Leussink V I, Warnke C, Tackenberg B, Wiendl H, Kieseier B C
Neurologische[Symbol: see text]Klinik,[Symbol: see text]Medizinische Fakultät, Universitätsklinikum Düsseldorf, Heinrich-Heine-Universität, Moorenstr. 5, 40225, Düsseldorf, Deutschland.
Nervenarzt. 2015 Apr;86(4):483-90. doi: 10.1007/s00115-015-4287-8.
Pegylation of pharmacological substances was developed in the 1970s as a way of improving their efficacy and elimination and hence reducing the dosage frequency. A prominent example is pegylation of IFNα, which revolutionized the treatment of virus hepatitis in the late 1990s. Efforts have now succeeded in producing a pegylated interferon beta (PEG-IFN-β1a) to treat multiple sclerosis (MS) and the efficacy and safety have been investigated in a phase III trial called the ADVANCE study. The 1-year results of this randomized, double blind, multicenter, placebo-controlled study in more than 1500 MS patients show that administration of subcutaneous PEG-IFN-β1a significantly reduces the annual relapse rate and disability progression. The safety and tolerability profile of PEG-IFN-β1a was found to be similar to that of conventional IFN-β drugs. The most common adverse events were flu-like symptoms and redness at the injection site. The results of this study underscore that PEG-IFN-β1a is an interesting new therapeutic option in the treatment of relapsing-remitting MS that combines highly effective interferon with the established tolerability and safety profile of IFN-β at a reduced dosage frequency.
药物的聚乙二醇化技术于20世纪70年代开发,旨在提高药物疗效、延长消除时间,从而减少给药频率。一个突出的例子是α干扰素的聚乙二醇化,它在20世纪90年代后期彻底改变了病毒性肝炎的治疗方法。目前,人们已成功研制出聚乙二醇化干扰素β(PEG-IFN-β1a)用于治疗多发性硬化症(MS),并在一项名为ADVANCE研究的III期试验中对其疗效和安全性进行了调查。这项针对1500多名MS患者的随机、双盲、多中心、安慰剂对照研究的1年结果表明,皮下注射PEG-IFN-β1a可显著降低年复发率和残疾进展。研究发现,PEG-IFN-β1a的安全性和耐受性与传统干扰素β药物相似。最常见的不良事件是流感样症状和注射部位发红。这项研究结果强调,PEG-IFN-β1a是复发缓解型MS治疗中一种有趣的新治疗选择,它将高效干扰素与干扰素β已确立的耐受性和安全性相结合,且给药频率降低。