Pegylation and interferons in multiple sclerosis

IF 0.4 Q4 HEALTH CARE SCIENCES & SERVICES
D. Centonze, E. Puma, C. Saleri, G. Vestri, S. Iannazzo, L. Santoni, L. Giuliani, P. Canonico
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引用次数: 1

Abstract

Pegylation is a procedure used for drug development since the 1970s and consists of the conjugation of a polyethylene glycol molecule (PEG) to a drug. PEG has shown to be safe and effective in improving the pharmacokinetic and pharmacodynamic profile of drugs. Recently, a 20 kDa linear chain of PEG was conjugated to interferon beta-1a with the aim to offer a new treatment option to relapsing-remitting multiple sclerosis (RRMS) patients. Due to a prolonged bioavailability, this new drug can be administered less frequently (every two weeks) than the other interferons beta available, thus allowing to hypothesize a better adherence to the treatment, which, in turn, should result in better clinical and economic outcomes. A phase III clinical trial has proven its effectiveness compared to placebo in RRMS patients, as well as a safety profile comparable to that found in other interferon beta preparations. The immunogenicity of this new molecule is < 1%, thus minimizing the suppression or reduction of interferon beta biological activity that could come from the development of Neutralizing Antibodies (NAbs). [Article in Italian]
聚乙二醇化与干扰素在多发性硬化症中的作用
聚乙二醇化是自20世纪70年代以来用于药物开发的一种程序,由聚乙二醇分子(PEG)与药物的偶联组成。聚乙二醇已被证明在改善药物的药代动力学和药效学方面是安全有效的。最近,一个20 kDa的PEG线性链被偶联到干扰素β -1a上,目的是为复发缓解型多发性硬化症(RRMS)患者提供一种新的治疗选择。由于生物利用度较长,这种新药的使用频率(每两周一次)比其他可用的干扰素β要低,因此可以假设更好地坚持治疗,这反过来应该会产生更好的临床和经济结果。一项III期临床试验已经证明,与安慰剂相比,它在RRMS患者中的有效性,以及与其他干扰素制剂相当的安全性。这种新分子的免疫原性小于1%,从而最大限度地减少了干扰素β生物活性的抑制或降低,这种抑制或降低可能来自中和抗体(nab)的发展。[意大利语文章]
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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