ACROSS研究：芬戈莫德治疗复发缓解型多发性硬化症患者的长期疗效。
The ACROSS study: Long-term efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis.
作者信息
Derfuss T, Sastre-Garriga J, Montalban X, Rodegher M, Wuerfel J, Gaetano L, Tomic D, Azmon A, Wolf C, Kappos L
机构信息
Neurologic Clinic and Policlinic, University Hospital and University of Basel, Switzerland.
Multiple Sclerosis Centre of Catalonia (Cemcat), Department of Neurology/Neuroimmunology, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.
出版信息
Mult Scler J Exp Transl Clin. 2020 Mar 30;6(1):2055217320907951. doi: 10.1177/2055217320907951. eCollection 2020 Jan-Mar.
BACKGROUND
In chronic diseases such as multiple sclerosis requiring lifelong treatment, studies on long-term outcomes are important.
OBJECTIVE
To assess disability and magnetic resonance imaging-related outcomes in relapsing multiple sclerosis patients from a Phase 2 study of fingolimod 10 or more years after randomization and to compare outcomes in patients who had a higher fingolimod exposure versus those with a lower fingolimod exposure.
METHODS
ACROSS was a cross-sectional follow-up study of patients originally enrolled in a Phase 2 fingolimod proof-of-concept study (NCT00333138). Disability and magnetic resonance imaging-related outcomes were assessed in patients grouped according to fingolimod treatment duration, based on an arbitrary cut-off: ≥8 years (high exposure) and <8 years (low exposure).
RESULTS
Overall, 175/281 (62%) patients participated in ACROSS; 104 (59%) of these were classified "high exposure." At 10 years, patients in the high-exposure group had smaller increases in Expanded Disability Status Scale (+0.55 vs. +1.21), and lower frequencies of disability progression (34.7% vs. 56.1%), wheelchair use (4.8% vs. 16.9%), or transition to secondary progressive multiple sclerosis (9.6% vs. 22.5%) than those in the low-exposure group. The high-exposure patients also had less progression in most magnetic resonance imaging-related outcomes.
CONCLUSION
After 10 years of fingolimod treatment, disability progression was lower in the high-exposure group than in the low-exposure group.
背景
在诸如多发性硬化症这类需要终身治疗的慢性疾病中，关于长期预后的研究很重要。
目的
评估在随机分组10年或更长时间后，来自一项芬戈莫德2期研究的复发型多发性硬化症患者的残疾情况和磁共振成像相关预后，并比较芬戈莫德暴露量较高的患者与暴露量较低的患者的预后情况。
方法
ACROSS是一项对最初纳入芬戈莫德2期概念验证研究（NCT00333138）的患者进行的横断面随访研究。根据芬戈莫德治疗持续时间，基于一个任意设定的界限（≥8年（高暴露）和<8年（低暴露））对患者进行分组，并评估其残疾情况和磁共振成像相关预后。
结果
总体而言，281名患者中有175名（62%）参与了ACROSS研究；其中104名（59%）被归类为“高暴露”。在10年时，高暴露组患者的扩展残疾状态量表增加幅度较小（分别为+0.55和+1.21），残疾进展、使用轮椅或转变为继发进展型多发性硬化症的频率较低（分别为34.7%对56.1%；4.8%对16.9%；9.6%对22.5%）。高暴露患者在大多数磁共振成像相关预后方面的进展也较小。
结论
芬戈莫德治疗10年后，高暴露组的残疾进展低于低暴露组。
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