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Dose tapering to withdrawal stage and long-term efficacy and safety of hetrombopag for the treatment of immune thrombocytopenia: Results from an open-label extension study.

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机构： [1]Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [2]Thrombosis and Hemostasis Center, State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Tianjin Laboratory of Blood Disease Gene Therapy, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. [3]Department of Hematology, Institute of Hematology, West China Hospital, Sichuan University, Chengdu, China. [4]Department of Hematology, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. [5]Department of Hematopathology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [6]The Blood Internal Medicine, The First Affiliated Hospital of Air Force Medical University, Xi'an, China. [7]Hematology Department, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. [8]Hematology Department, The First Affiliated Hospital of Nanchang University, Nanchang, China. [9]Department of Hematology, The Second Hospital of Shanxi Medical University, Taiyuan, China. [10]Hematology, Fujian Medical University Union Hospital, Fuzhou, China. [11]Department of Hematology, Qilu Hospital, Shandong University, Jinan, China. [12]Hematology Department, Baoji Central Hospital, Baoji, China. [13]Department of Hematopathology, The Second Affiliated Hospital of Air Force Medical University, Xi'an, China. [14]Department of Hematopathology, Shaanxi Provincial People's Hospital, Xi'an, China. [15]Hematology Department, The First Affiliated Hospital of Soochow University, Suzhou, China. [16]Hematology Department, Lanzhou University Second Hospital, Lanzhou, China. [17]Hematology Department, The First Affiliated Hospital of USTC, Hefei, China. [18]Department of Hematology, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, China. [19]Department of Hematology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, China. [20]Hematology, The Third Xiangya Hospital of Central South University, Changsha, China. [21]Department of Hematology, The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, China. [22]Department of Hematology, The Second Hospital of Hebei Medical University, Shijiazhuang, China. [23]Department of Hematology, First Affiliated Hospital of Kunming Medical University, Kunming, China. [24]Hematology, The First Hospital of Jilin University, Changchun, China. [25]Department of Hematology, Peking University People's Hospital, Beijing, China. [26]Hematology Department, Wuxi People's Hospital, Wuxi, China. [27]Hematology Department, The Second Affiliated Hospital of Nanchang University, Nanchang, China. [28]Hematology Department, The First Affiliated Hospital of Anhui Medical University, Hefei, China. [29]Hematology Department, The First People's Hospital of Changzhou, Changzhou, China. [30]Department of Hematology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [31]Department of Hematology, The Second Affiliated Hospital of Military Medical University PLA, Chongqing, China. [32]Hematology & Oncology, China-Japan Union Hospital of Jilin University, Changchun, China. [33]Hematology Department, The First Hospital of China Medical University, Shenyang, China. [34]Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.

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The efficacy of hetrombopag in Chinese patients with immune thrombocytopenia (ITP) has been demonstrated in a randomized, double-blind, placebo-controlled, multicenter, phase III trial (NCT03222843).This study aimed to report comprehensive data on a ≤6-week dose tapering to withdrawal (Stage 3) and an additional 24-week long-term extension period (Stage 4) in this phase III trial.Patients who fulfilled the screening criteria were eligible to enter Stage 3 or 4. During Stage 3, hetrombopag was gradually tapered to withdrawal. During Stage 4, hetrombopag treatment was initiated at 2.5, 3.75, 5, or 7.5 mg once daily. The efficacy endpoints during Stage 3 or 4 and the safety profile during the entire treatment period were reported.Among 194 patients who entered Stage 3, 171 (88.1%) relapsed. The median time to the first relapse since the start of Stage 3 was 15.0 days (95% CI, 14.0-16.0). In Stage 4, 144 (42.5%) patients responded at ≥75% of their assessments and 254 (74.9%) patients achieved platelet count ≥30 × 109 /L at least once, which was at least twice their baseline platelet count in the hetrombopag group (n = 339). The most common adverse events were upper respiratory tract infection (53.1%), thrombocytopenia (27.1%), and urinary tract infection (21.2%) in the hetrombopag group.The majority of patients who experienced dose tapering to withdrawal experienced a relapse. Long-term treatment with hetrombopag was effective in increasing and maintaining platelet count within the desired range in Chinese adults with ITP. Hetrombopag was well tolerated.© 2021 International Society on Thrombosis and Haemostasis.

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出版当年[2021]版：

大类 | 2 区医学

小类 | 2 区血液学 2 区外周血管病

最新[2023]版：

大类 | 2 区

医学

小类 | 2 区血液学 2 区外周血管病

第一作者：

第一作者机构： [1]Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

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通讯作者：

通讯机构： [1]Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [2]Thrombosis and Hemostasis Center, State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Tianjin Laboratory of Blood Disease Gene Therapy, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. [3]Department of Hematology, Institute of Hematology, West China Hospital, Sichuan University, Chengdu, China. [*1]Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430000, China. [*2]Thrombosis and Hemostasis Center, State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin Laboratory of Blood Disease Gene Therapy, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Tianjin 300020, China. [*3]Department of Hematology, Institute of Hematology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.

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