Fontolizumab,人源化抗干扰素γ抗体治疗中重度克罗恩病的临床研究:一项关于剂量升级、安慰剂对照、双盲、药物单剂量应用和多剂量应用的安全性与耐受性的研究

作     者：Reinisch W. Hommes D.W. Van Assche G. 王铮 

作者机构：Universitaetsklinik Innere Medizin IVAbteilung Gastroenterologie and HepatologieWaehringer Guertel 18-20A-1090 ViennaAustria Prof. 

出 版 物：《世界核心医学期刊文摘（胃肠病学分册）》 (Core Journals in Gastroenterology)

年 卷 期：2006年第2卷第12期

页      面：42-43页

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

主　　题：克罗恩病 Fontolizumab 剂量应用 干扰素γ 人源化 安慰剂对照 药效动力学 免疫源性 免 

摘      要：Introduction:This study was designed to evaluate the safety of fontolizumab,a humanised anti-interferon γ antibody,in patients with moderate to severe Crohn’s disease(CD) .Patients and methods:Forty five patients with a CD activity index(CDAI) of 250-450 were randomised in a double blind,placebo controlled,dose escalating fashion to receive single doses of fontolizumab(0.1,1.0,and 4.0 mg/kg) or *** day 29,patients with clinical response were re-randomised to receive three additional doses of one half their initial fontolizumab dose or placebo at four weekly *** objectives were safety and *** outcomes included assessments of immunogenicity,clinical activity,and potential pharmacodynamic ***:Treatment was generally well *** were slightly more reports of chills,flu-like syndrome,asthenia,nausea,and vomiting in the 1.0 mg and 4.0 mg/kg fontolizumab *** serious adverse events rated as worsening of CD occurred under *** to fontolizumab were confirmed in one *** differences in clinical activity parameters were noted between any of the active treatment groups and placebo,with the placebo group having a particularly favourable outcome(60% response and 40% remission) .By day 29,a more enhanced decrease in median Crohn’s disease endoscopic index of severity(p = 0.02) and serum C reactive protein(p 0.001) was observed in the 4.0 mg/kg(n = 14) fontolizumab cohort compared with placebo(n = 10) .Pharmacodynamic effects were observed by ***:Fontolizumab was well tolerated with minimal immunogenicity at doses of up to 4.0 mg/kg in patients with CD.A biological activity of fontolizumab is suggested.