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DACLIZUMAB HYP IN MULTIPLE SCLEROSIS: 3-YEAR RESULTS FROM SELECTED
  1. Ernst-Wilhelm Radue1,
  2. Gavin Giovannoni2,
  3. Ralf Gold3,
  4. Krzysztof Selmaj4,
  5. Eva Havrdova5,
  6. Dusan Stefoski6,
  7. Till Sprenger1,7,
  8. Xavier Montalban8,
  9. Kathy Riester9,
  10. Gulden Ozen9
  1. 1 University Hospital Basel, Switzerland
  2. 2 Queen Mary University of London
  3. 3 St. Josef-Hospital/Ruhr-University, Bochum, Germany
  4. 4 Medical University of Lodz, Poland
  5. 5 Charles University in Prague, Czech Republic
  6. 6 Rush University Medical Center, Chicago, IL, USA
  7. 7 DKD Helios Klinik, Wiesbaden, Germany
  8. 8 Hospital Vall d'Hebron University, Barcelona, Spain
  9. 9 Biogen, Cambridge, MA, USA

Abstract

Background In SELECTION, an extension study of SELECT evaluating the efficacy/safety of daclizumab high-yield process (DAC HYP) versus placebo, efficacy of DAC HYP in reducing clinical/radiological disease activity in relapsing-remitting multiple sclerosis (RRMS) patients demonstrated in SELECT was confirmed over 1–2 years.

Methods SELECTED is an ongoing, 6-year, single-arm, open-label study evaluating the efficacy/safety of 150 mg subcutaneous DAC HYP every 4 weeks in patients who completed SELECTION. An interim analysis was performed in January 2014, for patients with ≥3 years' continuous DAC HYP treatment.

Results Overall, 410 (90%) patients from SELECTION enrolled in SELECTED and 94 had been continuously treated at the time of the data-cut. Adjusted annualized relapse rate was 0.089 (95% confidence interval [CI]: 0.033–0.244) for weeks 96–120 and 0.047 (95% CI: 0.012–0.187) for weeks 120–144. In year 3, the adjusted mean number of new/newly enlarging T2 hyperintense lesions was 0.56 (95% CI: 0.24–1.32). Brain atrophy rate was reduced in year 3 from years 1–2 (mean annualized change: −0.3%). The safety profile in year 3 was similar to that observed in years 1–2.

Conclusions Efficacy of DAC HYP was sustained over 3 years in RRMS patients, supporting long-term maintenance therapy with DAC HYP.

Sponsors: Biogen, AbbVie Biotherapeutics.

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