摘要
Objective: To evaluate the efficacy and safety of interferon beta- 1b (IFNβ - 1b) in subjects with secondary progressive multiple sclerosis (SPMS). Methods: This 3- year, multicenter, double- blind, placebo- controlled, randomized trial of IFNβ - 1b included 939 subjects from the United States and Canada with SPMS and Expanded Disability Status Scale (EDSS) scores ranging from 3.0 to 6.5. Subjects were randomly assigned to receive either placebo or IFNβ - 1b (250 μ g or 160 μ g/m2 body surface area), administered subcutaneously every other day. The primary outcome was time to progression by ≥ 1.0 EDSS point (0.5 point if EDSS score was 6.0 to 6.5 at entry)- confirmed at 6 months. Secondary outcomes included mean change in EDSS score from baseline, relapse- related measures, MRI activity, and a standardized neuropsychological function test. Results: There was no significant difference in time to confirmed progression of EDSS scores between placebo- treated patients and either of the IFNβ - 1b treatment groups. However, IFNβ - 1b treatment resulted in improvement on secondary outcome measures involving clinical relapses, newly active MRI lesions, and accumulated burden of disease on T2- weighted MRI. Effects were similar for both IFNβ - 1b treatment groups. Neutralizing antibodies to IFNβ - 1b were detected in 23% of 250- μ g and 32% of 160- μ g/m2 recipients, but their presence did not consistently affect clinical or MRI outcomes. IFNβ - 1b was also well tolerated at both doses. Conclusions: Although no treatment benefit was seen on the time to confirmed progression of disability, relapse- and MRI- related outcomes showed significant benefit with both dosing regimens tested, a result consistent with the outcomes of earlier clinical trials.
Objective: To evaluate the efficacy and safety of interferon beta- 1b (IFNβ - 1b) in subjects with secondary progressive multiple sclerosis (SPMS). Methods: This 3- year, multicenter, double- blind, placebo- controlled, randomized trial of IFNβ - 1b included 939 subjects from the United States and Canada with SPMS and Expanded Disability Status Scale (EDSS) scores ranging from 3.0 to 6.5. Subjects were randomly assigned to receive either placebo or IFNβ - 1b (250 μ g or 160 μ g/m2 body surface area), administered subcutaneously every other day. The primary outcome was time to progression by ≥ 1.0 EDSS point (0.5 point if EDSS score was 6.0 to 6.5 at entry)- confirmed at 6 months. Secondary outcomes included mean change in EDSS score from baseline, relapse- related measures, MRI activity, and a standardized neuropsychological function test. Results: There was no significant difference in time to confirmed progression of EDSS scores between placebo- treated patients and either of the IFNβ - 1b treatment groups. However, IFNβ - 1b treatment resulted in improvement on secondary outcome measures involving clinical relapses, newly active MRI lesions, and accumulated burden of disease on T2- weighted MRI. Effects were similar for both IFNβ - 1b treatment groups. Neutralizing antibodies to IFNβ - 1b were detected in 23% of 250- μ g and 32% of 160- μ g/m2 recipients, but their presence did not consistently affect clinical or MRI outcomes. IFNβ - 1b was also well tolerated at both doses. Conclusions: Although no treatment benefit was seen on the time to confirmed progression of disability, relapse- and MRI- related outcomes showed significant benefit with both dosing regimens tested, a result consistent with the outcomes of earlier clinical trials.
出处
《世界核心医学期刊文摘（神经病学分册）》
2005年第4期36-37,共2页
Digest of the World Core Medical Journals:Clinical Neurology
