Saida Takahiko, Kira Jun-Ichi, Kishida Shuji, Yamamura Takashi, Ohtsuka Nobuhisa, Dong Qunming, Tibung J T
Kansai Multiple Sclerosis Center and Kyoto Min-iren Central Hospital, Kyoto, Japan.
Department of Neurology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Neurol Ther. 2017 Jun;6(1):153-159. doi: 10.1007/s40120-016-0062-4. Epub 2017 Jan 11.
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.
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.
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.
These results confirm previous findings indicating that natalizumab is efficacious in Japanese patients with RRMS.
Biogen.
ClinicalTrials.gov identifier, NCT01440101.
在一项那他珠单抗用于日本复发缓解型多发性硬化症（RRMS）患者的2期试验中，发现与复发、脑损伤和残疾恶化相关的治疗变化与那他珠单抗在主要为非亚洲RRMS患者中的3期研究中观察到的变化相当。
这项对那他珠单抗用于日本RRMS患者（n = 94）的安慰剂对照2期试验的亚组分析，评估了那他珠单抗与安慰剂对治疗24周后达到无复发、无钆增强（Gd+）病灶以及无新的/新增大的T2病灶状态（定义为“无炎症疾病活动证据”[NEDA]样状态）的患者比例的影响。
在该亚组分析中，接受那他珠单抗治疗的患者达到NEDA样状态的比例显著高于接受安慰剂治疗的患者（76.6%对31.9%；P < 0.0001）。此外，与安慰剂组患者相比，接受那他珠单抗治疗的患者达到NEDA样状态的优势比（95%置信区间）为6.98（2.80 - 17.38）。
这些结果证实了先前的研究结果，表明那他珠单抗对日本RRMS患者有效。
百健公司。
ClinicalTrials.gov标识符，NCT01440101。
