Effect of interferon-β1α therapy on multiple sclerosis based on gadolinium-enhancing or active T2 magnetic resonance imaging outcomes: a meta-analysis

<b>Objectives:</b> Interferon-beta1alpha (IFN-β1α) is widely used to modify the course of relapsing-remitting multiple sclerosis. However, many patients have relapses. The purpose of this study was to evaluate magnetic resonance imaging (MRI) as a predictor of IFN-β1α treatment efficacy in patients with MS. <b>Methods:</b> PubMed, Embase, and the Cochrane Library were searched to identify eligible studies. Manual searches were also conducted. All eligible trials included MS patients who received IFN-β1α based on gadolinium-enhancing or active T2 MRI lesions for determination of relapse rates. <b>Results:</b> Of 499 identified studies, we included 10 trials reporting data on 6,037 MS patients. IFN-β1α therapy significantly reduced the risk of relapse (RR: 0.87; 95% confidence intervals (CI): 0.76–0.99; <i>p</i> = 0.032). Furthermore, baseline median T2 lesion volume was found to be related to IFN-β1α therapy and relapse (<i>p</i> = 0.018). Subgroup analysis suggested that IFN-β1α therapy was associated with reduced risk of relapse (RR: 0.82; 95%CI: 0.71–0.94; <i>p</i> = 0.005 versus placebo). However, there was no significant difference in the risk of relapse compared to treatment with low dose IFN-β1α (RR: 0.93; 95%CI: 0.80–1.08; <i>p</i> = 0.337) or glatiramer acetate (RR: 0.93; 95%CI: 0.77–1.14; <i>p</i> = 0.506). Finally, IFN-β1α therapy significantly increased the risk of injection-site disorders, influenza-like syndrome, and alanine transferase elevation. <b>Discussion:</b> Effects of IFN-β1α therapy are associated with a statistically significant impact on baseline median T2 lesion volume. However, the safety outcomes are significantly worse in patients who receive IFN-β1α therapy.

**研究目的**：干扰素β-1α（Interferon-beta1alpha，IFN-β1α）被广泛用于改善复发缓解型多发性硬化（relapsing-remitting multiple sclerosis）的病程，但仍有众多患者出现疾病复发。本研究旨在评估磁共振成像（magnetic resonance imaging，MRI）对多发性硬化（multiple sclerosis，MS）患者接受干扰素β-1α治疗疗效的预测价值。
**研究方法**：通过检索PubMed、Embase及Cochrane图书馆数据库以筛选符合纳入标准的研究，同时辅以手工检索。所有纳入的试验均纳入接受干扰素β-1α治疗的MS患者，以钆增强病灶或活动性T2加权MRI病灶作为复发率的判定依据。
**研究结果**：在初检出的499项研究中，最终纳入10项试验，共涉及6037例MS患者。干扰素β-1α治疗可显著降低疾病复发风险（相对危险度（relative risk，RR）=0.87；95%置信区间（confidence interval，CI）：0.76~0.99；*p*=0.032）。此外，基线T2病灶容积中位数与干扰素β-1α治疗及疾病复发存在相关性（*p*=0.018）。亚组分析显示，相较于安慰剂（placebo），干扰素β-1α治疗可降低疾病复发风险（相对危险度（relative risk，RR）=0.82；95%置信区间（confidence interval，CI）：0.71~0.94；*p*=0.005）。但与低剂量干扰素β-1α治疗（相对危险度（relative risk，RR）=0.93；95%置信区间（confidence interval，CI）：0.80~1.08；*p*=0.337）或醋酸格拉替雷（glatiramer acetate）治疗（相对危险度（relative risk，RR）=0.93；95%置信区间（confidence interval，CI）：0.77~1.14；*p*=0.506）相比，疾病复发风险无显著差异。最后，干扰素β-1α治疗会显著增加注射部位不良反应、类流感综合征及丙氨酸转氨酶（alanine transferase）升高的发生风险。
**讨论**：干扰素β-1α治疗的疗效与基线T2病灶容积中位数存在具有统计学意义的相关性，但接受干扰素β-1α治疗的患者的安全性结局显著更差。