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首页> 外文期刊>British Journal of Haematology >Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia ( ITP ITP ) for up to 1?year and in those with chronic ITP ITP for more than 1?year: a subgroup analysis of integrated data from completed romiplostim studies
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Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia ( ITP ITP ) for up to 1?year and in those with chronic ITP ITP for more than 1?year: a subgroup analysis of integrated data from completed romiplostim studies

机译:成年患者的Romiplostim患者新诊断或持续的免疫血小板减少症(ITP ITP)最多1年,并在慢性ITP ITP的那些中超过1?一年:来自完成的romiplosim研究的综合数据亚组分析

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Summary The thrombopoietin receptor agonist romiplostim is approved for second‐line use in chronic immune thrombocytopenia ( ITP ), but its effects in patients with ITP for ≤1?year are not well characterized. This analysis of pooled data from 9 studies included patients with ITP for ≤1?year ( n? = ? 311) or 1?year ( n? = ? 726) who failed first‐line treatments and received romiplostim, placebo or standard of care. In subgroup analysis by ITP duration, patient incidences for platelet response at ≥75% of measurements were higher for romiplostim [ ITP ≤1?year: 74% (204/277); ITP 1?year: 71% (450/634)] than for placebo/standard of care [ ITP ≤1?year: 18% (6/34); ITP 1?year: 9% (8/92)]. Of patients with ≥9?months on study, 16% with ITP ≤1?year and 6% with ITP 1?year discontinued romiplostim and maintained platelet counts ≥50?×?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 or ITP 1?year, with more treatment‐free remission in those with ITP ≤1?year.
机译:发明内容血小板生成素受体激动剂romiplosim批准用于慢性免疫血小板减少症(ITP)的二线使用,但其对ITP患者的影响≤1Δ年并不具备很好的表征。这种分析来自9项研究的汇总数据包括ITP的患者≤1?一年(n?=?311)或& 1?一年(n?=?726)谁失败了一线处理,收到了romiplosim,安慰剂或标准护理。在STP持续时间的亚组分析中,对于≥75%的血小板反应的患者发泄≥75%的测量对于RomiplostimIm [ITP≤1'年份:74%(204/277); ITP& 1?年:71%(450/634)]比安慰剂/护理标准[ITP≤1吗?年:18%(6/34); ITP& 1?年:9%(8/92)]。 ≥9岁的患者研究,ITP≤1个月,16%,ITP& 1?一年停止的血小板计数≥50?×10 9 / L保持≥6?治疗(无处理缓解)。独立于ITP持续时间,严重不良事件和出血的率与RomiplosimIM低于安慰剂/护理标准,血栓形成事件以类似的速率发生。在这个分析中,Romiplosim和安慰剂/护理标准具有类似的安全性曲线和血小板计数患者的血小板计数,患者患者≤1?一年或ITP& 1?一年,在ITP≤1的那些中有更多的治疗缓解缓解?年。

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