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首页> 外文期刊>Journal of interferon and cytokine research: The official journal of the International Society for Interferon and Cytokine Research >PEGylated interferon beta-1a: meeting an unmet medical need in the treatment of relapsing multiple sclerosis.
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PEGylated interferon beta-1a: meeting an unmet medical need in the treatment of relapsing multiple sclerosis.

机译:聚乙二醇化干扰素β-1a:在复发性多发性硬化症的治疗中满足未满足的医学需求。

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摘要

Multiple sclerosis is a chronic autoimmune disease of the central nervous system for which a number of disease-modifying therapies are available, including interferon beta (Avonex(R), Rebif(R), and Betaseron/Betaferon(R)), glatiramer acetate (Copaxone(R)), and an anti-VLA4 monoclonal antibody (Tysabri(R)). Despite the availability and efficacy of these protein and peptide drugs, there remains a significant number of patients who are untreated, including those with relatively mild disease who choose not to initiate therapy, those wary of injections or potential adverse events associated with therapy, and those who have stopped therapy due to perceived lack of efficacy. Since these drugs have side effects that may affect a patient's decision to initiate and to remain on treatment, there is a need to provide a therapy that is safe and efficacious but that requires a reduced dosing frequency and hence a concomitant reduction in the frequency of side effects. Here we describe the development of a PEGylated form of interferon beta-1a that is currently being tested in a multicenter, randomized, double-blind, parallel-group, placebo-controlled study in relapsing multiple sclerosis patients, with the aim of determining the safety and efficacy of 125 microg administered via the subcutaneous route every 2 or 4 weeks.
机译:多发性硬化症是中枢神经系统的一种慢性自身免疫性疾病,可采用多种疾病改良疗法,包括干扰素β(Avonex®,Rebif®和Betaseron /Betaferon®),醋酸格拉替雷( )和抗VLA4单克隆抗体(Tysabri)。尽管这些蛋白质和肽类药物具有实用性和有效性,但仍有大量未接受治疗的患者,包括那些患有较轻疾病的患者,他们选择不开始治疗,对注射持谨慎态度或与治疗相关的潜在不良事件,以及那些因感觉缺乏疗效而停止治疗的人。由于这些药物的副作用可能会影响患者开始和继续治疗的决定,因此需要提供一种安全有效的疗法,但需要减少用药频率,因此需要减少用药频率效果。在这里,我们描述了PEG化形式的干扰素β-1a的开发,目前正在多发性硬化症患者的多中心,随机,双盲,平行组,安慰剂对照研究中进行测试,旨在确定安全性每2或4周通过皮下途径给药125微克的功效。

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