Department of Epidemiology, Biostatistics and Prevention Institute, University of Zürich, Zürich, Switzerland/ Swiss Multiple Sclerosis Registry, Epidemiology, Biostatistics and Prevention Institute, University of Zürich, Zürich, Switzerland.
Clinical Trial Unit, University Hospital Basel, Basel, Switzerland.
Mult Scler. 2021 Mar;27(3):439-448. doi: 10.1177/1352458520918489. Epub 2020 May 28.
Disability progression independent of relapses (PIRA) has been described as a frequent phenomenon in relapsing-remitting multiple sclerosis (RRMS).
To compare the occurrence of disability progression in relapse-free RRMS patients on interferon-beta/glatiramer acetate (IFN/GA) versus fingolimod.
This study is based on data from the Swiss association for joint tasks of health insurers. Time to relapse and 12-month confirmed disability progression were compared between treatment groups using multivariable Cox regression analysis with confounder adjustment. Inverse-probability weighting was applied to correct for the bias that patients on fingolimod have a higher chance to remain relapse-free than patients on IFN/GA.
We included 1640 patients (64% IFN/GA, 36% fingolimod, median total follow-up time = 4-5 years). Disease-modifying treatment (DMT) groups were well balanced with regard to potential confounders. Disability progression was observed in 155 patients (8.8%) on IFN/GA and 51 (7.6%) on fingolimod, of which 44 and 23 were relapse-free during the initial DMT, respectively. Adjusted standard regression analysis on all patients indicated that those on fingolimod experience less frequently disability progression compared with IFN/GA (hazard ratio = 0.53 (95% confidence interval = 0.37-0.76)). After bias correction, this was also true for patients without relapses (hazard ratio=0.56 (95% confidence interval = 0.32-0.98).
Our analysis indicates that fingolimod is superior to IFN/GA in preventing disability progression in both relapsing , young, newly diagnosed RRMS patients.
复发缓解型多发性硬化症（RRMS）中，残疾进展与复发无关（PIRA）被描述为一种常见现象。
比较干扰素-β/醋酸格拉替雷（IFN/GA）与芬戈莫德治疗无复发 RRMS 患者的残疾进展发生率。
本研究基于瑞士联合健康保险公司协会的数据。采用多变量 Cox 回归分析，通过混杂因素调整比较治疗组之间的复发时间和 12 个月确认的残疾进展。应用逆概率加权法纠正偏倚，即芬戈莫德组患者保持无复发的可能性高于 IFN/GA 组患者。
我们纳入了 1640 名患者（64% IFN/GA，36%芬戈莫德，中位总随访时间=4-5 年）。DMT 组在潜在混杂因素方面具有良好的平衡性。在 IFN/GA 组中有 155 名（8.8%）和在芬戈莫德组中有 51 名（7.6%）患者发生残疾进展，其中 44 名和 23 名在初始 DMT 期间无复发。对所有患者进行的调整标准回归分析表明，与 IFN/GA 相比，芬戈莫德组发生残疾进展的频率较低（风险比=0.53（95%置信区间=0.37-0.76））。在偏倚校正后，对于无复发的患者也是如此（风险比=0.56（95%置信区间=0.32-0.98））。
我们的分析表明，在新发 RRMS 患者中，芬戈莫德在预防残疾进展方面优于 IFN/GA，无论是否有复发。
