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首页> 外文期刊>Hematology >Effectiveness and safety of romiplostim among patients with newly diagnosed, persistent and chronic ITP in routine clinical practice in central and Eastern Europe: an analysis of the PLATON study
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Effectiveness and safety of romiplostim among patients with newly diagnosed, persistent and chronic ITP in routine clinical practice in central and Eastern Europe: an analysis of the PLATON study

机译：中东欧洲和东欧常规临床实践中新诊断，持续和慢性ITP患者患者的效力和安全性：柏拉图研究分析

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Objectives The objective of this analysis was to assess the effectiveness and safety of romiplostim in the real-world by duration of primary immune thrombocytopenia (ITP): 12 (‘chronic’) months. Methods This was a post-hoc analysis of the PLATON single-arm, observational cohort study of adults from five Central and Eastern European countries receiving ≥1 romiplostim dose as second-line therapy, or where surgery was contraindicated. Durable (≥75% of measurements with ≥50?×?10 9 platelets/L during weeks 14–24) and overall platelet response (≥30 or ≥50?×?10 9 platelets/L at least once), rescue therapy, bleeding, discontinuation of other ITP medications, and adverse drug reactions (ADRs) were assessed. Results Of 100 participants, 22.0% had newly diagnosed, 17.0% had persistent, and 61.0% had chronic ITP. Prior splenectomy was most frequently reported in chronic ITP (32.8%), prior bleeding was predominant in newly diagnosed patients (68.2%). Durable platelet response was achieved in 50.0% (95% confidence interval [CI]: 28.2–71.8%) of newly diagnosed, 35.3% (95% CI: 14.2–61.7%) of persistent, and 31.1% (95% CI: 19.9–44.3%) of chronic ITP patients. Overall platelet response was achieved in 80% across all strata. Safety was comparable across groups, with a low incidence of thrombotic ADRs and no bone marrow ADRs. Discussion In this real-world study, platelet response to romiplostim was consistent across all strata of ITP duration. ADRs were infrequent and similar across ITP settings. Conclusion These findings support the utilization of romiplostim in patients with newly diagnosed and persistent ITP in accordance with recent guidelines and the recent romiplostim label extension.
机译：目的这一分析的目的是通过原发性免疫血小板减少症（ITP）的持续时间来评估Romiplostim在现实世界中的有效性和安全性：12（'慢性'）月份。方法这是对柏拉图单臂，观察队伍的成年人的柏拉顿单臂，从五个中欧和东欧国家接受≥1个romiplosim剂量作为二线治疗，或者手术被禁止。耐用（≥75％的测量值≥50×14-24周，血小板响应（≥30或≥50Ω·0.×10 9个血小板/ l至少一次），救援治疗，评估出血，停止其他ITP药物和不良药物反应（ADR）。结果100名参与者，22.0％新诊断，17.0％持续存在，61.0％患有慢性ITP。在慢性ITP（32.8％）中最常见的脾切除术，在新诊断的患者（68.2％）中出现过突出。持久的血小板反应是在50.0％（95％置信区间[CI]：28.2-71.8％）的新诊断，35.3％（95％CI：14.2-61.7％）持续存在，31.1％（95％CI：19.9 -44.3％慢性ITP患者。整体血小板反应在所有地层上实现了80％。在组中，安全性相当，血栓形成ADR的发病率低，没有骨髓ADR。在这个真实研究中的讨论，对Romiplostim的血小板响应在ITP持续时间的所有地层上都是一致的。 ADR在ITP设置中不常见并类似。结论这些发现支持根据最近的准则和最近的romiplosim标签延伸，在新诊断和持久性ITP患者中使用Romiplostim。

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