Humanized Anti-Tac in the treatment of uveitis

人源化 Anti-Tac 治疗葡萄膜炎

• 批准号: 6227959
• 负责人: ROBERT B. NUSSENBLATT
• 金额: --
• 依托单位: NATIONAL EYE INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6227959
• 关键词: antireceptor antibody; clinical research; cytokine receptors; eye disorder chemotherapy; human subject; human therapy evaluation; immunosuppressive; immunotherapy; interleukin 2; monoclonal antibody; uveitis

The goal of this study is to evaluate the safety and potential therapeutic activity of humanized anti-IL-2 receptor monoclonal antibody (Daclizumab) therapy in the treatment of patients with severe, sight-threatening, intermediate and posterior non-infectious uveitis.This is a non-randomized, open-label, pilot study. Patients with chronic, non-infectious bilateral, sight-threatening uveitis who were treated with a minimum of 20 mg of prednisone, cyclosporine, anti- metabolites, or any combination of these agents were eligible. Patients were weaned off these immunosuppressive agents according to a standardized schedule, while ultimately receiving Daclizumab infusions every 4 weeks.Anti-Interleukin 2 receptor antibody therapy, given intravenously with intervals of up to four weeks in lieu of standard immunosuppressive therapy, appeared to prevent the expression of severe sight-threatening intraocular inflammatory disease in nine of ten patients treated for a minimum of seven months, based on the primary end point of a loss of vision of 10 letters or more from baseline in either eye. All patients were able to tolerate the study medications without the need for dose reduction. - uveitis, Interleukin-2, anti-Tac antibody, immunosuppression, - Human Subjects

本研究的目的是评估人源化抗il -2受体单克隆抗体（Daclizumab）治疗严重、视力威胁、中期和后部非感染性葡萄膜炎患者的安全性和潜在治疗活性。这是一项非随机、开放标签的试点研究。慢性、非感染性双侧、威胁视力的葡萄膜炎患者接受至少20mg强的松、环孢素、抗代谢物或这些药物的任何组合治疗是合格的。患者根据标准化的时间表停用这些免疫抑制剂，同时最终每4周接受一次Daclizumab输注。静脉注射抗白细胞介素2受体抗体治疗，间隔4周，代替标准免疫抑制治疗，在治疗至少7个月的10名患者中，有9名患者的主要终点是任何一只眼睛的视力从基线下降10个字母或更多，似乎可以预防严重威胁视力的眼内炎症性疾病的表达。所有患者都能够耐受研究药物而无需减少剂量。-葡萄膜炎，白细胞介素-2，抗tac抗体，免疫抑制，-人类受试者