Tur Carmen, Montalban Xavier, Tintoré Mar, Nos Carlos, Río Jordi, Aymerich Francesc Xavier, Brieva Luis, Téllez Nieves, Perkal Héctor, Comabella Manuel, Galán Ingrid, Calle David, Sastre-Garriga Jaume, Rovira Alex
Multiple Sclerosis Centre of Catalonia, Autonomous University of Barcelona, Centre d'Anàlisi i Recerca en Neuroimatge i Esclerosi Mùltiple-Vall d'Hebron University Hospital, Escola Universitària d'Infermeria 2ª Planta, Passeig de la Vall d'Hebron 119-129, 08035 Barcelona, Spain.
Arch Neurol. 2011 Nov;68(11):1421-7. doi: 10.1001/archneurol.2011.241.
To investigate, during the 5-year period without treatment after termination of a 2-year clinical trial of interferon beta-1b for the treatment of primary progressive multiple sclerosis, differences in the evolution of clinical variables and magnetic resonance imaging results between trial arms and to investigate correlations between in-trial changes in Multiple Sclerosis Functional Composite (MSFC) score and magnetic resonance imaging variables and Expanded Disability Status Scale (EDSS) score evolution.
Five-year clinical trial follow-up.
Clinical Neuroimmunology Unit, Multiple Sclerosis Centre of Catalonia, Autonomous University of Barcelona, Spain. Patients Seventy-three patients received interferon beta-1b or placebo during the trial.
After 5 years without treatment, the EDSS and MSFC measures were scored for 63 and 59 patients, respectively. Neuropsychological and magnetic resonance imaging assessments were performed for 59 and 50 patients, respectively.
After 5 years without treatment, the interferon beta-1b group had better 9-Hole Peg Test (P = .02) and Word List Generation Test (P < .001) scores, and their magnetization transfer ratio measures in the normal-appearing white matter were significantly higher (P = .02, P = .009, and P = .03 for the mean, peak location, and peak height magnetic transfer ratios, respectively). During the entire study period (from trial baseline to assessment at 5 years without treatment), the placebo group showed a greater decrease in brain parenchymal fraction (P = .004). The in-trial increase of lesions correlated with the worsening of the EDSS score during the 5-year period without treatment (P = .004).
Modest but beneficial effects of interferon beta-1b on clinical variables and brain atrophy development were observed 5 years after trial termination. Moreover, in-trial lesion activity correlated with EDSS progression after trial termination. Therefore, we provide evidence to consider immunomodulation as a sensible approach to treat primary progressive multiple sclerosis.
在为期2年的干扰素β-1b治疗原发性进展型多发性硬化症的临床试验结束后，对未经治疗的5年期间进行研究，以探讨试验组之间临床变量演变和磁共振成像结果的差异，并研究试验期间多发性硬化功能复合量表（MSFC）评分变化与磁共振成像变量及扩展残疾状态量表（EDSS）评分演变之间的相关性。
5年临床试验随访。
西班牙巴塞罗那自治大学加泰罗尼亚多发性硬化症中心临床神经免疫学单元。患者：73名患者在试验期间接受了干扰素β-1b或安慰剂治疗。
在未经治疗的5年后，分别对63名和59名患者进行了EDSS和MSFC测量。分别对59名和50名患者进行了神经心理学和磁共振成像评估。
在未经治疗的5年后，干扰素β-1b组的9孔插钉试验（P = 0.02）和单词表生成试验（P < 0.001）得分更高，其正常表现白质中的磁化传递率测量值显著更高（平均、峰值位置和峰值高度磁化传递率分别为P = 0.02、P = 0.009和P = 0.03）。在整个研究期间（从试验基线到未经治疗的5年评估），安慰剂组的脑实质分数下降幅度更大（P = 0.004）。试验期间病变的增加与未经治疗的5年期间EDSS评分的恶化相关（P = 0.004）。
试验终止5年后，观察到干扰素β-1b对临床变量和脑萎缩发展有适度但有益的影响。此外，试验期间的病变活动与试验终止后的EDSS进展相关。因此，我们提供了证据，支持将免疫调节作为治疗原发性进展型多发性硬化症的合理方法。
