Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies

Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies
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DOI:
10.1111/bjh.15803
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发表时间:
2019-05-01
影响因子:
6.5
通讯作者:
Eisen, Melissa
Eisen, Melissa
中科院分区:
医学2区
文献类型:
--
作者:
Kuter, David J.;Newland, Adrian;Eisen, Melissa

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血小板生成素受体激动剂romiplostim已获批用于慢性免疫性血小板减少症(ITP)的二线治疗,但对于≥ 75%的测量值,romiplostim对ITP患者的影响[ITP 1年:71%(450/634)]高于安慰剂/标准治疗[ITP 1年:9%(8/92)]。在研究时间≥ 9个月的患者中,16%的ITP 1年患者停用romiplostim,并在未接受ITP治疗的情况下维持血小板计数≥ 50 x 10(9)/l ≥ 6个月(无治疗缓解)。与ITP持续时间无关,romiplostim的严重不良事件和出血发生率低于安慰剂/标准治疗,血栓形成事件的发生率相似。在这项分析中,romiplostim和安慰剂/标准治疗具有相似的安全性特征,romiplostim增加了ITP 1年患者的血小板计数,ITP患者的无治疗缓解率更高
The thrombopoietin receptor agonist romiplostim is approved for second-line use in chronic immune thrombocytopenia (ITP), but its effects in patients with ITP for = 75% of measurements were higher for romiplostim [ITP 1 year: 71% (450/634)] than for placebo/standard of care [ITP 1 year: 9% (8/92)]. Of patients with >= 9 months on study, 16% with ITP 1 year discontinued romiplostim and maintained platelet counts >= 50 x 10(9)/l for >= 6 months without ITP treatment (treatment-free remission). Independent of ITP duration, rates of serious adverse events and bleeding were lower with romiplostim than placebo/standard of care and thrombotic events occurred at similar rates. In this analysis, romiplostim and placebo/standard of care had similar safety profiles and romiplostim increased platelet counts in patients with either ITP 1 year, with more treatment-free remission in those with ITP