Title |
Safety and Efficacy of Natalizumab in Japanese Patients with Relapsing-Remitting Multiple Sclerosis: Open-Label Extension Study of a Phase 2 Trial
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Published in |
Neurology and Therapy, December 2016
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DOI | 10.1007/s40120-016-0059-z |
Pubmed ID | |
Authors |
Takahiko Saida, Jun-Ichi Kira, Shuji Kishida, Takashi Yamamura, Nobuhisa Ohtsuka, Yan Ling, Shinichi Torii, Nisha Lucas, Geoffrey Kuesters, Deb Steiner, J. T. Tibung, on behalf of the Natalizumab Trial Principal Investigators |
Abstract |
The efficacy of natalizumab was evaluated in Japanese patients with relapsing-remitting multiple sclerosis (RRMS) in a 24-week, phase 2 bridging study. An open-label, 2-year extension study from this trial was conducted to assess the safety and efficacy of natalizumab treatment in Japanese patients. A total of 97 patients (43 previously on placebo; 54 previously on natalizumab) who had completed the bridging study were treated with 300 mg natalizumab every 4 weeks. Multiple sclerosis relapses, changes in Expanded Disability Status Scale (EDSS) scores, and adverse events were assessed at regular intervals. Anti-natalizumab and anti-JC virus (JCV) antibodies were measured. After 2 years of natalizumab treatment, the mean adjusted annualized relapse rate was 0.30 (95% confidence interval [CI]: 0.18-0.52) among previously-on-placebo patients and 0.13 (95% CI: 0.05-0.29) among previously-on-natalizumab patients. The mean change in EDSS score from baseline to week 120 was -0.03 among previously-on-placebo patients and -0.18 among previously-on-natalizumab patients. In both groups, >90% of patients experienced ≥1 adverse event. Two previously-on-placebo patients developed persistently positive anti-natalizumab antibodies. Approximately 65% of all patients tested positive for anti-JCV antibodies at open-label treatment initiation. No deaths or progressive multifocal leukoencephalopathy cases were reported. The efficacy and safety findings from this 2-year open-label extension study are comparable to and confirm the results of other clinical trials of natalizumab conducted in non-Asian patient populations, and provide longer-term evidence of efficacy and safety in Japanese patients. ClinicalTrials.gov identifier NCT01416155. Biogen. |
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Unknown | 1 | 100% |
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Members of the public | 1 | 100% |
Mendeley readers
Geographical breakdown
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Unknown | 43 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Other | 6 | 14% |
Student > Master | 6 | 14% |
Student > Bachelor | 5 | 12% |
Researcher | 4 | 9% |
Student > Doctoral Student | 2 | 5% |
Other | 8 | 19% |
Unknown | 12 | 28% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 16 | 37% |
Neuroscience | 4 | 9% |
Nursing and Health Professions | 2 | 5% |
Biochemistry, Genetics and Molecular Biology | 1 | 2% |
Immunology and Microbiology | 1 | 2% |
Other | 5 | 12% |
Unknown | 14 | 33% |