Open AccessDisease-activity-free status in patients with relapsing–remitting multiple sclerosis treated with daclizumab high-yield process in the SELECT study
Author(s) -
Eva Havrdová,
Gavin Giovani,
Dusan Stefoski,
Samantha Vettese Forster,
Kimberly Umans,
Lahar Mehta,
Steven J. Greenberg,
Jacob Elkins
Publication year - 2013
Publication title -
multiple sclerosis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.729
H-Index - 131
eISSN - 1477-0970
pISSN - 1352-4585
DOI - 10.1177/1352458513502113
Subject(s) - medicine , placebo , daclizumab , multiple sclerosis , odds ratio , confidence interval , gastroenterology , expanded disability status scale , relapsing remitting , clinical trial , surgery , disease , pathology , immunology , transplantation , alternative medicine , tacrolimus
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.