Decrease in T1 Black Hole Volume Over 2 Years of Daclizumab High-Yield Process Treatment (P3.188)
Abstract
OBJECTIVE: To evaluate the effects of daclizumab high-yield process (DAC-HYP) on the volume of T1 hypointense lesions over 2 years in patients with relapsing-remitting MS who participated in the SELECT and SELECTION studies.
BACKGROUND: T1 hypointense lesions (ie, black holes) are a measure of tissue destruction from MS lesions that may predict long-term disability progression.
DESIGN/METHODS:
The volume of non-enhancing T1 black holes (T1-BHs) on cranial MRI was quantified at baseline, year 1 and year 2 in subjects (n=517) who participated in both the SELECT trial and its extension. In this exploratory analysis, changes in the volume of T1-BHs between DAC-HYP and placebo subjects at the end of year 1 were assessed using an analysis of covariance model on ranked data, adjusting for the baseline volume of T1-BHs.
RESULTS: After 1 year of treatment on DAC-HYP, subjects had a mean 15% decrease from baseline in volume of T1-BHs as compared to a 16% increase from baseline in the placebo-treated subjects ( p 3 vs 17.18 mm 3 ) and the DAC-HYP 300-mg dose group (44.9mm 3 vs 21.4mm 3 ). In comparison, among subjects entering the SELECT extension study, the mean volume of new T1-BHs during 1 year of placebo use was 231 mm 3 .
CONCLUSIONS:
Consistent with long-term protection against destructive MS lesions, DAC-HYP treatment resulted in a progressive reduction in the volume of T1-BHs over 2 years of treatment.
Study Supported by: Biogen Idec and AbbVie Biotherapeutics. Disclosure: Dr.…
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