Department of Neurology, Kyoto Min-iren Chuo Hospital, Kyoto, Japan.
Mult Scler. 2012 Dec;18(12):1782-90. doi: 10.1177/1352458512442261. Epub 2012 Apr 4.
Interferon 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).
Patients 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.
IM 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.
This 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.
干扰素β（IFNβ）是多发性硬化症（MS）的标准治疗方法。在 25 例复发缓解型多发性硬化症（RRMS）患者中评估了肌肉内（IM）IFNβ-1a（AVONEX®）的疗效。
本研究纳入了此前未接受 IFNβ或其他疾病修正治疗的 RRMS 患者。主要终点是在接受 IM IFNβ-1a 30μg每周一次治疗的 24 周中的最后 12 周内和治疗前 12 周内，4 次脑部 MRI 扫描中检测到的强化病变的平均总数。病变由盲法研究者计数。
与治疗前相比，IM IFNβ-1a 显著降低了强化病变的中位数数量，从 2.5 降至 0.3（p<0.0001）。新强化病变的中位数数量也从 2.0 显著降至 0.3（p=0.0002）。血清中新蝶呤的诱导方式与之前在白种人 RRMS 人群中观察到的方式相似。研究期间未发生新的不良反应事件。
这是首例在日本 RRMS 患者中进行的 IM IFNβ-1a 研究，基于对治疗前和治疗后强化病变的评估，其疗效与白种人患者报告的结果相似。
