作者: M. P. Sormani , D. K. Li , P. Bruzzi , B. Stubinski , P. Cornelisse
DOI: 10.1212/WNL.0B013E31823648B9
关键词: Internal medicine 、 Interferon therapy 、 Surgery 、 Disability progression 、 Lesion 、 Multiple sclerosis 、 Clinical trial 、 Expanded Disability Status Scale 、 Time course 、 Patient data 、 Medicine
摘要: Objective: In multiple sclerosis (MS), the aim of therapies is to prevent accumulation irreversible disability. This difficult assess given short time course clinical trials. MRI markers and relapses are often used as surrogate disability in MS studies, but their validity remains controversial. We sought validate, at individual patient level, lesions surrogates for progression over Methods: Individual data from a large, placebo-controlled trial interferon β-1a relapsing-remitting (RRMS) were analyzed. The Prentice criteria applied evaluate surrogacy 1-year active worsening (Expanded Disability Status Scale [EDSS]) 2-year follow-up. Results: All satisfied. Treatment reduced by 31% odds having EDSS 2 years, reducing mean number 61% 36% 1 year. Both lesion activity relapses, when considered independently, accounted more than 60% treatment effect on worsening. A combination explained 100% years. Conclusions: combined measure changes after therapy fully estimated corresponding short-term appears be longer term evaluating RRMS.