Abstract: P695
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: In DECIDE, significantly more patients treated with daclizumab beta (DAC BETA) 150mg achieved no evidence of disease activity (NEDA) vs intramuscular (IM) interferon (IFN) beta-1a 30mcg over 2 years (baseline [BL] to Week 96; P< 0.0001). Evidence of DAC BETA benefits was more pronounced between Weeks 24-96.
Objective: Examine the influence of BL characteristics on achievement of NEDA in patients receiving DAC BETA vs IM IFN beta-1a in DECIDE.
Methods: NEDA (defined as no relapses, no 12-week confirmed disability progression, no new/enlarging T2 lesions, and no Gd+ lesions) was examined from BL to Week 96 and from Week 24 to 96. Analyses were based on logistic regression models adjusted for relevant BL characteristics. Also, a GUIDE machine learning algorithm for constructing classification trees was used for predicting NEDA from BL patient characteristics.
Results: Significantly more DAC BETA vs IFN beta-1a patients achieved NEDA across the majority of subgroups from BL to Week 96. Across all subgroups, percentages (odds ratio) of patients achieving NEDA were consistently higher for DAC BETA vs IM IFN beta-1a-treated patients: Age: ≤35y, 19.0 vs 6.5 (3.48), >35y, 30.2 vs 21.4 (1.60); male, 25.6 vs 13.6 (2.36), female, 24.1 vs 14.4 (1.93); Time since diagnosis: < 3y, 23.6 vs 13.4 (2.04), ≥3 to < 10y, 23.4 vs 13.9 (2.17), ≥10y, 30.8 vs 18.0 (2.02); relapses in previous year: ≤1, 27.4 vs 14.5 (2.27), >1, 21.2 vs 13.8 (1.76); EDSS, < 3.5, 25.3 vs 13.3 (2.29), ≥3.5, 22.6 vs 16.1 (1.58); T2 lesion volume, < median, 30.0 vs 18.4 (1.90), ≥median, 19.0 vs 10.6 (2.15); Gd+ lesions: absent, 36.5 vs 21.2 (2.28), present, 10.2 vs 6.5 (1.61); prior IFN beta: yes, 20.7 vs 12.6 (2.09), no, 26.6 vs 14.9 (2.07); prior DMT: yes, 21.3 vs 12.7 (2.10), no, 26.9 vs 15.2 (2.06); disease activity: less active, 29.2 vs 17.1 (2.07), highly active (≥2 relapses in prior year and ≥1 Gd+ lesion at BL), 7.1 vs 4.7 (1.59). From BL to Week 96, treatment comparisons were significant (P< 0.05) for all subgroups except: EDSS ≥3.5, Gd+ lesions present, highly active disease. For Weeks 24-96, more DAC BETA vs IM IFN beta-1a patients achieved NEDA, with higher ORs (2.17 to 4.23) and significant differences across all subgroups analysed.
Conclusion: DAC BETA demonstrated greater benefits on achievement of NEDA vs IM IFN beta-1a across clinically important subgroups. Higher odds of achieving NEDA were observed for lower EDSS and lower MRI burden at BL (also confirmed by GUIDE).
Disclosure:
G. Giovannoni: advisory boards for AbbVie Inc., Almirall, Atara Bio, Biogen, Canbex, Ironwood, Novartis, Merck, Merck Serono, Roche, Sanofi-Genzyme, Synthon, Teva and Vertex; speaker fees from AbbVie Inc., Biogen, Bayer HealthCare, Genzyme, Merck Serono, Sanofi-Aventis and Teva; co-editor in chief of Multiple Sclerosis and Related Disorders; research support unrelated to study from Biogen, Genzyme, Ironwood, Merck Serono and Novartis;
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
E. Havrdova: honoraria/research support from Bayer HealthCare, Biogen, Genzyme, Merck Serono, Novartis and Teva; advisory boards for Biogen, Genzyme, Merck Serono, Novartis and Teva; supported by the Czech Ministry of Education research project PRVOUK-P26/LF1/4;
B. Khatri: consulting/speaker fees from Avanir, Biogen, EMD Serono, Genzyme, Mallinckrodt, Novartis, Pfizer, and Teva.
L. Chiodo: an employee of and holds stock/stock options in AbbVie Inc.
O. Mokliatchouk, K. Riester, G. Giannattasio: 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: P695
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: In DECIDE, significantly more patients treated with daclizumab beta (DAC BETA) 150mg achieved no evidence of disease activity (NEDA) vs intramuscular (IM) interferon (IFN) beta-1a 30mcg over 2 years (baseline [BL] to Week 96; P< 0.0001). Evidence of DAC BETA benefits was more pronounced between Weeks 24-96.
Objective: Examine the influence of BL characteristics on achievement of NEDA in patients receiving DAC BETA vs IM IFN beta-1a in DECIDE.
Methods: NEDA (defined as no relapses, no 12-week confirmed disability progression, no new/enlarging T2 lesions, and no Gd+ lesions) was examined from BL to Week 96 and from Week 24 to 96. Analyses were based on logistic regression models adjusted for relevant BL characteristics. Also, a GUIDE machine learning algorithm for constructing classification trees was used for predicting NEDA from BL patient characteristics.
Results: Significantly more DAC BETA vs IFN beta-1a patients achieved NEDA across the majority of subgroups from BL to Week 96. Across all subgroups, percentages (odds ratio) of patients achieving NEDA were consistently higher for DAC BETA vs IM IFN beta-1a-treated patients: Age: ≤35y, 19.0 vs 6.5 (3.48), >35y, 30.2 vs 21.4 (1.60); male, 25.6 vs 13.6 (2.36), female, 24.1 vs 14.4 (1.93); Time since diagnosis: < 3y, 23.6 vs 13.4 (2.04), ≥3 to < 10y, 23.4 vs 13.9 (2.17), ≥10y, 30.8 vs 18.0 (2.02); relapses in previous year: ≤1, 27.4 vs 14.5 (2.27), >1, 21.2 vs 13.8 (1.76); EDSS, < 3.5, 25.3 vs 13.3 (2.29), ≥3.5, 22.6 vs 16.1 (1.58); T2 lesion volume, < median, 30.0 vs 18.4 (1.90), ≥median, 19.0 vs 10.6 (2.15); Gd+ lesions: absent, 36.5 vs 21.2 (2.28), present, 10.2 vs 6.5 (1.61); prior IFN beta: yes, 20.7 vs 12.6 (2.09), no, 26.6 vs 14.9 (2.07); prior DMT: yes, 21.3 vs 12.7 (2.10), no, 26.9 vs 15.2 (2.06); disease activity: less active, 29.2 vs 17.1 (2.07), highly active (≥2 relapses in prior year and ≥1 Gd+ lesion at BL), 7.1 vs 4.7 (1.59). From BL to Week 96, treatment comparisons were significant (P< 0.05) for all subgroups except: EDSS ≥3.5, Gd+ lesions present, highly active disease. For Weeks 24-96, more DAC BETA vs IM IFN beta-1a patients achieved NEDA, with higher ORs (2.17 to 4.23) and significant differences across all subgroups analysed.
Conclusion: DAC BETA demonstrated greater benefits on achievement of NEDA vs IM IFN beta-1a across clinically important subgroups. Higher odds of achieving NEDA were observed for lower EDSS and lower MRI burden at BL (also confirmed by GUIDE).
Disclosure:
G. Giovannoni: advisory boards for AbbVie Inc., Almirall, Atara Bio, Biogen, Canbex, Ironwood, Novartis, Merck, Merck Serono, Roche, Sanofi-Genzyme, Synthon, Teva and Vertex; speaker fees from AbbVie Inc., Biogen, Bayer HealthCare, Genzyme, Merck Serono, Sanofi-Aventis and Teva; co-editor in chief of Multiple Sclerosis and Related Disorders; research support unrelated to study from Biogen, Genzyme, Ironwood, Merck Serono and Novartis;
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
E. Havrdova: honoraria/research support from Bayer HealthCare, Biogen, Genzyme, Merck Serono, Novartis and Teva; advisory boards for Biogen, Genzyme, Merck Serono, Novartis and Teva; supported by the Czech Ministry of Education research project PRVOUK-P26/LF1/4;
B. Khatri: consulting/speaker fees from Avanir, Biogen, EMD Serono, Genzyme, Mallinckrodt, Novartis, Pfizer, and Teva.
L. Chiodo: an employee of and holds stock/stock options in AbbVie Inc.
O. Mokliatchouk, K. Riester, G. Giannattasio: 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.