• Mult. Scler. · Dec 2012

    Multicenter Study Clinical Trial

    Intramuscular interferon beta-1a is effective in Japanese patients with relapsing-remitting multiple sclerosis: a pre-treatment versus treatment comparison study of gadolinium-enhanced MRI brain lesions.

    • Takahiko Saida, Yasuto Itoyama, Kunio Tashiro, Kira Jun-Ichi J, Qi Hao, and Interferon Beta-1a Multiple Sclerosis Study Group of Japan.
    • Department of Neurology, Kyoto Min-iren Chuo Hospital, Kyoto, Japan. saida_takahiko@maia.eonet.ne.jp
    • Mult. Scler. 2012 Dec 1; 18 (12): 1782-90.

    Background And ObjectiveInterferon beta (IFNβ) is standard therapy for multiple sclerosis (MS). The efficacy of intramuscular (IM) IFNβ-1a (AVONEX(®)) was assessed in 25 Japanese patients with relapsing-remitting MS (RRMS).MethodsPatients with RRMS not previously treated with IFNβ or other disease-modifying therapies were included in this 36-week study. The primary outcome was the average total number of gadolinium-enhanced lesions detected on four brain MRI scans during the last 12 weeks of 24 weeks' treatment with IM IFNβ-1a 30 μg once weekly compared with the number during the 12-week pre-treatment period. Lesions were counted by blinded investigators.ResultsIM IFNβ-1a significantly decreased the median number of gadolinium-enhanced lesions from 2.5 to 0.3 (p < 0.0001) compared with pre-treatment values. The median number of new gadolinium-enhanced lesions also decreased significantly from 2.0 to 0.3 (p = 0.0002). Serum neopterin was induced in a manner similar to that observed previously in a Caucasian RRMS population. No new adverse events occurred during the study.ConclusionThis first study of IM IFNβ-1a in Japanese patients with RRMS demonstrated a level of efficacy similar to that reported in Caucasian patients based on an assessment of pre-treatment and post-treatment gadolinium-enhanced lesions.

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