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

Takahiko Saida,Jun-ichi Kira,Shuji Kishida,Takashi Yamamura, Yukiko Sudo, Kazutaka Ogiwara, J. T. Tibung,Nisha Lucas,Meena Subramanyam

Multiple Sclerosis and Related Disorders（2017）

引用 19|浏览9

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摘要

•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.

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AE,ARR,AUC,AUC0–last,AUC0–∞,AUC0–672,CI,CL,Cmax,Ctrough,EDSS,ELISA,Gd,IFNβ,IV,IVIG,JCV,N/A,NMO,NMOSD,PD,PK,PML,RRMS,SD,SE,T1/2,Tmax,VAS,Vd,VLA-4

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