Related Experiment Video
Updated: Mar 8, 2026
Magnetic Resonance Imaging of Multiple Sclerosis at 7.0 Tesla
Published on: February 19, 2021
Natalizumab for Achieving Relapse-Free, T1 Gadolinium-Enhancing-Lesion-Free, and T2 Lesion-Free Status in Japanese
Takahiko Saida1, Jun-Ichi Kira2, Shuji Kishida3
1Kansai Multiple Sclerosis Center and Kyoto Min-iren Central Hospital, Kyoto, Japan. saida_takahiko@maia.eonet.ne.jp.
Introduction:
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.
Conclusion:
These results confirm previous findings indicating that natalizumab is efficacious in Japanese patients with RRMS.
Funding:
Biogen.
Trial Registration:
ClinicalTrials.gov identifier, NCT01440101.
