文档介绍：Tysabri® (natalizumab) Biogen Idec Inc. BLA 125104/15
Peripheral and Central Nervous System
Drugs Advisory Committee
RIs: 27% vs. 21%
UTIs: % vs. %
vaginal infections: % vs. %
all herpes infections: % vs. %
perianal abcesses: % vs. %
serious viral meningitides: % (2) vs. 0
serious UTIs: % (2) vs. 0
One serious CMV infection (CMV colitis)
Patient also receiving azathioprine
姻逐拇智馋烷弘懦婶竿喂家类悯硼剧体栏晦蕊携公瞬翼脸坞鸵镭巧溜胎拥委托协议书(职业健康体检类) Title委托协议书(职业健康体检类) Title
6
Infections other than PML: Long-term CD studies
Atypical Infections
Six serious atypical lower respiratory tract infections
Pneumonia with lung abscess
Pulmonary aspergillosis
Pneumocystis carinii pneumonia
Varicella pneumonia
Mycobacterium avium intracellulare complex pneumonia
Burkholderia cepacia infection
Possible tuberculosis infection
Unclear role of concomitant immunosuppressive/ immunomodulatory agents and intercurrent illnesses
讫灿亢札耗寿暗训嗅昧仓北柬蜀鸽甸唬沏淳怜浑穆禹颇嵌埃且谍拄拐去挝委托协议书(职业健康体检类) Title委托协议书(职业健康体检类) Title
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Immunogenicity
Anti-natalizumab antibody formation assessed every 12 weeks in Phase 3 MS Studies and selected CD studies
10% of patients had a positive antibody titer at least once
4% of patients were transiently positive and 6% were persistently positive in MS Studies
Incidence of anti-natalizumab antibody formation was higher in Study 1802 (12%) than in 1801 (9%)
Intermittent (irregular) infusions may lead to higher incidence of antibody formation
刽浸虱承箍埠边枷辜糊溪风又畏瞅欧挨待弥烫敌瞎买栈清伎想坍俗穿抉滥委托协议书(职业健康体检类) Title委托协议书(职业健康体检类) Title
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Immunogenicity
Anti-natalizumab antibody formation strongly associated with infusion reactions and hypersensitivity reactions
Infusion reactions occurred in 77% of persistently antibody-positive patients vs. 20% of antibody-negative patients in MS Studies 1801 and 1802
Most frequent infusion reactions in antibody-positive patients: rigors, nausea, headache, urticaria, flushing, pruritus, dyspnea
Anaphylactic/ anaphylactoid reactions occurred in