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那他珠单抗和芬戈莫德治疗复发缓解型多发性硬化症的真实世界疗效。一项意大利多中心研究。

The real-world effectiveness of natalizumab and fingolimod in relapsing-remitting multiple sclerosis. An Italian multicentre study.

机构信息

Neurosciences Unit, Department of Medicine and Surgery, University of Parma, via Gramsci 14, Parma 43126, Italy.

Neurosciences Unit, Department of Medicine and Surgery, University of Parma, via Gramsci 14, Parma 43126, Italy.

出版信息

Mult Scler Relat Disord. 2019 Aug;33:146-152. doi: 10.1016/j.msard.2019.05.026. Epub 2019 May 31.

DOI:10.1016/j.msard.2019.05.026
PMID:31200271
Abstract

BACKGROUND

Both natalizumab and fingolimod are highly effective in the treatment of relapsing-remitting MS (RRMS). In the absence of head-to-head trials, some observational studies have compared their efficacy with conflicting results.

OBJECTIVES

To investigate the efficacy of natalizumab and fingolimod in a cohort of RRMS patients in an observational, retrospective study.

METHODS

We included all consecutive RRMS patients who started natalizumab or fingolimod in three MS centres with a follow-up to 24 months and analysed clinical and brain MRI data after propensity score (PS) matching.

RESULTS

After 1:1 PS-matching, we retained 102 patients in both groups, with similar baseline features. After 24 months, although both drugs resulted highly effective, patients treated with natalizumab had a lower relapse risk (HR 0.59 CI 95% 0.35-1.00, p = 0.048) and higher time to first relapse. MRI-combined-unique-activity was found in 31.8% of natalizumab vs 43.2% of fingolimod treated patients (p = 0.28). We found a higher proportion of patients with confirmed regression of disability (19.2 vs 6.7%, p = 0.03) and 2-year no evidence of disease activity (NEDA-3, 39.0% vs 22.0%, p = 0.04) in the natalizumab group.

CONCLUSIONS

Both drugs were highly effective in our cohort. Natalizumab proved superior in inducing regression of disability and 2-year-NEDA-3.

摘要

背景

那他珠单抗和芬戈利莫德在治疗复发缓解型多发性硬化症(RRMS)方面均具有显著疗效。由于缺乏头对头试验,一些观察性研究比较了这两种药物的疗效,结果存在差异。

目的

在一项观察性、回顾性研究中,调查那他珠单抗和芬戈利莫德在 RRMS 患者队列中的疗效。

方法

我们纳入了在三个 MS 中心接受那他珠单抗或芬戈利莫德治疗的所有连续 RRMS 患者,随访 24 个月,在进行倾向评分(PS)匹配后分析临床和脑 MRI 数据。

结果

在 1:1 PS 匹配后,我们保留了两组各 102 例患者,基线特征相似。24 个月后,尽管两种药物均具有高度疗效,但接受那他珠单抗治疗的患者复发风险较低(HR 0.59 CI 95% 0.35-1.00,p=0.048),且首次复发时间更长。MRI 综合独特活动(MRI-U)在那他珠单抗组中为 31.8%,而在芬戈利莫德组中为 43.2%(p=0.28)。我们发现,在那他珠单抗组中,有更多的患者出现残疾确有改善(19.2%比 6.7%,p=0.03)和 2 年无疾病活动(NEDA-3)(39.0%比 22.0%,p=0.04)。

结论

在我们的队列中,这两种药物均具有高度疗效。那他珠单抗在诱导残疾改善和 2 年 NEDA-3 方面更具优势。

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