Disease-activity-free status in patients with relapsing-remitting multiple sclerosis treated with daclizumab high-yield process in the SELECT study

作者：Havrdova Eva^*; Giovannoni Gavin; Stefoski Dusan; Forster Samantha; Umans Kimberly; Mehta Lahar; Greenberg Steven; Elkins Jacob

来源：Multiple Sclerosis, 2014, 20(4): 464-470.

DOI：10.1177/1352458513502113

• Relapsing-remitting multiple sclerosis
• induction of remission
• clinical endpoints
• radiological endpoints
• magnetic resonance imaging

Background: Daclizumab high-yield process (DAC HYP) is a humanized anti-CD25 monoclonal antibody that inhibits high-affinity interleukin-2 receptor signaling. %26lt;br%26gt;Objective: The objective of this paper is to assess the proportion of DAC HYP- versus placebo-treated patients who were free from disease activity. %26lt;br%26gt;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, %26apos;disease-activity free%26apos; 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. %26lt;br%26gt;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 %26lt; 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. %26lt;br%26gt;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.

• 出版日期2014-4