High‐dose dexamethasone plus recombinant human thrombopoietin vs high‐dose dexamethasone alone as frontline treatment for newly diagnosed adult primary immune thrombocytopenia: A prospective, multicenter, randomized trial

We conducted a prospective, multicenter, randomized, controlled clinical trial to compare the efficacy and safety of high‐dose dexamethasone (HD‐DXM) plus recombinant human thrombopoietin (rhTPO), vs HD‐DXM alone in newly diagnosed adult immune thrombocytopenia (ITP) patients. Enrolled patients were...

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Published in:American journal of hematology 2020-12, Vol.95 (12), p.1542-1552
Main Authors: Yu, Yafei, Wang, Miaomiao, Hou, Yu, Qin, Ping, Zeng, Qingshu, Yu, Wenzheng, Guo, Xinhong, Wang, Jingxia, Wang, Xiaomin, Liu, Guoqiang, Chu, Xiaoxia, Yang, Lan, Feng, Ying, Zhou, Fang, Sun, Zhaogang, Zhang, Mei, Wang, Xin, Wang, Zhencheng, Ran, Xuehong, Zhao, Hongguo, Wang, Lei, Zhang, Haiyan, Bi, Kehong, Li, Daqi, Yuan, Chenglu, Xu, Ruirong, Wang, Yili, Zhou, Yuhong, Peng, Jun, Liu, Xin‐guang, Hou, Ming
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Language:English
Subjects:
Dexamethasone
Hematology
Idiopathic thrombocytopenic purpura
Immunosuppressive agents
Patients
Steroids
Thrombocytopenia
Thrombopoietin
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cited_by cdi_FETCH-LOGICAL-c3659-c76770a1dc9a109599dccf6f89f2dfe037c712bbb4289ceb8122127614c8a1b43
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creator Yu, Yafei
Wang, Miaomiao
Hou, Yu
Qin, Ping
Zeng, Qingshu
Yu, Wenzheng
Guo, Xinhong
Wang, Jingxia
Wang, Xiaomin
Liu, Guoqiang
Chu, Xiaoxia
Yang, Lan
Feng, Ying
Zhou, Fang
Sun, Zhaogang
Zhang, Mei
Wang, Xin
Wang, Zhencheng
Ran, Xuehong
Zhao, Hongguo
Wang, Lei
Zhang, Haiyan
Bi, Kehong
Li, Daqi
Yuan, Chenglu
Xu, Ruirong
Wang, Yili
Zhou, Yuhong
Peng, Jun
Liu, Xin‐guang
Hou, Ming
description We conducted a prospective, multicenter, randomized, controlled clinical trial to compare the efficacy and safety of high‐dose dexamethasone (HD‐DXM) plus recombinant human thrombopoietin (rhTPO), vs HD‐DXM alone in newly diagnosed adult immune thrombocytopenia (ITP) patients. Enrolled patients were randomly assigned to receive DXM plus rhTPO or DXM monotherapy. Another 4‐day course of DXM was repeated if response was not achieved by day 10 in both arms. One hundred patients in the HD‐DXM plus rhTPO arm and 96 patients in the HD‐DXM monotherapy arm were included in the full analysis set. So, HD‐DXM plus rhTPO resulted in a higher incidence of initial response (89.0% vs 66.7%, P 
doi_str_mv 10.1002/ajh.25989
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Enrolled patients were randomly assigned to receive DXM plus rhTPO or DXM monotherapy. Another 4‐day course of DXM was repeated if response was not achieved by day 10 in both arms. One hundred patients in the HD‐DXM plus rhTPO arm and 96 patients in the HD‐DXM monotherapy arm were included in the full analysis set. So, HD‐DXM plus rhTPO resulted in a higher incidence of initial response (89.0% vs 66.7%, P &lt; .001) and complete response (CR, 75.0% vs 42.7%, P &lt; .001) compared with HD‐DXM monotherapy. Response rate at 6 months was also higher in the HD‐DXM plus rhTPO arm than that in the HD‐DXM monotherapy arm (51.0% vs 36.5%, P = .02; sustained CR: 46.0% vs 32.3%, P = .043). Throughout the follow‐up period, the overall duration of response was greater in the HD‐DXM plus rhTPO arm compared to the HD‐DXM monotherapy arm (P = .04), as estimated by the Kaplan‐Meier analysis. The study drugs were generally well tolerated. In conclusion, the combination of HD‐DXM with rhTPO significantly improved the initial response and yielded favorable SR in newly diagnosed ITP patients, thus could be further validated as a frontline treatment for ITP. 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Enrolled patients were randomly assigned to receive DXM plus rhTPO or DXM monotherapy. Another 4‐day course of DXM was repeated if response was not achieved by day 10 in both arms. One hundred patients in the HD‐DXM plus rhTPO arm and 96 patients in the HD‐DXM monotherapy arm were included in the full analysis set. So, HD‐DXM plus rhTPO resulted in a higher incidence of initial response (89.0% vs 66.7%, P &lt; .001) and complete response (CR, 75.0% vs 42.7%, P &lt; .001) compared with HD‐DXM monotherapy. Response rate at 6 months was also higher in the HD‐DXM plus rhTPO arm than that in the HD‐DXM monotherapy arm (51.0% vs 36.5%, P = .02; sustained CR: 46.0% vs 32.3%, P = .043). Throughout the follow‐up period, the overall duration of response was greater in the HD‐DXM plus rhTPO arm compared to the HD‐DXM monotherapy arm (P = .04), as estimated by the Kaplan‐Meier analysis. The study drugs were generally well tolerated. In conclusion, the combination of HD‐DXM with rhTPO significantly improved the initial response and yielded favorable SR in newly diagnosed ITP patients, thus could be further validated as a frontline treatment for ITP. 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subjects Dexamethasone
Hematology
Idiopathic thrombocytopenic purpura
Immunosuppressive agents
Patients
Steroids
Thrombocytopenia
Thrombopoietin
title High‐dose dexamethasone plus recombinant human thrombopoietin vs high‐dose dexamethasone alone as frontline treatment for newly diagnosed adult primary immune thrombocytopenia: A prospective, multicenter, randomized trial
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