Method of treating idiopathic thrombocytopenia purpura (ITP) with romiplostim

A technology of romiprostim and platelets, which is applied in the field of treating idiopathic thrombocytopenic purpura (ITP) with romiprostim, and can solve the problems of compliance, large cost and the like

Pending Publication Date: 2020-08-21
AMGEN INC
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  • Abstract
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  • Claims
  • Application Information

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Problems solved by technology

However, long-term treatment can lead to compliance issues and substantial costs (Ghanima et al., 2012)

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  • Method of treating idiopathic thrombocytopenia purpura (ITP) with romiplostim
  • Method of treating idiopathic thrombocytopenia purpura (ITP) with romiplostim
  • Method of treating idiopathic thrombocytopenia purpura (ITP) with romiplostim

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Embodiment Construction

[0023] TPO receptor agonists are not an ideal treatment option for ITP because not every patient responds, and those who do respond are not always able to maintain their response. The present invention is based on the largest study to date conducted in children using TPO receptor agonists, with over 182 patient-years of exposure, or 2.8 years of exposure per patient for 65 patients. Importantly, approximately 1 / 4 of patients were able to discontinue ITP therapy and still maintain a hemostatic platelet count. The data described in this manuscript are extensive both in terms of number of patients (n=65) and duration of treatment (up to 7 years) and show that romigrastim has efficacy and demonstrates a safety profile similar to that seen in adults characteristic.

[0024] The aim of the study was to describe the safety and efficacy of long-term use of romigrastim in children with ITP, with the incidence of adverse events as the primary endpoint. Secondary endpoints included ass...

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Abstract

The present invention concerns a method of treating idiopathic thrombocytopenia purpura (ITP) in a patient having ITP, which comprises: (a) administering romiplostim weekly to the patient; (b) increasing the weekly dose until a platelet count of at least about 50 to 200 * 109 / L is reached; (c) decreasing the weekly dose of romiplostim if the platelet count remains >= 200 * 109 / L for two consecutive weeks; (d) discontinuing romiplostim if the platelet count has remained >= 200 * 109 / L for two consecutive weeks when the weekly dose is 1 ug / kg or the platelet count is >= 400 * 109 / L; and (e) if aplatelet count >= 200 * 109 / L is reached within the first 4 to 12 weeks of treatment, maintaining a treatment-free period of at least about 24 weeks during which the patient receives no romiplostim.

Description

Background technique [0001] Primary ITP is an autoimmune disorder characterized by suboptimal platelet production and accelerated platelet destruction mediated by both antibodies and T cells (Nugent et al., 2009). Adults with ITP typically have a chronic course, presenting an increased risk of bruising and skin bleeding, decreased quality of life, and rarely severe bleeding (Cines & McMillan, 2005). [0002] The main goal of treatment in these patients is to achieve durable improvements in platelet counts without ongoing therapy. Current treatment includes corticosteroids, anti-D immune globulin, and first-line therapy with intravenous immune globulin (IVIg), as well as romilastim, eltrombopag, rituximab, and splenectomy Second-line therapy. These first-line treatments produce a platelet response in most patients, but responses may only be observed over weeks to months (Provan et al., 2010). With second-line therapy such as rituximab, 15%-20% of patients can have a complete...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/19A61P7/04
CPCA61K38/196A61P7/04A61P7/00
Inventor M·塔伦蒂诺J·比塞尔M·艾森N·卡彭特X·王S·麦克
Owner AMGEN INC
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