几种口腔疾病改善疗法(DMT)已被食品和药物管理局批准用于治疗复发缓解型多发性硬化症(RRMS)。在缺乏头对头随机数据的情况下,匹配调整间接比较(MAIC)可以评估奥扎马德与其他口服DMT在RRMS中的比较有效性和安全性.
■从已发布的ozanimod和其他口腔DMT的MAIC中综合结果,以RRMS为2年结果。
■确定了涉及ozanimod治疗RRMS的已发布的MAIC。提取的数据元素包括疗效[年度复发率(ARR),确认残疾进展(CDP),和脑容量损失]和安全性[不良事件(AE),严重不良事件(SAE),导致停药的不良事件,和感染]结果。
■四个MAIC研究确定比较了奥扎马德和芬戈莫德,特立氟胺,富马酸二甲酯(DMF),还有ponesimod.所有比较都根据年龄差异进行了调整,性别,在前一年内复发,扩展的残疾状况量表评分,以及既往DMT患者的百分比。2年的结果是根据缺乏共同比较臂的比较进行分析的。与特立氟胺相比,奥扎马德的ARR显着降低[ARR比率(95%CI)0.73(0.62,0.84)和DMF0.80(0.67,0.97)],与芬戈莫德或ponesimod没有显着差异。接受奥扎马德或芬戈莫德治疗的患者的3个月和6个月CDP的比例相似。与特立氟胺和DMF相比,ozanimod与3个月CDP的风险显着降低相关;6个月CDP具有可比性。与评估的其他口服DMT相比,Ozanimod与导致停药的任何AE和AE的发生率显着降低相关。与特立氟胺和DMF相比,Ozanimod的SAE发生率也显着较低,与芬戈莫德和ponesimod相比,报告的感染结果发生率较低。
■与在MAIC中评估的其他口腔DMT相比,ozanimod具有良好的安全性和改善或相当的疗效结局.
在复发缓解型多发性硬化症中,奥扎马德与其他口服治疗的间接比较复发缓解型多发性硬化症(RRMS)的许多治疗选择使治疗决策变得困难。虽然直接头对头治疗比较提供了有用的信息,这些研究并不适用于每一对治疗。对已发表的研究结果进行间接比较可以帮助填补这一证据空白。一种称为匹配调整间接比较(MAIC)的技术通过考虑研究中的重要差异,提供了一种统计上可靠的方法来比较不同研究的安全性/有效性结果。我们收集了四项MAIC研究的数据,这些研究比较了使用奥扎马德治疗的患者与使用芬戈莫德治疗的患者的2年治疗结果,特立氟胺,富马酸二甲酯(DMF),或者ponesimod.每一项研究都说明了年龄的差异,性别,在前一年内复发,残疾状况,和以前的治疗方法。根据测量的结果,我们发现ozanimod比其他治疗方法更好或相似。接受奥扎尼莫德治疗的患者的RRMS年复发率低于接受特立氟胺或DMF治疗的患者,而接受ponesimod或fingolimod治疗的患者的RRMS年复发率相似。Ozanimod治疗的患者在3个月和6个月时的RRMS进展速度与使用芬戈莫德治疗的患者相似,在6个月时使用特立氟胺和DMF治疗的患者的RRMS在3个月时更有可能进展。我们的分析还发现,接受奥扎马德治疗的患者副作用发生率较低,包括那些严重到导致治疗中断的,与接受其他治疗的患者相比。通过比较现有MAIC研究的结果,我们发现,与接受其他RRMS治疗的患者相比,接受奥扎马德治疗的RRMS患者的副作用更少,疗效结局更好或相似.这些发现可能为RRMS患者的治疗决策提供信息。
UNASSIGNED: Several oral disease-modifying therapies (DMTs) have been approved by the Food and Drug Administration for the treatment of relapsing-remitting multiple sclerosis (RRMS). In the absence of head-to-head randomized data, matching-adjusted indirect comparisons (MAICs) can evaluate the comparative effectiveness and safety of ozanimod versus other oral DMTs in RRMS.
UNASSIGNED: To synthesize results from the published MAICs of ozanimod and other oral DMTs for 2-year outcomes in RRMS.
UNASSIGNED: Published MAICs involving ozanimod for the treatment of RRMS were identified. Extracted data elements included efficacy [annualized relapse rate (ARR), confirmed disability progression (CDP), and brain volume loss] and safety [adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, and infection] outcomes.
UNASSIGNED: The four MAIC studies identified compared ozanimod with fingolimod, teriflunomide, dimethyl fumarate (DMF), and ponesimod. All comparisons were adjusted for differences in age, sex, relapses within the previous year, Expanded Disability Status Scale score, and percentage of patients with prior DMTs. Outcomes at 2 years were analyzed based on comparisons that lacked a common comparator arm. Ozanimod was associated with significantly lower ARR versus teriflunomide [ARR ratio (95% CI) 0.73 (0.62, 0.84) and DMF 0.80 (0.67, 0.97)], with no significant difference versus fingolimod or ponesimod. The proportions of patients treated with ozanimod or fingolimod had similar 3- and 6-month CDP. Compared with teriflunomide and DMF, ozanimod was associated with a significantly lower risk of 3-month CDP; 6-month CDP was comparable. Ozanimod was associated with significantly lower rates of any AE and AEs leading to discontinuation compared with the other oral DMTs evaluated. Ozanimod also had significantly lower rates of SAEs versus teriflunomide and DMF and lower rates of reported infection outcomes versus fingolimod and ponesimod.
UNASSIGNED: Compared with the other oral DMTs evaluated in MAICs, ozanimod was associated with a favorable safety profile and improved or comparable efficacy outcomes.
An indirect comparison of ozanimod vs other oral treatments in relapsing-remitting multiple sclerosis The many treatment options available for relapsing-remitting multiple sclerosis (RRMS) make treatment decisions difficult. While direct head-to-head treatment comparisons provide useful information, these studies are not available for every pair of treatments. Indirect comparisons of published study results can help fill that evidence gap. A technique called matching-adjusted indirect comparison (MAIC) offers a statistically robust way to compare safety/efficacy outcomes from different studies by accounting for important differences across the studies. We collected data from four MAIC studies that compared 2-year treatment outcomes in patients treated with ozanimod versus those treated with fingolimod, teriflunomide, dimethyl fumarate (DMF), or ponesimod. Each study accounted for differences in age, sex, relapses within the previous year, disability status, and previous therapy use. We found ozanimod was either better than or similar to other treatments based on the outcomes measured. The annual rate of RRMS relapse was lower for patients treated with ozanimod than for patients treated with teriflunomide or DMF and similar for patients treated with ponesimod or fingolimod. Ozanimod-treated patients saw their RRMS progress at rates similar to those treated with fingolimod at 3 and 6 months and teriflunomide and DMF at 6 months; RRMS was more likely to progress at 3 months in patients treated with teriflunomide and DMF versus those treated with ozanimod. Our analyses also found that patients treated with ozanimod had lower rates of side effects, including those serious enough to cause treatment discontinuation, compared with patients receiving other treatments. By comparing findings from existing MAIC studies, we found that patients with RRMS treated with ozanimod had fewer side effects and better or similar efficacy outcomes compared with patients who received other treatments for RRMS. These findings can potentially inform treatment decisions for patients with RRMS.