Abstract Details

Title Proportion of Disease-Activity Free Patients with Relapsing-Remitting Multiple Sclerosis Following 1 Year of Treatment with Daclizumab High-Yield Process in the SELECT Study

Topic MS and Related Diseases

Presentation(s) P07 - (-)

Poster/Presentation
Number 105

Objective

Background BACKGROUND: The development of targeted biologic therapies has made remission of disease activity a realistic goal. DAC HYP is a humanized monoclonal antibody that binds the ?-subunit (CD25) of the interleukin-2 receptor (IL-2R) and inhibits high-affinity IL-2R signalling.

Design/Methods DESIGN/METHODS: SELECT was a randomized, double-blind, multicenter study of DAC HYP 150mg, DAC HYP 300mg, or placebo administered subcutaneously every 4 weeks for 52 weeks in relapsing-remitting MS (RRMS) patients. Efficacy outcomes were similar between doses in the trial, so the dose groups were pooled for this analysis. Disease-activity free was defined as completion of the study through Week 52 without relapses or confirmed 3-month disability progression, with no new or enlarging T2 hyperintense lesions and no new Gd+-enhancing lesions. The primary analysis was based on logistic regression controlling for baseline characteristics (age [?35 vs >35 years], Expanded Disability Status Scale (EDSS) [?2.5 vs >2.5], number of lesions, and number of relapses in previous year).

Results RESULTS: A greater proportion of DAC HYP-treated patients (n=404) versus placebo (n=196) were disease-activity free (39% vs. 11%, respectively; odds ratio [95% confidence interval], 6.18 [3.71-10.32]; P<0.0001). Furthermore, 81% of DAC HYP-treated patients were relapse-free compared with 65% of placebo-treated patients (P<0.0001) and 6% of DAC HYP-treated patients experienced disability progression versus 13% in the placebo group (P=0.015).There were no new or newly-enlarging T2-hyperintense lesions in 48% of DAC HYP-treated patients compared with 19% of placebo-treated patients (P<0.0001) and no new Gd+ lesions in 73% of DAC HYP-treated patients compared with 50% of patients in the placebo group (P<0.0001).

Conclusions CONCLUSIONS: DAC HYP treatment for 1 year resulted in a meaningful increase in the proportion of RRMS patients who were disease-activity free versus placebo.

Authors/Disclosures
Eva Havrdova, MD (Neurologicka Klinika 1 LF UK) PRESENTER	Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi.
Atul T. Patel	Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance. Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for IPSEN. Atul T. Patel has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/Abbvie. Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for IPSEN. The institution of Atul T. Patel has received research support from Abbvie. The institution of Atul T. Patel has received research support from IPSEN.
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.
Dusan Stefoski, MD, FAAN	No disclosure on file
Kimberly Umans	No disclosure on file
Steven J. Greenberg, MD (Steven J. Greenberg, M.D.)	No disclosure on file
Lahar R. Mehta, MD	Dr. Mehta has received personal compensation for serving as an employee of Amylyx Pharmaceuticals.
Jacob S. Elkins, MD	No disclosure on file

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