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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| Authors: | Yafei Yu Miaomiao Wang Yu Hou Ping Qin Qingshu Zeng Wenzheng Yu Xinhong Guo Jingxia Wang Xiaomin Wang Guoqiang Liu Xiaoxia Chu Lan Yang Ying Feng Fang Zhou Zhaogang Sun Mei Zhang Xin Wang Zhencheng Wang Xuehong Ran Hongguo Zhao Lei Wang Haiyan Zhang Kehong Bi Daqi Li Chenglu Yuan Ruirong Xu Yili Wang Yuhong Zhou Jun Peng Xin-guang Liu Ming Hou |
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| Affiliation: | 1. Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China;2. Department of Pediatrics, The Second Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China;3. Department of Hematology, The First Affiliated Hospital of Anhui Medical University, Hefei, China;4. Department of Hematology, Binzhou Medical University Hospital, Binzhou, China;5. Department of Hematology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China;6. Department of Hematology, Liaocheng People’s Hospital, Liaocheng, China;7. Department of Hematology, Xinjiang Uiger Municipal People’s Hospital, Urumqi, China;8. Department of Hematology, Shengli Oilfield Central Hospital, Dongying, China;9. Department of Hematology, Yantai Yuhuangding Hospital, Yantai, China;10. Department of Hematology, Xijing Hospital, Fourth Military Medical University, Xi’an, China;11. Department of Hematology, The Second Affiliated Hospital of Guangzhou Medical University, Guangdong, China;12. Department of Hematology, Military General Hospital, Jinan, China;13. Department of Hematology, Taian City Central Hospital, Taian, China;14. Department of Hematology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China;15. Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China;16. Department of Hematology, Zibo Central Hospital, Zibo, China;17. Department of Hematology, Weifang People’s Hospital, Weifang, China;18. Department of Hematology, The Affiliated Hospital of Qingdao University, Qingdao, China;19. Department of Hematology, Qingdao Municipal Hospital, Qingdao, China;20. Department of Hematology, Linyi People’s Hospital, Linyi, China;21. Department of Hematology, Shandong Provincial Qianfoshan Hospital, Jinan, China;22. Department of Hematology, Jinan Central Hospital, Jinan, China;23. Department of Hematology, Qilu Hospital (Qingdao), Shandong University, Qingdao, China;24. Department of Hematology, Shandong Provincial Hospital of Traditional Chinese Medicine, Jinan, China;25. Department of Hematology, Weihai Municipal Hospital, Weihai, China;26. Department of Hematology, Zhejiang Provincial Hospital of TCM, Hangzhou, China |
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| 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. |
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