期刊
MULTIPLE SCLEROSIS JOURNAL
卷 20, 期 4, 页码 464-470出版社
SAGE PUBLICATIONS LTD
DOI: 10.1177/1352458513502113
关键词
Relapsing-remitting multiple sclerosis; induction of remission; clinical endpoints; radiological endpoints; magnetic resonance imaging
资金
- Biogen Idec
- AbbVie Biotherapeutics
- Czech Ministry of Education [VZ MSM 0021620849, PRVOUK-P26/LF1/4]
Background: Daclizumab high-yield process (DAC HYP) is a humanized anti-CD25 monoclonal antibody that inhibits high-affinity interleukin-2 receptor signaling. Objective: The objective of this paper is to assess the proportion of DAC HYP- versus placebo-treated patients who were free from disease activity. Methods: SELECT was a randomized, double-blind, multicenter study of DAC HYP 150 mg or 300 mg, or placebo, administered subcutaneously every four weeks for 52 weeks. In this post-hoc analysis of the SELECT trial, 'disease-activity free' was defined as completion through week 52 without relapses or confirmed three-month disability progression (clinical), with no new/newly enlarging T2-hyperintense lesions and no new gadolinium-enhancing lesions at the week 52 scan (radiological). Primary analyses were based on logistic regression controlling for baseline characteristics. Results: More DAC HYP- treated (39%, n = 156) versus placebo-treated patients (11%, n = 22) were disease-activity free (odds ratio (95% confidence interval), 6.18 (3.71-10.32); p < 0.0001). Furthermore, 77% and 48% of DAC HYP-treated patients were free from clinical or radiological disease activity, respectively, compared with 60% and 18% of placebo-treated patients. Conclusion: At one year, DAC HYP resulted in a meaningful increase in the proportion of relapsing-remitting MS patients who were disease-activity free versus placebo.
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