Abstract:
BACKGROUND:Immune thrombocytopenic purpura (ITP) is characterized by platelet deficiency due to platelet destruction and/or inadequate production. Initial therapy consists of corticosteroids or intravenous immunoglobulin (IVIg). Patients with chronic refractory disease might undergo splenectomy. Although there is no treatment of choice in those who do not respond to splenectomy, immunosuppressive agents are typically prescribed. Romiplostim is the first available drug in a recently developed class of agents that work through stimulation of the thrombopoietin (TPO) receptor (c-Mpl) to increase platelet production. OBJECTIVE:The aim of this report was to review the mechanism of action, pharmacology, clinical activity, and adverse events associated with the use of romiplostim for the treatment of thrombocytopenia in patients with chronic ITP. METHODS:MEDLINE, Google Scholar, International Pharmaceutical Abstracts, and Web of Science were searched for English-only clinical trials and reviews (publication dates: 2000-June 1, 2009; key terms: romiplostim, Nplate, ITP, and idiopathic and immune thrombocytopenic purpura). Abstracts from the 2000-2008 meetings of the American Society of Hematology and references from relevant articles were reviewed. RESULTS:A total of 6 studies were included. Romiplostim is the first marketed agent developed to directly stimulate the bone marrow to produce platelets. Produced in Escherichia coli using recombinant DNA technology, it is an Fc-peptide fusion protein. It works intracellularly in a manner similar to that of the naturally occurring TPO to activate the transcriptional pathways, leading to increased platelet production via stimulation of the c-Mpl receptor. Romiplostim was approved by the US Food and Drug Administration for the treatment of chronic ITP primarily based on the findings from 2 multicenter, randomized, placebo-controlled, parallel-group studies in 125 adult patients with chronic ITP and an insufficient response to corticosteroids, IVIg, and/or splenectomy. The most common prior treatments were corticosteroids (94%) and IVIg (80%). Sixty-three patients (50%) were splenectomized a median of 6.6 years earlier. Baseline platelet counts were <30 x 10(9) cells/L. The initial dose of romiplostim was 1 microg/kg/wk SC, with adjustments to maintain platelet counts between 50 and 200 x 10(9) cells/L. The primary end point was a durable platelet response (>or=50 x 10(9) cells/L for >or=6 of the last 8 weeks of treatment). The proportion of patients in whom a durable platelet response was achieved was significantly greater with romiplostim than with placebo (49% vs 2%, respectively; P < 0.001). Overall platelet responses (durable plus transient) were achieved in 83% (69/83) with romiplostim and 7% (3/42) with placebo (P < 0.001). An interim report of findings from an ongoing extension study found that response was maintained for up to 156 weeks (median, 69 weeks) with romiplostim. The most common adverse events were headache (37%), nasopharyngitis (32%), contusion (30%), epistaxis (30%), fatigue (30%), arthralgia (25%), and diarrhea (25%). CONCLUSIONS:Based on the findings from this review, romiplostim administration has been associated with a durable platelet response in these patients with refractory chronic ITP. Romiplostim has been found to be generally well tolerated.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Cersosimo RJdoi
10.1016/j.clinthera.2009.09.013subject
Has Abstractpub_date
2009-09-01 00:00:00pages
1887-907issue
9eissn
0149-2918issn
1879-114Xpii
S0149-2918(09)00342-7journal_volume
31pub_type
杂志文章,评审abstract:BACKGROUND:Changing etiologic patterns and the growing problem of antimicrobial resistance, particularly an increase in macrolide-resistant pneumococcal bacteremia, are causing physicians to adopt new approaches to the treatment of community-acquired pneumonia (CAP). OBJECTIVE:The relative efficacy and tolerability of...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0149-2918(02)80034-0
更新日期:2002-08-01 00:00:00
abstract::This study evaluated the efficacy, safety, and most suitable dose of omeprazole in short-term acute treatment (4 weeks) and maintenance treatment (6 months) of patients older than 60 years of age with endoscopically diagnosed gastric ulcer (GU) or duodenal ulcer (DU). This randomized, prospective study included 156 pa...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1994-11-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究
doi:
更新日期:1993-09-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1982-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 信件,多中心研究
doi:10.1016/j.clinthera.2020.02.022
更新日期:2020-05-01 00:00:00
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pub_type: 杂志文章
doi:10.1016/s0149-2918(00)83032-5
更新日期:2000-11-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/S0149-2918(10)80027-X
更新日期:2010-12-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2019.10.005
更新日期:2019-12-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(98)80040-4
更新日期:1998-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1985-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析
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更新日期:2018-04-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2011.06.004
更新日期:2011-07-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(08)80045-8
更新日期:2008-07-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2008.11.018
更新日期:2008-11-01 00:00:00
abstract::The efficacy and safety of transferring 76 patients with poorly controlled type II diabetes mellitus from various self-mixed human insulin regimens to a premixed insulin regimen (Novolin 70/30, 70% NPH and 30% Regular insulin, semisynthetic) were evaluated in a 24-week, multicenter, open-label study. During the initia...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究
doi:
更新日期:1994-01-01 00:00:00
abstract:BACKGROUND:Idiopathic thrombocytopenic purpura (ITP) is a relatively rare acquired autoimmune disease characterized by either decreased platelet production or increased platelet destruction leading to reduced platelet counts and increased risk of bleeding. Immune modulators have been used in treatment; however, a novel...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2011.10.004
更新日期:2011-11-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2002-04-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析,评审
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更新日期:2005-06-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2012.05.006
更新日期:2012-07-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2013.06.019
更新日期:2013-08-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1985-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
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更新日期:2002-11-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
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更新日期:2018-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2014.10.013
更新日期:2014-11-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1990-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0149-2918(04)90055-0
更新日期:2004-04-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2013.02.024
更新日期:2013-04-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2018.03.009
更新日期:2018-06-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究
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更新日期:2003-11-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(02)85013-5
更新日期:2002-01-01 00:00:00