Rituximab versus Ocrelizumab in Newly Diagnosed Relapsing Multiple Sclerosis.

However, data from head-to-head trials are lacking.

然而，缺乏直接比较试验的数据。

Methods

In this phase 3, multicenter, double-blind, noninferiority trial, we randomly assigned adults with newly diagnosed relapsing multiple sclerosis and recent disease activity in a 3:2 ratio to receive rituximab or ocrelizumab every 6 months for 24 months.

在这项III期、多中心、双盲、非劣效试验中，我们以3:2的比例随机分配了新诊断的复发性多发性硬化症成人患者，并在最近有疾病活动的情况下，每6个月接受利妥昔单抗或奥克珠单抗治疗，为期24个月。

The primary end point was the absence of new or enlarging lesions on T2-weighted magnetic resonance imaging (MRI) from month 6 to month 24.

主要终点是从第6个月到第24个月，在T2加权磁共振成像（MRI）上没有新的或扩大的病变。

Noninferiority was defined as a lower limit of the 95% confidence intervalfor the risk difference (rituximab minus ocrelizumab) of greater than or equal to -10 percentage points.

非劣效性被定义为风险差异（利妥昔单抗减去奥克珠单抗）的95%置信区间下限大于或等于-10个百分点。

Secondary end points included efficacy and safety.

次要终点包括疗效和安全性。

Results

A total of 218 participants underwent randomization; 216 received treatment (132 assigned to the rituximab group and 84 assigned to the ocrelizumab group).

共有218名参与者进行了随机分组；216人接受了治疗（132人被分配到利妥昔单抗组，84人被分配到奥瑞珠单抗组）。

Between months 6 and 24, the estimated probability of having no new or enlarging lesions detected on T2-weighted MRI was 92.2% with rituximab and 94.8% with ocrelizumab, corresponding to a risk difference of -2.6 percentage points (95% confidence interval, -9.4 to 4.3), which met the prespecified noninferiority criterion.

在第6个月至第24个月期间，使用T2加权MRI检测到无新发或增大的病变的概率，利妥昔单抗组为92.2%，奥瑞珠单抗组为94.8%，风险差异为-2.6个百分点（95%置信区间，-9.4至4.3），满足了预先设定的非劣效性标准。

Relapse rates, disability outcomes, and cognitive-performance profiles appeared to be similar in the two groups.

两组的复发率、残疾结果和认知表现概况似乎相似。

Infections were more common in the rituximab group than in the ocrelizumab group (in 82% vs. 69% of participants), although the percentage of participants with serious adverse events was similar in the two groups (8% and 7%, respectively).

利妥昔单抗组的感染发生率高于奥瑞珠单抗组（分别占参与者总数的82%和69%），尽管两组中严重不良事件的发生率相似（分别为8%和7%）。

Conclusions

In participants with newly diagnosed relapsing multiple sclerosis and recent disease activity, rituximab was noninferior to ocrelizumab in suppressing disease activity as detected by MRI from 6 to 24 months, with a similar incidenceof serious adverse events.

在新诊断的复发性多发性硬化症患者中，且近期有疾病活动的参与者中，从6个月到24个月，利妥昔单抗在抑制MRI检测到的疾病活动方面不劣于奥克珠单抗，严重不良事件的发生率相似。

(Funded by the Research Council of Norway and others; OVERLORD-MS ClinicalTrials.gov number, NCT04578639; EudraCT number, 2020-001205-23; EU Clinical Trials Register number, 2024-510716-71-00.).

该项目由挪威研究委员会和其他机构资助；OVERLORD-MS临床试验注册号为NCT04578639；EudraCT编号为2020-001205-23；欧盟临床试验注册号为2024-510716-71-00。