Abstract Details

Title Efficacy of Daclizumab HYP Treatment in Patients with Highly Active Relapsing-Remitting Multiple Sclerosis: Results from the SELECT Study

Topic MS and Related Diseases

Presentation(s) P07 - (-)

Poster/Presentation
Number 113

Objective

Background BACKGROUND: RRMS patients with frequent relapses and higher MRI lesion burden are at greater risk for disease progression. Daclizumab is a humanized monoclonal antibody specific for the CD25-subunit of the IL-2 receptor.

Design/Methods DESIGN/METHODS: SELECT was a randomized, double-blind, placebo-controlled study of DAC HYP 150mg, 300mg or placebo administered subcutaneously every 4 weeks for 52 weeks in RRMS patients. Reductions in the annualized relapse rate [ARR] and number of new/enlarging T2-hyperintense lesions were estimated by negative binomial regression. Estimated time to progression and proportion of patients with progression was calculated by a Cox proportional hazards model. A proportional odds model estimated the number of new Gd+ lesions at Week 52 (adjusted for treatment and baseline). Interaction P-values were derived in separate models that also adjusted for baseline, treatment, and MS disease activity (HA vs. non-highly active [nHA]) by treatment variable interaction. HA RRMS was defined as ?2 relapses in the year before randomization and ?1 gadolinium-enhancing (Gd+) lesion at baseline) at entry to the SELECT trial.

Results RESULTS: Overall 15% of patients (placebo, n=30; DAC HYP, n=58) met the criteria for HA RRMS and 85% (placebo, n=165; DAC HYP, n=341) for nHA RRMS. DAC HYP treatment resulted in similar reductions versus placebo in ARR (HA: 50.5%, P=0.0394 vs. nHA: 51.4%, P<0.0001; Interaction P=0.8228), the mean number of new/enlarging T2 lesions at Week 52 (HA: 75.9%, P<0.0001 vs. nHA: 72.6%, P<0.0001; Interaction P=0.1794), the risk of higher Gd+ lesion activity (HA: 89%, P<0.0001 vs. nHA: 86%, P<0.0001; Interaction P=0.4621), and in 3-month sustained disability progression (HA: 88%, P=0.0574 vs. nHA: 46%, P=0.0383; Interaction P=0.2163).

Conclusions CONCLUSIONS: Effects of DAC HYP were similar in patients with HA RRMS compared with patients with nHA RRMS at baseline.

Authors/Disclosures
Lahar R. Mehta, MD PRESENTER	Dr. Mehta has received personal compensation for serving as an employee of Amylyx Pharmaceuticals.
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.
Ernst-Wilhelm Radue, MD (Medical Image Analysis Center)	Dr. Radue has nothing to disclose.
Eva Havrdova, MD (Neurologicka Klinika 1 LF UK)	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.
Katherine A. Riester, MPH (Biogen)	No disclosure on file
Steven J. Greenberg, MD (Steven J. Greenberg, M.D.)	No disclosure on file
Jacob S. Elkins, MD	No disclosure on file
Allan G. Kermode, MD, MBBS, FRACP (SJOG Clinic, Suite 314)	Dr. Kermode has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Kermode has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche.

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