Abstract:
While studies have explored the feasibility of switching between various thrombopoietin receptor agonists in treating immune thrombocytopenia (ITP), data on the switching from eltrombopag to hetrombopag remains scarce. This post-hoc analysis of a phase III hetrombopag trial aimed to assess the outcomes of ITP patients who switched from eltrombopag to hetrombopag. In the original phase III trial, patients initially randomized to the placebo group were switched to eltrombopag. Those who completed this 14-week eltrombopag were eligible to switch to a 24-week hetrombopag. Treatment response, defined as a platelet count of ≥ 50 × 109/L, and safety were evaluated before and after the switch. Sixty-three patients who completed the 14-week eltrombopag and switched to hetrombopag were included in this post-hoc analysis. Response rates before and after the switch were 66.7% and 88.9%, respectively. Among those with pre-switching platelet counts below 30 × 109/L, eight out of 12 patients (66.7%) responded, while eight out of nine patients (88.9%) with pre-switching platelet counts between 30 × 109/L and 50 × 109/L responded post-switching. Treatment-related adverse events were observed in 50.8% of patients during eltrombopag treatment and 38.1% during hetrombopag treatment. No severe adverse events were noted during hetrombopag treatment. Switching from eltrombopag to hetrombopag in ITP management appears to be effective and well-tolerated. Notably, hetrombopag yielded high response rates, even among patients who had previously shown limited response to eltrombopag. However, these observations need to be confirmed in future trials.
摘要:
虽然研究已经探索了在治疗免疫性血小板减少症(ITP)中在各种血小板生成素受体激动剂之间切换的可行性,有关从eltrombopag切换到hetrombopag的数据仍然很少。这项对III期hetrombopag试验的事后分析旨在评估从eltrombopag转换为hetrombopag的ITP患者的结局。在最初的III期试验中,最初随机分配至安慰剂组的患者改用艾曲波帕.那些完成了14周eltrombopag的人有资格改用24周的hetrombopag。治疗反应,定义为血小板计数≥50×109/L,在切换前后进行安全性评价。这项事后分析包括了63名完成了14周eltrombopag并改用hetrombopag的患者。切换前后的反应率分别为66.7%和88.9%,分别。在那些预转换血小板计数低于30×109/L的人中,12名患者中有8名(66.7%)有反应,而转换前血小板计数在30×109/L至50×109/L之间的9例患者中有8例(88.9%)在转换后有反应。在艾曲波帕治疗期间,50.8%的患者观察到与治疗相关的不良事件,在他曲波帕治疗期间观察到38.1%的患者。在hetrombopag治疗期间没有发现严重的不良事件。在ITP管理中从eltrombopag切换到hetrombopag似乎是有效且耐受性良好的。值得注意的是,hetrombopag产生高反应率,即使在以前对艾曲波帕的反应有限的患者中也是如此。然而,这些观察结果需要在未来的试验中得到证实.