Abstract: P664
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: In DECIDE, a significantly greater percentage of patients receiving daclizumab high-yield process (DAC HYP) 150 mg achieved no evidence of disease activity (NEDA) vs intramuscular (IM) interferon (IFN) beta-1a 30 mcg (24.6% vs 14.2%, odds ratio [OR; 95% CI], 2.059 [1.592-2.661]; P< .0001) from baseline to Week 96. Presence of residual disease activity from pre-treatment epoch emerging in the first months while a new therapy reaches full efficacy may impact evaluation of treatment effects on achievement of NEDA.
Objective: To separately examine post hoc the percentage of patients achieving NEDA in DECIDE in the first 6 months (baseline to Week 24) and the following 18 months (Weeks 24-96) of treatment.
Methods: NEDA was defined as the composite of no relapses, no 12-week confirmed disability progression (CDP), no new/enlarging T2 (NET2) lesions (vs start of time interval), and no gadolinium-enhancing (Gd+) lesions (at MRI scans performed after start of time interval). Analyses were based on logistic regression models adjusted for relevant baseline characteristics.
Results: From baseline to Week 24, a significantly greater percentage of DAC HYP vs IFN beta-1a patients achieved overall NEDA (41.5% vs 32.6%; OR [95%CI], 1.507 [1.232-1.842], P< .0001), clinical NEDA (no relapses, no 12-week CDP) (86.5% [795/919] vs 82.2% [758/922]; OR, 1.393 [1.075, 1.806]; P=.0121) and MRI NEDA (no NET2, no Gd+ lesions) (47.1% [412/875] vs 39.0% [330/847]; OR, 1.442 [1.183, 1.758]; P=.0003). For Weeks 24-96, a significantly greater percentage of DAC HYP vs IFN beta-1a patients achieved overall NEDA (44.7% [347/776] vs 22.4% [173/773]; OR, 2.960 [2.364-3.708]; P< .0001); clinical NEDA (77.6% [685/883] vs 64.3% [547/851]; OR, 1.959 [1.581, 2.428]; P< .0001) and MRI NEDA (59.0% [441/748] vs 35.2% [255/725]; OR, 2.925 [2.349, 3.643];
P< .0001). ORs for the majority of measures were notably higher for Weeks 24-96. In patients who were not NEDA from baseline to Week 24 but achieved NEDA during Weeks 24-96, 80.0% of IFN beta-1a and 79.6% of DAC HYP had MRI activity only from baseline to Week 24.
Conclusion: Superiority of DAC HYP vs IFN beta-1a on NEDA status was observed during the first 6 months of treatment in DECIDE and became even more evident during the following 18 months when treatments reached full efficacy and effects were less diluted by pre-treatment disease activity.
Disclosure:
Gavin Giovannoni: fees for participation in advisory boards for AbbVie Biotherapeutics Inc., Biogen, Canbex, Ironwood, Merck, Merck Serono, Novartis, Roche, Sanofi-Genzyme, Synthon, Teva and Vertex; has received speaker fees from AbbVie Biotherapeutics Inc., Bayer HealthCare, Biogen, Genzyme, Merck Serono, Sanofi-Aventis and Teva; is co-editor in chief of Multiple Sclerosis and Related Disorders; research support unrelated to study from Biogen, Genzyme, Ironwood, Merck Serono and Novartis;
Ludwig Kappos: institution (University Hospital Basel) received in the last 3 years and used exclusively for research support: steering committee/consulting fees for Actelion, Addex, Bayer HealthCare, Biogen, Biotica, Genzyme, Lilly, Merck, Mitsubishi, Novartis, Ono, Pfizer, Receptos, Sanofi-Aventis, Santhera, Siemens, Teva, UCB and Xenoport. Dr. Kappos has received 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, royalties from Neurostatus Systems GmbH; and 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;
Eva Havrdova: honoraria/research support from Biogen, Genzyme, Merck Serono, Novartis, Roche and Teva; and advisory boards for Actelion, Biogen, Genzyme, Novartis, Receptos and Teva; supported by the Czech Ministry of Education research project PRVOUK-P26/LF1/4;
Bhupendra O. Khatri: consultant/speaker for Avanir, Biogen, EMD Serono, Genzyme, Mallinckrodt (formerly Questcor), Novartis, Pfizer and Teva;
Susan A. Gauthier: honoraria from Genzyme and Genentech; and research support from Biogen, EMD Serono, Genzyme, Mallinckrodt, and Novartis;
Steven J Greenberg: employee of and holds stock/stock options in AbbVie Inc.;
Ping Wang and Giorgio Giannattasio: employees of and hold stock/stock options in Biogen.
Supported by: Biogen and AbbVie Biotherapeutics Inc.
Biogen and AbbVie Biotherapeutics Inc. provided funding for medical writing support in the development of this abstract. Rebecca Jarvis (Excel Scientific Solutions, Southport, CT) wrote the first draft of the abstract based on input from authors. Biogen and AbbVie Biotherapeutics Inc. reviewed and provided feedback on the abstract. The authors had full editorial control of the abstract, and provided their final approval of all content.
Abstract: P664
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: In DECIDE, a significantly greater percentage of patients receiving daclizumab high-yield process (DAC HYP) 150 mg achieved no evidence of disease activity (NEDA) vs intramuscular (IM) interferon (IFN) beta-1a 30 mcg (24.6% vs 14.2%, odds ratio [OR; 95% CI], 2.059 [1.592-2.661]; P< .0001) from baseline to Week 96. Presence of residual disease activity from pre-treatment epoch emerging in the first months while a new therapy reaches full efficacy may impact evaluation of treatment effects on achievement of NEDA.
Objective: To separately examine post hoc the percentage of patients achieving NEDA in DECIDE in the first 6 months (baseline to Week 24) and the following 18 months (Weeks 24-96) of treatment.
Methods: NEDA was defined as the composite of no relapses, no 12-week confirmed disability progression (CDP), no new/enlarging T2 (NET2) lesions (vs start of time interval), and no gadolinium-enhancing (Gd+) lesions (at MRI scans performed after start of time interval). Analyses were based on logistic regression models adjusted for relevant baseline characteristics.
Results: From baseline to Week 24, a significantly greater percentage of DAC HYP vs IFN beta-1a patients achieved overall NEDA (41.5% vs 32.6%; OR [95%CI], 1.507 [1.232-1.842], P< .0001), clinical NEDA (no relapses, no 12-week CDP) (86.5% [795/919] vs 82.2% [758/922]; OR, 1.393 [1.075, 1.806]; P=.0121) and MRI NEDA (no NET2, no Gd+ lesions) (47.1% [412/875] vs 39.0% [330/847]; OR, 1.442 [1.183, 1.758]; P=.0003). For Weeks 24-96, a significantly greater percentage of DAC HYP vs IFN beta-1a patients achieved overall NEDA (44.7% [347/776] vs 22.4% [173/773]; OR, 2.960 [2.364-3.708]; P< .0001); clinical NEDA (77.6% [685/883] vs 64.3% [547/851]; OR, 1.959 [1.581, 2.428]; P< .0001) and MRI NEDA (59.0% [441/748] vs 35.2% [255/725]; OR, 2.925 [2.349, 3.643];
P< .0001). ORs for the majority of measures were notably higher for Weeks 24-96. In patients who were not NEDA from baseline to Week 24 but achieved NEDA during Weeks 24-96, 80.0% of IFN beta-1a and 79.6% of DAC HYP had MRI activity only from baseline to Week 24.
Conclusion: Superiority of DAC HYP vs IFN beta-1a on NEDA status was observed during the first 6 months of treatment in DECIDE and became even more evident during the following 18 months when treatments reached full efficacy and effects were less diluted by pre-treatment disease activity.
Disclosure:
Gavin Giovannoni: fees for participation in advisory boards for AbbVie Biotherapeutics Inc., Biogen, Canbex, Ironwood, Merck, Merck Serono, Novartis, Roche, Sanofi-Genzyme, Synthon, Teva and Vertex; has received speaker fees from AbbVie Biotherapeutics Inc., Bayer HealthCare, Biogen, Genzyme, Merck Serono, Sanofi-Aventis and Teva; is co-editor in chief of Multiple Sclerosis and Related Disorders; research support unrelated to study from Biogen, Genzyme, Ironwood, Merck Serono and Novartis;
Ludwig Kappos: institution (University Hospital Basel) received in the last 3 years and used exclusively for research support: steering committee/consulting fees for Actelion, Addex, Bayer HealthCare, Biogen, Biotica, Genzyme, Lilly, Merck, Mitsubishi, Novartis, Ono, Pfizer, Receptos, Sanofi-Aventis, Santhera, Siemens, Teva, UCB and Xenoport. Dr. Kappos has received 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, royalties from Neurostatus Systems GmbH; and 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;
Eva Havrdova: honoraria/research support from Biogen, Genzyme, Merck Serono, Novartis, Roche and Teva; and advisory boards for Actelion, Biogen, Genzyme, Novartis, Receptos and Teva; supported by the Czech Ministry of Education research project PRVOUK-P26/LF1/4;
Bhupendra O. Khatri: consultant/speaker for Avanir, Biogen, EMD Serono, Genzyme, Mallinckrodt (formerly Questcor), Novartis, Pfizer and Teva;
Susan A. Gauthier: honoraria from Genzyme and Genentech; and research support from Biogen, EMD Serono, Genzyme, Mallinckrodt, and Novartis;
Steven J Greenberg: employee of and holds stock/stock options in AbbVie Inc.;
Ping Wang and Giorgio Giannattasio: employees of and hold stock/stock options in Biogen.
Supported by: Biogen and AbbVie Biotherapeutics Inc.
Biogen and AbbVie Biotherapeutics Inc. provided funding for medical writing support in the development of this abstract. Rebecca Jarvis (Excel Scientific Solutions, Southport, CT) wrote the first draft of the abstract based on input from authors. Biogen and AbbVie Biotherapeutics Inc. reviewed and provided feedback on the abstract. The authors had full editorial control of the abstract, and provided their final approval of all content.