title: Natalizumab for Achieving Relapse-Free, T1 Gadolinium-Enhancing-Lesion-Free, and T2 Lesion-Free Status in Japanese Multiple Sclerosis Patients: A Phase 2 Trial Subanalysis.
abstract: BACKGROUND
  In a phase 2 trial of natalizumab in Japanese patients with relapsing-remitting multiple sclerosis (RRMS), treatment-related changes in relapses, brain lesions, and disability worsening were found to be comparable with those observed in the phase 3 studies of natalizumab in primarily non-Asian RRMS patients.
  
  
  METHODS
  This subanalysis of the placebo-controlled phase 2 trial of natalizumab in Japanese RRMS patients (n = 94) evaluated the effects of natalizumab versus placebo on the proportion of patients who achieved relapse-free, T1 gadolinium-enhancing (Gd+) lesion-free, and new/newly enlarged T2 lesion-free status, defined as "no evidence of inflammatory disease activity" (NEDA)-like status, after 24 weeks of treatment.
  
  
  RESULTS
  In this subanalysis, significantly more natalizumab-treated than placebo-treated patients achieved NEDA-like status (76.6% vs. 31.9%; P < 0.0001). In addition, the odds ratio (95% confidence interval) for patients on natalizumab to reach NEDA-like status was 6.98 (2.80-17.38) compared with placebo patients.
  
  
  CONCLUSIONS
  These results confirm previous findings indicating that natalizumab is efficacious in Japanese patients with RRMS.
  
  
  BACKGROUND
  Biogen.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier, NCT01440101.
authors.affiliation: Kansai Multiple Sclerosis Center and Kyoto Min-iren Central Hospital, Kyoto, Japan. saida_takahiko@maia.eonet.ne.jp.
authors.forename: Takahiko
authors.initials: T
authors.lastname: Saida
authors.affiliation: Department of Neurology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Jun-Ichi
authors.initials: JI
authors.lastname: Kira
authors.affiliation: Hakusuikai Hatsuishi Hospital, Chiba, Japan.
authors.forename: Shuji
authors.initials: S
authors.lastname: Kishida
authors.affiliation: National Center of Neurology and Psychiatry, Kodaira, Tokyo, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Yamamura
authors.affiliation: Biogen Japan Ltd, Tokyo, Japan.
authors.forename: Nobuhisa
authors.initials: N
authors.lastname: Ohtsuka
authors.affiliation: Biogen, Cambridge, MA, USA.
authors.forename: Qunming
authors.initials: Q
authors.lastname: Dong
authors.affiliation: Biogen Japan Ltd, Tokyo, Japan.
authors.forename: J T
authors.initials: JT
authors.lastname: Tibung
keywords: Gadolinium-enhancing lesions; Japanese patients; Natalizumab; Relapsing-remitting multiple sclerosis; T2 lesions