Contributions
Abstract: P731
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: EXTEND is an ongoing, multicentre, open-label safety/efficacy extension study of daclizumab beta (DAC BETA) in patients with relapsing multiple sclerosis who completed DECIDE or transitioned from SELECTED or OBSERVE.
Objectives: To evaluate the effects of DAC BETA on clinical and radiologic disease outcomes after up to 3 years of treatment in EXTEND in patients who completed DECIDE.
Methods: Patients who received DAC BETA or intramuscular (IM) interferon (IFN) beta-1a in DECIDE receive open-label treatment with DAC BETA 150mg subcutaneous every 4 weeks for up to 5 years in EXTEND. An interim efficacy analysis was conducted using data acquired through 9 September 2016. Annualised relapse rate (ARR) and MRI analyses included patients enrolled in EXTEND who had completed DECIDE (DECIDE-EXTEND intention-to-treat [ITT] population). 24-week confirmed disability progression (CDP) was analysed in the DECIDE ITT population in the combined DECIDE/EXTEND treatment period.
Results: 1516 patients received ≥1 dose of DAC BETA in DECIDE or EXTEND (exposure, 4637 patient-years; median [range], 34.0 [1-83] doses). 1203/1841 patients enrolled in EXTEND from DECIDE: 606 patients continuing DAC BETA treatment (DAC BETA/DAC BETA) and 597 patients who switched from IM IFN beta-1a to DAC BETA (IFN/DAC BETA). At the end of DECIDE, the adjusted ARR (95%CI) was 0.195 (0.169-0.225) in DAC BETA/DAC BETA versus 0.317 (0.280-0.360) in IFN/DAC BETA DECIDE-EXTEND ITT patients. In EXTEND, the adjusted ARR (95%CI) in DAC/DAC and IFN/DAC groups was 0.162 (0.128-0.205) and 0.151 (0.118-0.193) for Weeks 1-48, 0.140 (0.107-0.184) and 0.158 (0.122-0.206) for Weeks 49-96, and 0.173 (0.130-0.229) and 0.171 (0.128-0.229) for Weeks 97-144. At Week 240 in the combined DECIDE/EXTEND study period, an estimated 20.6% of DAC BETA/DAC BETA (n=919) versus 26.3% of IFN/DAC BETA (n=922) patients had 24-week CDP (HR: 0.752; 95%CI: 0.600-0.942; P=0.013). During the EXTEND treatment period, median annualised percentage brain volume change was −0.346 and −0.416 between EXTEND baseline and Week 48 and −0.250 and −0.370 between EXTEND baseline and Week 96 in the DAC BETA/DAC BETA and IFN/DAC BETA groups, respectively.
Conclusions: In EXTEND, effects on clinical outcomes and brain volume change were maintained during prolonged DAC BETA treatment (up to 6 years) and patients who switched from IFN in DECIDE to DAC BETA in EXTEND showed improved outcomes over up to 3 years of DAC BETA treatment.
Disclosure:
L. Kappos: institution has received in the last 3 years and used exclusively for research support: steering committee/consulting fees from Actelion, Addex, Bayer HealthCare, Biogen, Biotica, Genzyme, Lilly, Merck, Mitsubishi, Novartis, Ono, Pfizer, Receptos, Sanofi-Aventis, Santhera, Siemens, Teva, UCB, and Xenoport; speaker fees from Bayer HealthCare, Biogen, Merck, Novartis, Sanofi-Aventis, and Teva; support of educational activities from Bayer HealthCare, Biogen, CSL Behring, Genzyme, Merck, Novartis, Sanofi-Aventis, and Teva; license fees for Neurostatus products; grants from Bayer HealthCare, Biogen, the European Union, Merck, Novartis, Roche, Roche Research Foundations, the Swiss Multiple Sclerosis Society, and the Swiss National Research Foundation.
S. Cohan: advisory boards for Biogen, Genzyme, Mallinckrodt, and Novartis; speaker bureaus for Acorda, Biogen, Genentech, Genzyme, and Novartis; research support from Biogen, Genentech, Genzyme, Mallinckrodt, MedDay, Novartis, Opexa, and Roche.
D. L. Arnold: honoraria from Adelphi, Biogen, Genentech, Genzyme, MedDay, Novartis Pharma AG, Pfizer, Receptos, Roche, and Sanofi-Aventis; research support from Biogen and Novartis; employee of and hold stock/stock options in NeuroRx Inc.
R. R. Robinson: employee of and hold stock/stock options in AbbVie Inc.
B. Parks, H. Chen, S. Fam: employees of and hold stock/stock options in Biogen.
Supported by: Biogen and AbbVie Inc. Writing and editorial support for the preparation of this abstract was provided by Excel Scientific Solutions (Southport, CT, USA): funding was provided by Biogen and AbbVie Inc.
Abstract: P731
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: EXTEND is an ongoing, multicentre, open-label safety/efficacy extension study of daclizumab beta (DAC BETA) in patients with relapsing multiple sclerosis who completed DECIDE or transitioned from SELECTED or OBSERVE.
Objectives: To evaluate the effects of DAC BETA on clinical and radiologic disease outcomes after up to 3 years of treatment in EXTEND in patients who completed DECIDE.
Methods: Patients who received DAC BETA or intramuscular (IM) interferon (IFN) beta-1a in DECIDE receive open-label treatment with DAC BETA 150mg subcutaneous every 4 weeks for up to 5 years in EXTEND. An interim efficacy analysis was conducted using data acquired through 9 September 2016. Annualised relapse rate (ARR) and MRI analyses included patients enrolled in EXTEND who had completed DECIDE (DECIDE-EXTEND intention-to-treat [ITT] population). 24-week confirmed disability progression (CDP) was analysed in the DECIDE ITT population in the combined DECIDE/EXTEND treatment period.
Results: 1516 patients received ≥1 dose of DAC BETA in DECIDE or EXTEND (exposure, 4637 patient-years; median [range], 34.0 [1-83] doses). 1203/1841 patients enrolled in EXTEND from DECIDE: 606 patients continuing DAC BETA treatment (DAC BETA/DAC BETA) and 597 patients who switched from IM IFN beta-1a to DAC BETA (IFN/DAC BETA). At the end of DECIDE, the adjusted ARR (95%CI) was 0.195 (0.169-0.225) in DAC BETA/DAC BETA versus 0.317 (0.280-0.360) in IFN/DAC BETA DECIDE-EXTEND ITT patients. In EXTEND, the adjusted ARR (95%CI) in DAC/DAC and IFN/DAC groups was 0.162 (0.128-0.205) and 0.151 (0.118-0.193) for Weeks 1-48, 0.140 (0.107-0.184) and 0.158 (0.122-0.206) for Weeks 49-96, and 0.173 (0.130-0.229) and 0.171 (0.128-0.229) for Weeks 97-144. At Week 240 in the combined DECIDE/EXTEND study period, an estimated 20.6% of DAC BETA/DAC BETA (n=919) versus 26.3% of IFN/DAC BETA (n=922) patients had 24-week CDP (HR: 0.752; 95%CI: 0.600-0.942; P=0.013). During the EXTEND treatment period, median annualised percentage brain volume change was −0.346 and −0.416 between EXTEND baseline and Week 48 and −0.250 and −0.370 between EXTEND baseline and Week 96 in the DAC BETA/DAC BETA and IFN/DAC BETA groups, respectively.
Conclusions: In EXTEND, effects on clinical outcomes and brain volume change were maintained during prolonged DAC BETA treatment (up to 6 years) and patients who switched from IFN in DECIDE to DAC BETA in EXTEND showed improved outcomes over up to 3 years of DAC BETA treatment.
Disclosure:
L. Kappos: institution has received in the last 3 years and used exclusively for research support: steering committee/consulting fees from Actelion, Addex, Bayer HealthCare, Biogen, Biotica, Genzyme, Lilly, Merck, Mitsubishi, Novartis, Ono, Pfizer, Receptos, Sanofi-Aventis, Santhera, Siemens, Teva, UCB, and Xenoport; speaker fees from Bayer HealthCare, Biogen, Merck, Novartis, Sanofi-Aventis, and Teva; support of educational activities from Bayer HealthCare, Biogen, CSL Behring, Genzyme, Merck, Novartis, Sanofi-Aventis, and Teva; license fees for Neurostatus products; grants from Bayer HealthCare, Biogen, the European Union, Merck, Novartis, Roche, Roche Research Foundations, the Swiss Multiple Sclerosis Society, and the Swiss National Research Foundation.
S. Cohan: advisory boards for Biogen, Genzyme, Mallinckrodt, and Novartis; speaker bureaus for Acorda, Biogen, Genentech, Genzyme, and Novartis; research support from Biogen, Genentech, Genzyme, Mallinckrodt, MedDay, Novartis, Opexa, and Roche.
D. L. Arnold: honoraria from Adelphi, Biogen, Genentech, Genzyme, MedDay, Novartis Pharma AG, Pfizer, Receptos, Roche, and Sanofi-Aventis; research support from Biogen and Novartis; employee of and hold stock/stock options in NeuroRx Inc.
R. R. Robinson: employee of and hold stock/stock options in AbbVie Inc.
B. Parks, H. Chen, S. Fam: employees of and hold stock/stock options in Biogen.
Supported by: Biogen and AbbVie Inc. Writing and editorial support for the preparation of this abstract was provided by Excel Scientific Solutions (Southport, CT, USA): funding was provided by Biogen and AbbVie Inc.