Daclizumab HYP Reduces the Evolution of New Gadolinium-Enhancing Lesions to T1-Black Holes: Results from the SELECT Study (P07.094)

OBJECTIVE: To evaluate the effect of daclizumab high-yield process (DAC HYP) on the likelihood of acute gadolinium-enhancing (Gd+) lesions evolving to T1 black holes in patients with relapsing-remitting multiple sclerosis (RRMS). BACKGROUND: DAC HYP significantly reduced the number of new Gd+ lesions in patients with RRMS versus placebo in the SELECT study. 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: 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: 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. Supported by: Biogen Idec and Abbott Biotherapeutics. Disclosure: Dr. Radue has received personal compensation for activities with AIM, Biogen Idec, and Novartis as a consultant. Dr. Radue has received research support from Actelion, Bayer Pharmaceuticals Corporation, Biogen Idec, Merck Serono, and Novartis. Dr. Gold has received personal compensation for activities with Bayer HealthCare, Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience. Dr. Gold has received personal compensation in an editorial capacity for Therapeutic Advances in Neurological Disorders. Dr. Gold has received a license fee from Biogen Idec. Dr. Gold has received research support from Bayer HealthCare, Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience. Dr. Giovannoni has received personal compensation for activities with Merck Serono, Biogen Idec, Vertex Pharmaceuticals, Bayer Schering Pharma, Pfizer Inc, Teva Pharmaceutical Industries Ltd, and Sanofi. Dr. Giovannoni has received research support from Biogen Idec, Merck Serono, Novartis, and Ironwood. Dr. Stefoski has received personal compensation for activities with Biogen Idec, Acorda Therapeutics, Serono, Teva Neuroscience, EMD Serono, and Elan Corporation. Dr. Stefoski has received royalty payments from Acorda Therapeutics. Dr. Stefoski has received research support from Biogen Idec, Novartis, Serono, and Pfizer Inc. Dr. Selmaj has received personal compensation for activities with Biogen Idec, Genzyme, Ono Pharmaceutical, Novartis, Bayer, Hoffmann LaRoche, Merck, Serono and Synthon. Dr. You has received personal compensation for activities with Biogen Idec. Dr. Elkins has received personal compensation for activities with Biogen Idec as an employee. Dr. Elkins holds stock and/or stock options in Biogen Idec.

• Publication year

  2013

• Venue

  Neurology

• Publication date

  2013-02-12

• Fields of study

  Medicine

• Identifiers
  DOI 10.1212/wnl.80.7_supplement.p07.094
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar

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• No concepts are published for this paper.

• No references are available for this paper.

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