Key result
Natalizumab significantly increased the proportion of Japanese patients with relapsing-remitting multiple sclerosis achieving NEDA-like status at 24 weeks compared to placebo (76.6% vs. 31.9%; OR 6.98).
Why the study?
Does natalizumab improve NEDA-like status in Japanese patients with RRMS?
RCT (n=94)
Double-blind
Randomized
Yes
Does natalizumab improve NEDA-like status in Japanese patients with RRMS?
Natalizumab significantly increases the proportion of Japanese RRMS patients achieving NEDA-like status compared to placebo over 24 weeks.
Supports natalizumab for NEDA-like status in Japanese RRMS; extends prior RCT evidence to this population.
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.
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Saida et al. (2017) conducted an RCT in Relapsing-remitting multiple sclerosis (RRMS) (n=94). Natalizumab vs. Placebo was evaluated on Proportion of patients achieving relapse-free, T1 gadolinium-enhancing lesion-free, and new/newly enlarged T2 lesion-free status (NEDA-like status) at week 24 (OR 6.98, 95% CI 2.80-17.38, p=<0.0001). Natalizumab significantly increased the proportion of Japanese patients with relapsing-remitting multiple sclerosis achieving NEDA-like status at 24 weeks compared to placebo (76.6% vs. 31.9%; OR 6.98).
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