Onset of clinical and MRI efficacy of ocrelizumab in relapsing multiple sclerosis

Objective: To assess the onset of ocrelizumab efficacy on brain magnetic resonance imaging (MRI) measures of disease activity in the Phase II study in relapsing-remitting multiple sclerosis (RRMS), and relapse rate in the pooled Phase III studies in relapsing multiple sclerosis (RMS). Methods: Brain MRI activity was determined in the Phase II trial at monthly intervals in patients with RRMS receiving placebo, ocrelizumab (600 mg), or intramuscular interferon (IFN) β-1a (30 μg). Annualized relapse rate (ARR; over various epochs) and time to first relapse were analyzed in the pooled population of the Phase III OPERA I and OPERA II trials in patients with RMS receiving ocrelizumab (600 mg) or subcutaneous IFN β-1a (44 μg). Results: In patients with RRMS, ocrelizumab reduced the number of new T1 gadolinium-enhancing lesions by Week 4 vs placebo (p=0.042) and by Week 8 vs intramuscular IFN β-1a (p&lt;0.001). Ocrelizumab also reduced the number of new or enlarging T2 lesions appearing ...研究目标：针对复发缓解型多发性硬化（relapsing-remitting multiple sclerosis, RRMS）患者开展的II期临床试验中，评估奥瑞珠单抗（ocrelizumab）对脑部磁共振成像（magnetic resonance imaging, MRI）疾病活性指标的起效效果；同时针对复发型多发性硬化（relapsing multiple sclerosis, RMS）患者的汇总III期临床试验中，评估其对复发率的影响。 研究方法：在针对RRMS患者的II期临床试验中，按月监测接受安慰剂、奥瑞珠单抗（600mg）或肌内注射干扰素（interferon, IFN）β-1a（30μg）的患者的脑部MRI疾病活性。针对接受奥瑞珠单抗（600mg）或皮下注射IFN β-1a（44μg）的RMS患者，对III期OPERA I与OPERA II临床试验的汇总人群，分析其年化复发率（annualized relapse rate, ARR；涵盖多个随访周期）及首次复发时间。 研究结果：在RRMS患者中，奥瑞珠单抗可较安慰剂组在第4周时减少新增T1加权钆增强病灶数量（p=0.042）；较肌内注射IFN β-1a组在第8周时实现该效果（p<0.001）。此外，奥瑞珠单抗还可减少新发或增大的T2加权病灶数量……