Escalation to natalizumab or switching among immunomodulators in relapsing multiple sclerosis
Escalation to natalizumab or switching among immunomodulators in relapsing multiple sclerosis
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DOI：
10.1177/1352458511417481
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发表时间：
2012-01-01
影响因子：
5.8
通讯作者：
Gasperini, Claudio
中科院分区：
文献类型：
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作者：
Prosperini, Luca;Gianni, Costanza;Gasperini, Claudio
目的：评估在复发-缓解型多发性硬化症（RRMS）患者中，升级治疗是否比切换免疫调节剂更有效地抑制临床和磁共振成像（MRI）活性。方法：在两家意大利多发性硬化症（MS）中心进行的这项上市后前瞻性观察性研究中，共有285名接受干扰素β (IFN β)或醋酸格拉替默（GA）一线治疗失败的RRMS患者被纳入研究对象。根据失败后采取的策略（定义为>= 2次复发或1次复发并残留残疾）对患者进行细分：切换（SWI）组，即在不同的IFN β制剂之间切换，或从IFN β到GA，反之亦然；和升级（ESC）组，即升级到那他珠单抗的组。在12个月和24个月时计算没有不同类型疾病活动（复发、持续残疾进展、MRI上新的活动性病变或它们的组合）的患者的比例。由于患者没有随机分配到治疗组，因此建立了倾向评分（PS）校正的Cox回归模型来控制几个潜在的混杂因素。结果：在12个月时，两组无复发、无残疾进展、无MRI活动和无联合活动的患者比例无差异。24个月后，我们观察到ESC组患者比SWI组患者无复发的比例更高(p
Objective: To evaluate whether an escalation approach was more effective in suppressing clinical and magnetic resonance imaging (MRI) activity than switching among immunomodulators in relapsing-remitting multiple sclerosis (RRMS) patients.Methods: In this post-marketing, prospective, observational study in two Italian multiple sclerosis (MS) centres, a total of 285 RRMS patients who failed a first-line treatment with interferon beta (IFN beta) or glatiramer acetate (GA) were considered. Patients were subdivided according to the strategy adopted after the failure (defined as the occurrence of >= 2 relapses or 1 relapse with residual disability): the switching (SWI) group, i.e. those switched among different IFN beta formulations, or from IFN beta to GA and vice versa; and the escalating (ESC) group, i.e. those escalated to natalizumab. Proportions of patients free from different types of disease activity (relapses, sustained disability progression, new active lesions on MRI, or a combination of them) were calculated at 12 and 24 months. Since patients were not randomized to treatment group, propensity score (PS)-adjusted Cox regression models were built to control for several potential confounders.Results: At 12 months there were no differences between the two groups in proportions of patients free from relapse, disability progression, MRI activity, and combined activity. After 24 months we observed greater proportions of patients in the ESC than SWI group free from relapse (p