Romiplostim for Primary Immune Thrombocytopenia in Routine Clinical Practice: Results from a Multicentre Observational Study in Germany.
Romiplostim for Primary Immune Thrombocytopenia in Routine Clinical Practice: Results from a Multicentre Observational Study in Germany.
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DOI：
10.1159/000521689
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发表时间：
2022
影响因子：
2.4
通讯作者：
Welslau, Manfred
中科院分区：
文献类型：
--
作者：
Reiser, Marcel;Josten, Klaus M.;Dietzfelbinger, Hermann;Seesaghur, Anouchka;Schill, Markus;Hippenmeyer, Jane;Welslau, Manfred
关键词：
romiplostim 的有效性和安全性通过 romiplostim 起始时的免疫血小板减少症 (ITP) 阶段（新诊断/持续/慢性）进行评估。这是对一项前瞻性、德国、多中心、观察性研究的事后分析，研究对象是接受 ≥1 剂量罗米司亭的 ITP 成人。收集≤2年的随访数据。结果包括总体血小板反应（开始罗米司亭后 2-24 周≥1 血小板计数≥50 × 109/L）或持久血小板反应（14-24 周≥75% 的测量结果≥50 × 109/L）以及通过 ITP 阶段评估的药物不良反应 (ADR)。分析了 96 名患者的数据（新诊断，n = 18；持续性，n = 25；慢性，n = 53）。在2至24周的随访期间，新诊断、持续性或慢性ITP患者的总体血小板反应率分别为100%（95%置信区间：81.5-100）、100%（86.3-100）和96.2%（87.0-99.5），并且血小板反应在88.2%（63.6-98.5）中是持久的。 65.0% (40.8–84.6) 和 69.4% (54.6–81.7) 的患者。在 2 年随访期间，各阶段的 ADR 发生率为 24.0-35.8%。两名慢性 ITP 患者出现骨髓不良反应；未发生血栓性 ADR。在常规临床实践中，罗米司亭对新诊断、持续或慢性 ITP 患者有效且耐受性良好。
The effectiveness and safety of romiplostim were evaluated by immune thrombocytopenia (ITP) phase (newly diagnosed/persistent/chronic) at romiplostim initiation. This is a post hoc analysis of a prospective, German, multicentre, observational study in adults with ITP who received ≥1 dose of romiplostim. Follow-up data were collected for ≤2 years. Outcomes included overall platelet response (≥1 platelet count ≥50 × 109/L at 2–24 weeks after romiplostim initiation) or durable platelet response (≥75% of measurements ≥50 × 109/L at 14–24 weeks) and adverse drug reactions (ADRs), evaluated by ITP phase. Data from 96 patients were analysed (newly diagnosed, n = 18; persistent, n = 25; chronic, n = 53). During the 2- to 24-week follow-up, overall platelet response was achieved in 100% (95% confidence interval: 81.5–100), 100% (86.3–100), and 96.2% (87.0–99.5) of patients with newly diagnosed, persistent, or chronic ITP, respectively, and platelet responses were durable in 88.2% (63.6–98.5), 65.0% (40.8–84.6), and 69.4% (54.6–81.7) of patients. During the 2-year follow-up, ADRs occurred in 24.0–35.8% of patients across phases. Two patients with chronic ITP experienced bone marrow ADRs; no thrombotic ADRs occurred. Romiplostim was effective and well tolerated in patients with newly diagnosed, persistent, or chronic ITP in routine clinical practice.
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影响因子：
3.8
作者：
Provan D;Newland AC
通讯作者：
Newland AC
影响因子：
6.5
作者：
Kuter, David J.;Newland, Adrian;Eisen, Melissa
通讯作者：
Eisen, Melissa
影响因子：
2.9
作者：
Heddle, NM;Cook, RJ;Rebulla, P
通讯作者：
Rebulla, P
影响因子：
3.8
作者：
Snell Taylor SJ;Nielson CM;Breskin A;Saul B;Yu Y;Alam N;Eisen M;Hippenmeyer J;Janssens A;Kozak T;Papadaki HA;Selleslag D;Viallard JF;Feistritzer C;Kaiafa G;Kelsh M;Kilpatrick K;Brookhart MA;McGrath LJ
通讯作者：
McGrath LJ
影响因子：
2.1
作者：
Contis, Anne;Lazaro, Estibaliz;Viallard, Jean-Francois
通讯作者：
Viallard, Jean-Francois