX
authors.lastname: Chu
authors.affiliation: Department of Hematology, Qingdao Haici Hospital, Qingdao, China; and.
authors.forename: Qing-chao
authors.initials: QC
authors.lastname: Wu
authors.affiliation: Department of Hematology, Qilu Hospital, Shandong University, Jinan, China;
authors.forename: Xin-guang
authors.initials: XG
authors.lastname: Liu
authors.affiliation: Department of Hematology, Qilu Hospital, Shandong University, Jinan, China;
authors.forename: Xiao-yuan
authors.initials: XY
authors.lastname: Dong
authors.affiliation: Department of Hematology, Qilu Hospital, Shandong University, Jinan, China;
authors.forename: Jie
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Hematology, Qilu Hospital, Shandong University, Jinan, China; Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education and Chinese Ministry of Health, Qilu Hospital, Shandong University, Jinan, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Peng
authors.affiliation: Department of Hematology, Qilu Hospital, Shandong University, Jinan, China; Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education and Chinese Ministry of Health, Qilu Hospital, Shandong University, Jinan, China.
authors.forename: Ming
authors.initials: M
authors.lastname: Hou
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage* / Q000009:adverse effects; D001323:Autoantibodies / Q000097:blood; D002648:Child; D003131:Combined Modality Therapy; D004351:Drug Resistance; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000097:blood / Q000188:drug therapy* / Q000628:therapy*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012008:Recurrence; D000069283:Rituximab; D013926:Thrombopoietin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D058846:Antibodies, Monoclonal, Murine-Derived; D001323:Autoantibodies; D011994:Recombinant Proteins; D000069283:Rituximab; D013926:Thrombopoietin