Daclizumab high‐yield process reduced the evolution of new gadolinium‐enhancing lesions to T1 black holes in patients with relapsing−remitting multiple sclerosis. (February 2016) - Radue, E.‐W.
Abstract : Background and purpose: In the SELECT study, treatment with daclizumab high‐yield process (DAC HYP) versus placebo reduced the frequency of gadolinium‐enhancing (Gd + ) lesions in patients with relapsing−remitting multiple sclerosis (RRMS). The objective of this post hoc analysis of SELECT was to evaluate the effect of DAC HYP on the evolution of new Gd + lesions to T1 hypointense lesions (T1 black holes). Methods: SELECT was a randomized double‐blind study of subcutaneous DAC HYP 150 or 300 mg or placebo every 4 weeks. Magnetic resonance imaging (MRI) scans were performed at baseline and weeks 24, 36 and 52 in all patients and monthly between weeks 4 and 20 in a subset of patients. MRI scans were evaluated for new Gd + lesions that evolved to T1 black holes at week 52. Data for the DAC HYP groups were pooled for analysis. Results: Daclizumab high‐yield process reduced the number of new Gd + lesions present at week 24 ( P = 0.005) or between weeks 4 and 20 ( P = 0.014) that evolved into T1 black holes at week 52 versus placebo. DAC HYP treatment also reduced the percentage of patients with Gd + lesions evolving to T1 black holes versus placebo. Conclusions: Treatment with DAC HYP reduced the evolution of Gd + lesions to T1 black holes versus placebo, suggesting that inflammatory lesions that evolved during DAC HYP treatment are less destructive than those evolving during placebo treatment.