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Nature:应用单克隆抗体治疗牛皮癣

新药编辑:新特药 更新时间:2015-04-19

2015年3月19日讯 /tumor.net.cn/ --近日,来自奥地利的科学家们在著名国际期刊nature在线发表了他们的最新研究成果,他们发现了一种名叫Tildrakizumab的单克隆抗体能够有效治疗银屑病,并通过一系列临床试验证明了其有效性,这为银屑病治疗提供了一种可靠有效的治疗方法。
 
银屑病是一种慢性炎症性皮肤病,影响着世界上约2%~3%的人口,对病人的生理和心理都带来了极为严重的不良影响。之前研究发现银屑病是一种免疫性疾病,针对其疾病特征开发了许多有效的靶向性治疗方法。最近一些研究将目光锁定在了IL12和IL23共有的IL-12/23p40亚基,特异性抑制IL-23或可改善银屑病病症。
 
在该项研究中,研究人员对一只名为Tildrakizumab的靶向IL-23p19亚基的单克隆抗体进行了评估,在该评估研究中,他们将中度至重度银屑病患者分为三部分,进行了随机性,安慰剂对照,连续性,多剂量等特点的I期研究,来为特异性靶向IL-23p19亚基的单克隆抗体改善银屑病疾病症状提供临床证据。结果表明,在进行了196天治疗后,第一部分和第三部分病人中,使用了3mg/kg 和10mg/kg药物剂量组的所有病人的银屑病区域和严重程度指数评分(PASI)均下降了75%,而在第二部分病人中,在进行了112天治疗后,3mg/kg药物剂量组有三分之二的病人达到了PASI75,而在10mg/kg药物剂量组仅有1人未达到这一标准。
 
Tildrakizumab抗体的出现表明了人们在中度至重度银屑病临床治疗方面取得了巨大进展。(tumor.net.cn)

 
Clinical improvement in psoriasis with specific targeting of interleukin-23
 
Tamara Kopp,Elisabeth Riedl,Christine Bangert,Edward P. Bowman,Elli Greisenegger,Ann Horowitz,Harald Kittler,Wendy M. Blumenschein,Terrill K.McClanahan,Thomas Marbury,Claus Zachariae,Danlin Xu,Xiaoli Shirley Hou,Anish Mehta,Anthe S. Zandvliet,Diana Montgomery,Frank van Aarle& Sauzanne Khalilieh
 
Psoriasis is a chronic inflammatory skin disorder that affects approximately 2-3% of the population worldwide and has severe effects on patients' physical and psychological well-being1, 2, 3. The discovery that psoriasis is an immune-mediated disease has led to more targeted, effective therapies; recent advances have focused on the interleukin (IL)-12/23p40 subunit shared by IL-12 and IL-23. Evidence suggests that specific inhibition of IL-23 would result in improvement in psoriasis. Here we evaluate tildrakizumab, a monoclonal antibody that targets the IL-23p19 subunit, in a three-part, randomized, placebo-controlled, sequential, rising multiple-dose phase I study in patients with moderate-to-severe psoriasis to provide clinical proof that specific targeting of IL-23p19 results in symptomatic improvement of disease severity in human subjects. A 75% reduction in the psoriasis area and severity index (PASI) score (PASI75) was achieved by all subjects in parts 1 and 3 (pooled) in the 3 and 10 mg kg?1 groups by day 196. In part 2, 10 out of 15 subjects in the 3 mg kg?1 group and 13 out of 14 subjects in the 10 mg kg?1 group achieved a PASI75 by day 112. Tildrakizumab demonstrated important clinical improvement in moderate-to-severe psoriasis patients as demonstrated by improvements in PASI scores and histological samples.

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