Abstract: EP1835
Type: ePoster
Abstract Category: Therapy - symptomatic - 34 Quality of life
Background: In DECIDE, patients with relapsing MS (RMS) treated with daclizumab beta (DAC BETA) 150mg every 4 weeks reported significantly greater mean improvements from baseline (BL) to Week 96 on the Multiple Sclerosis Impact Scale physical subscale (MSIS-29 PHYS; P< 0.001), the EQ-5D visual analogue scale (VAS; P< 0.001), and the EQ-5D health utility index (HUI; P=0.005) vs intramuscular (IM) interferon (IFN) beta-1a 30mcg once weekly.
Objective: Examine post hoc the effects of DAC BETA vs IM IFN beta-1a on patient-reported outcomes (PROs) in subgroups based on BL characteristics in DECIDE.
Methods: The MSIS-29 PHYS and the EQ-5D (VAS and HUI) were assessed at BL and then every 24 weeks. Subgroups included: sex (male, female); age (≤35y, >35y); time since diagnosis (< 3y, ≥3 to < 10y, ≥10y); relapses in prior year (≤1, ≥2); EDSS (< 3.5, ≥3.5); Gd+ lesions (absent, present); T2 lesion volume (< median, ≥median); prior disease-modifying therapy (DMT) (yes, no); disease activity (less active, highly active [≥2 relapses in year prior to randomization and ≥1 Gd+ lesion at baseline MRI]). Analyses were based on ANCOVA, adjusted for relevant BL covariates.
Results: Across all subgroups, the DAC BETA group demonstrated greater mean improvement, or less worsening, from BL to Week 96 in MSIS-29 PHYS score vs IM IFN beta-1a; treatment differences were significant (P< 0.05) for: female, age ≤35y, ≥2 relapses in prior year, EDSS< 3.5, Gd+ lesions present, T2 lesion volume ≥median, no prior DMT use, time since diagnosis (< 3y, ≥10y), less and highly active disease activity. At Week 96, vs IM IFN beta-1a, the DAC BETA group also showed greater mean improvement from BL on the EQ-5D VAS (differences significant for: female, male, age ≤35 y, time since diagnosis (< 3y), ≥2 relapses in prior year, EDSS < 3.5, Gd+ lesions present and absent, T2 lesion volume ≥median, no prior DMT use, less and highly active disease activity) and the EQ-5D HUI (differences significant for: female, age >35y, time since diagnosis (< 3y), ≤1 relapses in prior year, EDSS< 3.5, Gd+ lesions present, T2 lesion volume ≥median, no prior DMT use, less and highly active disease activity).
Conclusions: DAC BETA demonstrated improvements on PROs vs IM IFN beta-1a at Week 96 across all key subgroups. These effects were observed across all PROs for patients with lower baseline disability (EDSS< 3.5) and less time since diagnosis, providing further evidence of the benefits of early treatment on PROs.
Disclosure:
E. Havrdova: honoraria/research support from Actelion, Biogen, Celgene, Genzyme, Merck Serono, Novartis, Roche and Teva; advisory boards for Actelion, Biogen, Celgene, Genzyme, Merck Serono, Novartis and Roche; supported by the Czech Ministry of Education research project PROGRES Q27/LF1;
B. Turner: honoraria/clinical grants from Biogen, Genzyme, Merck Serono, Novartis, and Teva; and been a member of advisory boards for Biogen, Genzyme, Novartis, and Roche.
X. Ye: Employee of and holds stock/stock options in AbbVie Inc.
K. Riester, G. Giannattasio, C. Wakeford: 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: EP1835
Type: ePoster
Abstract Category: Therapy - symptomatic - 34 Quality of life
Background: In DECIDE, patients with relapsing MS (RMS) treated with daclizumab beta (DAC BETA) 150mg every 4 weeks reported significantly greater mean improvements from baseline (BL) to Week 96 on the Multiple Sclerosis Impact Scale physical subscale (MSIS-29 PHYS; P< 0.001), the EQ-5D visual analogue scale (VAS; P< 0.001), and the EQ-5D health utility index (HUI; P=0.005) vs intramuscular (IM) interferon (IFN) beta-1a 30mcg once weekly.
Objective: Examine post hoc the effects of DAC BETA vs IM IFN beta-1a on patient-reported outcomes (PROs) in subgroups based on BL characteristics in DECIDE.
Methods: The MSIS-29 PHYS and the EQ-5D (VAS and HUI) were assessed at BL and then every 24 weeks. Subgroups included: sex (male, female); age (≤35y, >35y); time since diagnosis (< 3y, ≥3 to < 10y, ≥10y); relapses in prior year (≤1, ≥2); EDSS (< 3.5, ≥3.5); Gd+ lesions (absent, present); T2 lesion volume (< median, ≥median); prior disease-modifying therapy (DMT) (yes, no); disease activity (less active, highly active [≥2 relapses in year prior to randomization and ≥1 Gd+ lesion at baseline MRI]). Analyses were based on ANCOVA, adjusted for relevant BL covariates.
Results: Across all subgroups, the DAC BETA group demonstrated greater mean improvement, or less worsening, from BL to Week 96 in MSIS-29 PHYS score vs IM IFN beta-1a; treatment differences were significant (P< 0.05) for: female, age ≤35y, ≥2 relapses in prior year, EDSS< 3.5, Gd+ lesions present, T2 lesion volume ≥median, no prior DMT use, time since diagnosis (< 3y, ≥10y), less and highly active disease activity. At Week 96, vs IM IFN beta-1a, the DAC BETA group also showed greater mean improvement from BL on the EQ-5D VAS (differences significant for: female, male, age ≤35 y, time since diagnosis (< 3y), ≥2 relapses in prior year, EDSS < 3.5, Gd+ lesions present and absent, T2 lesion volume ≥median, no prior DMT use, less and highly active disease activity) and the EQ-5D HUI (differences significant for: female, age >35y, time since diagnosis (< 3y), ≤1 relapses in prior year, EDSS< 3.5, Gd+ lesions present, T2 lesion volume ≥median, no prior DMT use, less and highly active disease activity).
Conclusions: DAC BETA demonstrated improvements on PROs vs IM IFN beta-1a at Week 96 across all key subgroups. These effects were observed across all PROs for patients with lower baseline disability (EDSS< 3.5) and less time since diagnosis, providing further evidence of the benefits of early treatment on PROs.
Disclosure:
E. Havrdova: honoraria/research support from Actelion, Biogen, Celgene, Genzyme, Merck Serono, Novartis, Roche and Teva; advisory boards for Actelion, Biogen, Celgene, Genzyme, Merck Serono, Novartis and Roche; supported by the Czech Ministry of Education research project PROGRES Q27/LF1;
B. Turner: honoraria/clinical grants from Biogen, Genzyme, Merck Serono, Novartis, and Teva; and been a member of advisory boards for Biogen, Genzyme, Novartis, and Roche.
X. Ye: Employee of and holds stock/stock options in AbbVie Inc.
K. Riester, G. Giannattasio, C. Wakeford: 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.