Abstract: Long-Term Efficacy and Safety of Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis: Results from the SELECTED Extension Study (2015 CMSC Annual Meeting)

DX30
Long-Term Efficacy and Safety of Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis: Results from the SELECTED Extension Study

Friday, May 29, 2015

Griffin Hall

Ralf Gold, MD , St Josef Hospital, Ruhr University Bochum, Bochum, Germany

Gavin Giovannoni, MBBCh, PhD , Queen Mary University London, Barts and The London School of Medicine, London, United Kingdom

Krzysztof W Selmaj, MD, PhD , Department of Neurology, Medical Academy of Lodz, Lodz, Poland

Eva Havrdova, MD, PhD , Department of Neurology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic

Ernst-Wilhelm Radue, MD , Medical Image Analysis Center, University Hospital Basel, Basel, Switzerland

Till Sprenger, MD , Medical Image Analysis Center, University Hospital Basel, Basel, Switzerland

Dusan Stefoski, MD , Rush University Medical Center, Chicago, IL

Xavier Montalbán, MD , Hospital Universitari Vall d’Hebron, Barcelona, Spain

Yaoshi Wu, MS , Biogen Idec, Cambridge, MA

Steven J Greenberg, MD , AbbVie Biotherapeutics Inc., Redwood City, CA

Gulden Ozen, MD, PhD, MS , Biogen Idec, Cambridge, MA

Mark Beatty, MD , Biogen Idec, Cambridge, MA

Jacob Elkins, MD , Biogen Idec, Cambridge, MA

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Background: Daclizumab high-yield process (DAC HYP) is a monoclonal antibody against CD25 that modulates IL-2 signaling. Its safety and efficacy over 2 years of treatment has previously been reported in the SELECTION trial.

Objectives: To evaluate the long-term safety and efficacy of DAC HYP 150mg subcutaneous (SC) every 4 weeks in patients with RRMS who previously completed up to 2 years’ treatment in SELECTION.

Methods: An interim analysis for patients who received continuous DAC HYP 150mg treatment was performed on January 20, 2014 (data cut-off date). Safety was evaluated for all patients enrolled. Descriptive statistics are reported.

Results: The SELECTED study enrolled 90% (N=410) of patients who completed SELECTION. In a subgroup of 94 patients continuously treated with DAC HYP 150mg for 3 years, the adjusted annualized relapse rate (95% CI) analyzed at 6-month intervals was 0.089 (0.033, 0.244) for Weeks >96-120 and 0.047 (0.012, 0.187) for Weeks >120-144. In Year 3, the adjusted mean (95% CI) number of new or newly enlarging T2 hyperintense lesions was 0.56 (0.24, 1.32) and the mean (median) annualized change in brain volume was -0.3% (-0.3%). In the overall safety analysis (N=410), median treatment time was 25 months (range 0-45; 854 patient-years). Adverse events (AEs) were reported in 76% of patients, serious AEs excluding MS relapse in 16%, treatment discontinuation due to AEs in 12%, study withdrawal due to AEs in 11%. AEs were mainly mild to moderate in severity and the most common AEs (≥10%) were MS relapse (22%), nasopharyngitis (12%), and upper respiratory tract infection (12%). Most commonly reported SAEs (in ≥3 patients) included MS relapse (11%) and ulcerative colitis, increased hepatic enzyme, pneumonia, and urinary tract infection (<1% each). The incidence of AEs, SAEs, and treatment-related study discontinuations did not increase over time and no deaths were reported.

Conclusions: The efficacy of daclizumab HYP on clinical and radiological outcomes was sustained over 3 years. The safety profile of DAC HYP was stable with extended duration of therapy into the third year of treatment in SELECTED.

DX30 Long-Term Efficacy and Safety of Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis: Results from the SELECTED Extension Study

DX30
Long-Term Efficacy and Safety of Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis: Results from the SELECTED Extension Study