TY - JOUR
T1 - Natalizumab for Achieving Relapse-Free, T1 Gadolinium-Enhancing-Lesion-Free, and T2 Lesion-Free Status in Japanese Multiple Sclerosis Patients
T2 - A Phase 2 Trial Subanalysis
AU - Saida, Takahiko
AU - Kira, Jun Ichi
AU - Kishida, Shuji
AU - Yamamura, Takashi
AU - Ohtsuka, Nobuhisa
AU - Dong, Qunming
AU - Tibung, J. T.
N1 - Funding Information:
Biogen provided funding for this study, for the publication of this article, and for editorial support in the development of this manuscript; Linda A. Goldstein, PhD, and Alexandra W. Davis (Ashfield Healthcare Communications, Middletown, CT, USA) provided writing support based on input from authors, and Joshua Safran (Ashfield Healthcare Communications) copyedited and styled the manuscript per journal requirements. This study was supported by Biogen (Cambridge, MA, USA), which provided funding for editorial support in the development of this paper and reviewed and provided feedback on the paper to the authors. The authors had full editorial control of the paper and provided their final approval of all content. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data, the accuracy of the data analysis, and the work as a whole. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. Portions of this manuscript were submitted as an abstract to the 25th Annual Meeting of the Japanese Society for Neuroimmunology; this abstract was accepted for publication and was presented as a poster on September 29?30, 2016, in Nagasaki, Japan.
PY - 2017/6/1
Y1 - 2017/6/1
N2 - 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.
AB - 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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U2 - 10.1007/s40120-016-0062-4
DO - 10.1007/s40120-016-0062-4
M3 - Article
AN - SCOPUS:85020012520
VL - 6
SP - 153
EP - 159
JO - Neurology and Therapy
JF - Neurology and Therapy
SN - 2193-8253
IS - 1
ER -