Abstract Details

Title Daclizumab HYP Reduces the Evolution of New Gadolinium-Enhancing Lesions to T1-Black Holes: Results from the SELECT Study

Topic MS and Related Diseases

Presentation(s) P07 - (-)

Poster/Presentation
Number 094

Objective

Background BACKGROUND: DAC HYP significantly reduced the number of new Gd+ lesions in patients with RRMS versus placebo in the SELECT study.

Design/Methods DESIGN/METHODS: SELECT was a 52-week, randomized, double-blind, placebo-controlled, study of subcutaneous 150mg or 300mg DAC HYP every 4 weeks versus placebo. MRI scans were evaluated for the number and percentage of new Gd+ lesions from Week 4 to Week 20 (MRI intensive cohort) and at Week 24 (all patients) that evolved to T1 black holes at Week 52. A negative binomial regression model adjusting for baseline number of T2 lesions was used to evaluate the treatment effects on T1 black holes for DAC HYP (150mg and 300mg combined) versus placebo.

Results RESULTS: MRI scans from 272 patients that had new Gd+ lesions between Weeks 4-24 were evaluated. DAC HYP reduced the proportion of new Gd+ lesions at Week 24 that evolved to T1 black holes at Week 52 versus placebo (27.4% DAC HYP vs. 37.5% placebo; rate ratio [RR]: 0.42 [95% CI, 0.23-0.77; P=0.005]). Similarly, in the MRI intensive cohort, DAC HYP reduced the proportion of new Gd+ lesions from Weeks 4 to 20 that evolved to T1 black holes at Week 24 (29.9% DAC HYP vs. 31.7% placebo; RR: 0.60 [95% CI, 0.40-0.90; P=0.013]) and at Week 52 (15.8% DAC HYP vs. 19.0% placebo; RR: 0.54 [95% CI, 0.33-0.88; P=0.014]) versus placebo.

Conclusions CONCLUSIONS: In addition to reducing the number of new Gd+ lesions, DAC HYP reduced the likelihood that new Gd+ lesions would result in tissue destruction as measured by the formation of T1 black holes defined at least 6 months after the initial lesion formation.

Authors/Disclosures
Ernst-Wilhelm Radue, MD (Medical Image Analysis Center) PRESENTER	Dr. Radue has nothing to disclose.
Ralf Gold, MD (Neurologische Universitaetsklinik)	Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen . Dr. Gold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer Vital. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai Pharamaceuticals. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for SAGE Publishers. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Novartis. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Biogen. The institution of Dr. Gold has received research support from Novartis. The institution of Dr. Gold has received research support from Biogen.
Gavin Giovannoni, MD (QMUL)	Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck KGaA. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche-Genentech. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moderna. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Astoria Biologica. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zenas. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Medscape.
Shifang Liu	No disclosure on file
Dusan Stefoski, MD, FAAN	No disclosure on file
	No disclosure on file
Xiaojun You, PhD (Biogen Idec Inc.)	No disclosure on file
Jacob S. Elkins, MD	No disclosure on file
Bruce L. Miller, MD, FAAN (University of California, San Francisco)	Dr. Miller has nothing to disclose.

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