Dose-optimised recombinant human thrombopoietin versus eltrombopag in patients with immune thrombocytopenia: a multicenter, randomised controlled trial (The TE-ITP Study)

作者：Yunfei Chen, Ting Sun, Dawen Gao, Wei Wang, Zeping Zhou, Guangxun Gao, Yi Wang, Hu Zhou, Yanping Song, Yinghui Lai, Zhenyu Yan, Jinsong Yan, Jie Bai, Lei Zhang · 发表于：EClinicalMedicine · 年份：2025 · DOI：10.1016/j.eclinm.2025.103459 · 被引用次数：4 · 研究领域：Platelet Disorders and Treatments、Blood properties and coagulation、Trauma, Hemostasis, Coagulopathy, Resuscitation

Background Recombinant human thrombopoietin (rhTPO) at a fixed dose of 300 U/kg/day for 2 weeks has demonstrated good efficacy and safety in adults with immune thrombocytopenia (ITP). This trial aimed to develop a flexible and personalized rhTPO regimen that ensures efficacy and safety beyond previous fixed dose, with eltrombopag as an active comparator. Methods The TE-ITP trial was conducted in 12 centers across China. Adult ITP patients with platelet count <30 × 10 9 /L were randomised (2:1) to receive rhTPO or eltrombopag. The initial dose in patients with baseline platelet count of 20–30 × 10 9 /L versus <20 × 10 9 /L was 300 versus 600 U/kg/day for rhTPO and 25 versus 50 mg/day for eltrombopag, respectively. Dosage was adjusted weekly according to platelet count, with maximum of 600 U/kg/day for rhTPO and 75 mg/day for eltrombopag. The primary endpoint was the time to first platelet count ≥50 × 10 9 /L. The trial is registered on ClinicalTrials.gov (NCT05583838). Findings Between November 22, 2022 and January 16, 2024, the trial enrolled 157 patients (median age: 52 years; 104 women): 105 and 52 in the rhTPO and eltrombopag groups, respectively. Baseline platelet count was <20 × 10 9 /L in 57.1% (60/105) and 57.7% (30/52) in the rhTPO and eltrombopag groups, respectively. The median time to the first platelet count ≥50 × 10 9 /L was 7 days (95% CI 6.0–7.0) in the rhTPO group versus 15 days (95% CI 9.0–25.0) in the eltrombopag group ( p < 0.001). The risk of bleeding was ...