奥扎尼莫与其他口服 DMTs 在复发缓解型多发性硬化症中的有效性和安全性比较:匹配调整间接比较综述。

IF 4.7 2区 医学 Q1 CLINICAL NEUROLOGY Therapeutic Advances in Neurological Disorders Pub Date : 2024-06-07 eCollection Date: 2024-01-01 DOI:10.1177/17562864241237856
Damemarie Paul, Elyse Swallow, Oscar Patterson-Lomba, Tychell Branchcomb, Laetitia N'Dri, Andres Gomez-Lievano, Jingyi Liu, Akanksha Dua, Marisa McGinley
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引用次数: 0

摘要

背景:美国食品和药物管理局已批准多种口服改变病情疗法(DMT)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)可以评估奥扎尼莫德与其他口服DMTs在RRMS中的比较有效性和安全性:综合已发表的奥扎尼莫和其他口服DMTs在RRMS中2年疗效的MAIC结果:方法:对已发表的涉及奥扎尼莫治疗RRMS的MAIC进行鉴定。提取的数据元素包括疗效[年复发率(ARR)、确诊残疾进展(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:四项MAIC研究对奥扎尼莫德与芬戈莫德、特立氟胺、富马酸二甲酯(DMF)和波奈莫德进行了比较。所有比较均根据年龄、性别、前一年内复发情况、残疾状况扩展量表评分以及曾接受过 DMTs 治疗的患者比例的差异进行了调整。根据缺乏共同参照组的比较结果分析了2年后的结果。与特立氟胺相比,奥扎尼莫的ARR明显较低[ARR比值(95% CI)为0.73 (0.62, 0.84),DMF为0.80 (0.67, 0.97)],与芬戈莫德或泼尼莫德相比则无明显差异。接受奥扎莫德或芬戈莫德治疗的患者中,3个月和6个月的CDP比例相似。与特立氟胺和DMF相比,奥扎莫德的3个月CDP风险明显较低;6个月CDP风险相当。与其他接受评估的口服 DMT 相比,奥扎尼莫的任何 AE 和导致停药的 AE 发生率都明显较低。与特立氟胺和DMF相比,奥扎尼莫的SAE发生率也明显较低;与芬戈莫德和泼尼莫德相比,奥扎尼莫的感染报告率也较低:结论:与 MAICs 中评估的其他口服 DMT 相比,奥扎尼莫具有良好的安全性,疗效也有所改善或相当。
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Comparative effectiveness and safety of ozanimod versus other oral DMTs in relapsing-remitting multiple sclerosis: a synthesis of matching-adjusted indirect comparisons.

Background: 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.

Objectives: To synthesize results from the published MAICs of ozanimod and other oral DMTs for 2-year outcomes in RRMS.

Methods: 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.

Results: 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.

Conclusion: Compared with the other oral DMTs evaluated in MAICs, ozanimod was associated with a favorable safety profile and improved or comparable efficacy outcomes.

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来源期刊
CiteScore
8.30
自引率
1.70%
发文量
62
审稿时长
15 weeks
期刊介绍: Therapeutic Advances in Neurological Disorders is a peer-reviewed, open access journal delivering the highest quality articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of neurology. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in neurology, providing a forum in print and online for publishing the highest quality articles in this area.
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