Efficacy, safety, and pharmacokinetics of natalizumab in Japanese multiple sclerosis patients: A double-blind, randomized controlled trial and open-label pharmacokinetic study

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• 作者：Takahiko Saida^a ; ^{saida_takahiko@maia.eonet.ne.jp} ; Jun-ichi Kira^b ; Shuji Kishida^c ; Takashi Yamamura^d ; Yukiko Sudo^e ; Kazutaka Ogiwara^e ; JT Tibung^e ; Nisha Lucas^f ; Meena Subramanyam^f ; On behalf of Natalizumab Trial Principal Investigators
• 关键词：AE ; adverse event ; ARR ; annualized relapse rate ; AUC ; area under the concentration time curve ; AUC0&ndash ; last ; area under the curve to the last measurable concentration of a dosing interval ; AUC0&ndash ; &infin ; area under the curve to infinity ; AUC0&ndash ; 672 ; area under the curve for dosing interval ; CI ; confidence interval ; CL ; systemic clearance ; Cmax ; maximum concentration ; Ctrough ; trough concentration ; EDSS ; Expanded Disability Status Scale ; ELISA ; enzyme-linked immunosorbent assay ; Gd ; g
• 刊名：Multiple Sclerosis and Related Disorders
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：11
• 期：Complete
• 页码：25-31
• 全文大小：403 K
• 卷排序：11

文摘

Natalizumab is an antibody treatment for relapsing-remitting multiple sclerosis. This study investigated natalizumab efficacy and safety in Japanese patients. New brain lesion development rate was lower with natalizumab than placebo (p<0.001). Annualized relapse rate was 0.53 for natalizumab and 1.73 for placebo (p<0.001). Natalizumab had a favorable safety and tolerability profile in Japanese patients.