Article Text

Download PDFPDF
  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


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.

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.