Recombinant human thrombopoietin (rhTPO) of different dosing regimens for refractory/relapsed primary immune thrombocytopenia: a multicenter, randomized controlled trial and pharmacokinetics study
Recombinant human TPO (rhTPO) is effective for refractory/relapsed primary immune thrombocytopenia (ITP), but optimal dosing regimen remains elusive. In this multicenter, randomized, controlled trial, a total of 282 adult ITP patients (mean age 47.3 years; 82 men) with a platelet count ≤30 × 109/L o...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-12-01
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| Series: | Platelets |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/09537104.2022.2157806 |
| _version_ | 1797684118340763648 |
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| author | Xiaofan Liu Yusheng Bai Tao Wang Yanping Song Feng Sun Ruixiang Xia Feiyue Zhu Jun Ma Quanyi Lu Xu Ye Xinrong Zhan Linjie Li Xinhong Guo Shuqin Cheng Yan Li Zhiqiang Guo Youhua Chen Shenxian Qian Ling Qin Qing Zhang Sunqiong Cao Renchi Yang |
| author_facet | Xiaofan Liu Yusheng Bai Tao Wang Yanping Song Feng Sun Ruixiang Xia Feiyue Zhu Jun Ma Quanyi Lu Xu Ye Xinrong Zhan Linjie Li Xinhong Guo Shuqin Cheng Yan Li Zhiqiang Guo Youhua Chen Shenxian Qian Ling Qin Qing Zhang Sunqiong Cao Renchi Yang |
| author_sort | Xiaofan Liu |
| collection | DOAJ |
| description | Recombinant human TPO (rhTPO) is effective for refractory/relapsed primary immune thrombocytopenia (ITP), but optimal dosing regimen remains elusive. In this multicenter, randomized, controlled trial, a total of 282 adult ITP patients (mean age 47.3 years; 82 men) with a platelet count ≤30 × 109/L or >30 × 109/L with active bleeding randomly received a once daily (QD) subcutaneous injection of 7500 U (n = 64) or 15000 U rhTPO for 14 injections, or 15000 U or 30000 U rhTPO once every other day (QOD) for 7 injections. The primary outcomes included change from baseline in platelet count and total response rate (TRR) on day 14. On day 14, the median increase of platelet count from baseline was the highest in the 15000-U QD group (167.5 × 109/L, interquartile range [IQR] 23.0–295.0 × 109/L), followed by the 30000-U QOD group (57.5 × 109/L, IQR 9.0–190.0 × 109/L) (ANCOVA P < .001; P = .266 with baseline count as a covariate). The TRR on day 14 was also the highest in the 15000-U QD group (63.2%), followed by the 30000-U QOD group (59.7%). The rate of grade 3 and above adverse events did not differ among the four groups. There were no new safety concerns. All 4 regimens are safe and well-tolerated. The 30000-U QOD regimen is practically indistinguishable in efficacy to the 15000-U QD regimen. |
| first_indexed | 2024-03-12T00:24:53Z |
| format | Article |
| id | doaj.art-289c4f91da7940189824cb7345fad1ef |
| institution | Directory Open Access Journal |
| issn | 0953-7104 1369-1635 |
| language | English |
| last_indexed | 2024-03-12T00:24:53Z |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Platelets |
| spelling | doaj.art-289c4f91da7940189824cb7345fad1ef2023-09-15T10:38:11ZengTaylor & Francis GroupPlatelets0953-71041369-16352023-12-0134110.1080/09537104.2022.21578062157806Recombinant human thrombopoietin (rhTPO) of different dosing regimens for refractory/relapsed primary immune thrombocytopenia: a multicenter, randomized controlled trial and pharmacokinetics studyXiaofan Liu0Yusheng Bai1Tao Wang2Yanping Song3Feng Sun4Ruixiang Xia5Feiyue Zhu6Jun Ma7Quanyi Lu8Xu Ye9Xinrong Zhan10Linjie Li11Xinhong Guo12Shuqin Cheng13Yan Li14Zhiqiang Guo15Youhua Chen16Shenxian Qian17Ling Qin18Qing Zhang19Sunqiong Cao20Renchi Yang21Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood DiseasesTraditional Chinese Medical Hospital of Xinjiang Uygur Autonomous RegionThe First Affiliated Hospital of Henan University of Chinese MedicineXi’an Central HospitalHeilongjiang University of Chinese MedicineThe First Affiliated Hospital of Anhui Medical UniversityLoudi Central HospitalHarbin Institute of Hematology and OncologyXiamen UniversityThe Second Affiliated Hospital of Guangzhou Medical UniversityXinxiang Central HospitalLishui Central HospitalThe First Affiliated Hospital of Xinjiang Medical UniversityGuangzhou Panyu Central HospitalThe First Hospital of China Medical UniversityZhengzhou Central HospitalRenmin Hospital of Wuhan University, Hubei General HospitalZhejiang University School of MedicineThe First Affiliated Hospital of Henan Technology UniversityGuangdong Second Provincial General HospitalShenyang Sunshine Pharmaceuticals Co. LtdChinese Academy of Medical Sciences & Peking Union Medical College, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood DiseasesRecombinant human TPO (rhTPO) is effective for refractory/relapsed primary immune thrombocytopenia (ITP), but optimal dosing regimen remains elusive. In this multicenter, randomized, controlled trial, a total of 282 adult ITP patients (mean age 47.3 years; 82 men) with a platelet count ≤30 × 109/L or >30 × 109/L with active bleeding randomly received a once daily (QD) subcutaneous injection of 7500 U (n = 64) or 15000 U rhTPO for 14 injections, or 15000 U or 30000 U rhTPO once every other day (QOD) for 7 injections. The primary outcomes included change from baseline in platelet count and total response rate (TRR) on day 14. On day 14, the median increase of platelet count from baseline was the highest in the 15000-U QD group (167.5 × 109/L, interquartile range [IQR] 23.0–295.0 × 109/L), followed by the 30000-U QOD group (57.5 × 109/L, IQR 9.0–190.0 × 109/L) (ANCOVA P < .001; P = .266 with baseline count as a covariate). The TRR on day 14 was also the highest in the 15000-U QD group (63.2%), followed by the 30000-U QOD group (59.7%). The rate of grade 3 and above adverse events did not differ among the four groups. There were no new safety concerns. All 4 regimens are safe and well-tolerated. The 30000-U QOD regimen is practically indistinguishable in efficacy to the 15000-U QD regimen.http://dx.doi.org/10.1080/09537104.2022.2157806dosing regimenefficacyimmune thrombocytopeniapharmacokineticsrecombinant human thrombopoietin |
| spellingShingle | Xiaofan Liu Yusheng Bai Tao Wang Yanping Song Feng Sun Ruixiang Xia Feiyue Zhu Jun Ma Quanyi Lu Xu Ye Xinrong Zhan Linjie Li Xinhong Guo Shuqin Cheng Yan Li Zhiqiang Guo Youhua Chen Shenxian Qian Ling Qin Qing Zhang Sunqiong Cao Renchi Yang Recombinant human thrombopoietin (rhTPO) of different dosing regimens for refractory/relapsed primary immune thrombocytopenia: a multicenter, randomized controlled trial and pharmacokinetics study Platelets dosing regimen efficacy immune thrombocytopenia pharmacokinetics recombinant human thrombopoietin |
| title | Recombinant human thrombopoietin (rhTPO) of different dosing regimens for refractory/relapsed primary immune thrombocytopenia: a multicenter, randomized controlled trial and pharmacokinetics study |
| title_full | Recombinant human thrombopoietin (rhTPO) of different dosing regimens for refractory/relapsed primary immune thrombocytopenia: a multicenter, randomized controlled trial and pharmacokinetics study |
| title_fullStr | Recombinant human thrombopoietin (rhTPO) of different dosing regimens for refractory/relapsed primary immune thrombocytopenia: a multicenter, randomized controlled trial and pharmacokinetics study |
| title_full_unstemmed | Recombinant human thrombopoietin (rhTPO) of different dosing regimens for refractory/relapsed primary immune thrombocytopenia: a multicenter, randomized controlled trial and pharmacokinetics study |
| title_short | Recombinant human thrombopoietin (rhTPO) of different dosing regimens for refractory/relapsed primary immune thrombocytopenia: a multicenter, randomized controlled trial and pharmacokinetics study |
| title_sort | recombinant human thrombopoietin rhtpo of different dosing regimens for refractory relapsed primary immune thrombocytopenia a multicenter randomized controlled trial and pharmacokinetics study |
| topic | dosing regimen efficacy immune thrombocytopenia pharmacokinetics recombinant human thrombopoietin |
| url | http://dx.doi.org/10.1080/09537104.2022.2157806 |
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