Department of Neurology, Division of Neuroscience, Institute of Experimental Neurology, San Raffaele Scientific Institute, Milan, Italy.
Eur J Neurol. 2013 Jul;20(7):1060-7. doi: 10.1111/ene.12119. Epub 2013 Feb 20.
It is still unclear which patients benefit more from available disease-modifying treatments (DMTs) in multiple sclerosis (MS). Our objective is to identify the baseline clinical and magnetic resonance imaging (MRI) predictors of response to first-line DMTs in a cohort of relapsing-remitting (RR) MS patients in a real-world clinical setting.
Consecutive naïve RRMS patients treated with interferon-beta or glatiramer acetate have been included and followed for 2 years. Patients were grouped into responders (R) in case of absence of clinical and MRI activity, and non-responders (NR) if the on-treatment annualized relapse rate (ARR) reduction was < 50% of the ARR in the 2 years before treatment or in the presence of MRI activity (≥ 2 active lesions at 1-year MRI or ≥ 4 active lesions at 1 + 2-year MRI).
At 2-year follow-up, 272 patients were R (34.6%) and 322 NR (40.9%), and multivariate analysis revealed that a later age at onset of the disease (P < 0.0001), a lower disability (P < 0.0001) and a lower number of gadolinium-enhancing lesions at baseline MRI (P = 0.002) were predictors of efficacy of DMTs. Moreover, the first year response had a good predictive power on the second year, as 73.7% of 1-year R had no evidence of clinical and MRI activity within the ensuing year.
A lower baseline MRI and clinical activity have been identified as predictors of DMT efficacy in patients with RRMS in routine clinical practice. Evaluation of clinical and MRI activity at 1 year is recommended to monitor patients over time.
目前仍不清楚多发性硬化症（MS）患者中哪些患者能从现有的疾病修正治疗（DMT）中获益更多。我们的目的是在真实临床环境中，确定复发缓解型（RR）MS 患者接受一线 DMT 治疗时的基线临床和磁共振成像（MRI）预测指标。
纳入了连续接受干扰素-β或醋酸格拉替雷治疗的初治 RRMS 患者，并进行了 2 年的随访。患者被分为应答者（R）和非应答者（NR）。如果治疗期间的年复发率（ARR）降低<治疗前 2 年的 ARR 的 50%，或存在 MRI 活动（1 年 MRI 时≥2 个活跃病灶或 1+2 年 MRI 时≥4 个活跃病灶），则为 NR。
在 2 年随访时，272 例患者为 R（34.6%），322 例患者为 NR（40.9%）。多变量分析显示，疾病发病年龄较晚（P<0.0001）、残疾程度较低（P<0.0001）和基线 MRI 时钆增强病灶较少（P=0.002）是 DMT 疗效的预测指标。此外，第 1 年的反应对第 2 年有很好的预测能力，因为 73.7%的第 1 年 R 在随后的 1 年内没有临床和 MRI 活动的证据。
在常规临床实践中，RRMS 患者的基线 MRI 和临床活动较低被确定为 DMT 疗效的预测指标。建议在第 1 年评估临床和 MRI 活动，以监测患者随时间的变化。
