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    • 4. 发明申请
    • METHODS OF TREATING INFLAMMATORY AND AUTOIMMUNE DISEASES WITH NATALIZUMAB
    • 用NATALIZUMAB治疗炎症和自身免疫疾病的方法
    • WO2007103112A3
    • 2007-11-29
    • PCT/US2007005265
    • 2007-03-02
    • ELAN PHARM INCYEDNOCK THEODORE A
    • YEDNOCK THEODORE A
    • A61K39/395
    • G01N33/6854A61K39/39541A61K2039/505A61K2039/545C07K16/2839C07K16/2842A61K2300/00
    • Natalizumab is a safe and efficacious treatment for inflammatory and autoimmune diseases, such as multiple sclerosis, Crohn's Disease, and rheumatoid arthritis. Chain swapping between natalizumab and IgG4 molecules acts to reduce the level of bivalent natalizumab present following administration of natalizumab, and thus to lower the activity of natalizumab in the patient. Differences in IgG4 levels across patients or within a single patient across time may change the pharmacokinetic profile of natalizumab. Patients with lower levels of IgG4 may experience higher nadir levels of natalizumab during a dosing period. Monitoring IgG4 and/or bivalent natalizumab levels, and determining a dose or dosage period based on the monitoring may improve the safety and/or efficacy of natalizumab therapy.
    • 纳他珠单抗对于炎性和自身免疫疾病如多发性硬化,克罗恩病和类风湿性关节炎是一种安全有效的治疗方法。 那他珠单抗和IgG4分子之间的链交换用于降低给予natalizumab后存在的二价natalizumab的水平,从而降低该natalizumab在患者体内的活性。 跨越患者或跨越单个患者的IgG4水平的差异可能改变那他珠单抗的药代动力学特征。 在给药期间,具有较低水平的IgG4的患者可能经历更高的天竺葵素水平。 监测IgG4和/或二价那他珠单抗水平,并且基于监测确定剂量或剂量周期可以提高那他珠单抗治疗的安全性和/或疗效。