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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
Author(s) -
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 Xinguang,
Hou Ming
Publication year - 2020
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.25989
Subject(s) - medicine , dexamethasone , randomized controlled trial , clinical endpoint , clinical trial , adverse effect , prospective cohort study , gastroenterology
Abstract 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 < .001) and complete response (CR, 75.0% vs 42.7%, P < .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. This study is registered as clinicaltrials.gov identifier: NCT01734044.