Contributions
Abstract: P653
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: EXTEND is an ongoing open-label extension study of DECIDE to assess the safety and efficacy of daclizumab high-yield process (DAC HYP) treatment in relapsing-remitting multiple sclerosis (RRMS).
Objective: To assess long-term safety and efficacy of DAC HYP in RRMS.
Methods: Patients enrolled in EXTEND receive DAC HYP 150mg subcutaneous every 4 weeks for up to 5 years. An interim analysis of safety and efficacy endpoints was performed using data through Jan 11, 2016 (patients enrolled in pre-filled pen [PFP] substudy) or Sep 10, 2015 (non-PFP patients). Safety analyses included patients who completed DECIDE and enrolled in EXTEND. Analyses of 24-week confirmed disability progression (CDP) were performed for the combined DECIDE and EXTEND treatment periods and included all patients in the DECIDE intention-to-treat population.
Results: Safety analyses included 1203 subjects, 597 of whom received intramuscular interferon (IFN) beta-1a in DECIDE and switched to DAC HYP in EXTEND (IFN/DAC) and 606 of whom received DAC HYP in DECIDE and continued in EXTEND (DAC/DAC). Among IFN/DAC patients, the incidence of treatment-emergent serious adverse events other than MS relapse was similar after a median of approximately 18 months of DAC HYP in EXTEND as compared to a median of 26 months of IFN beta-1a exposure in IFN-treated patients in DECIDE (9% vs.10%). The annualized relapse rate (ARR) decreased from 0.317 to 0.152 after switching from IFN beta-1a to DAC HYP in EXTEND. Among DAC/DAC patients (n=606), ARR was similar in DECIDE and EXTEND (0.195 vs 0.156). In the combined DECIDE/EXTEND study period, patients treated with DAC HYP from DECIDE Baseline up to Week 168 had a 21% relative risk reduction for 24-week confirmed disability progression as compared with patients who were treated with IFN beta-1a (HR: 0.79; 95%CI: 0.62-1.00; P=.047).
Conclusion: The safety profile of DAC HYP in EXTEND was consistent with that from DECIDE. Long-term treatment with DAC HYP was associated with a reduction in the relapse rate and confirmed disability progression when compared to earlier treatment with IFN beta-1a.
Disclosure:
Ludwig Kappos: Institution (University Hospital Basel) received in the last 3 years and used exclusively for research support: steering committee for and 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; Dr. Kappos has also 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.
Stanley Cohan: paid consultant to serve on advisory boards for Biogen, Mallinckrodt, Novartis, and Sanofi-Genzyme; honoraria from speaker bureaus for Acorda, Biogen, Genentech, Novartis, and Sanofi-Genzyme; research support from Biogen, Genentech, Mallinckrodt, Novartis, Opexa, Roche, and Sanofi-Genzyme; funds for transportation, meals, and lodging from Acorda, Biogen, Mallinckrodt, Novartis, and Sanofi-Genzyme.
Douglas L Arnold: honoraria from Bayer HealthCare, Biogen, EMD Serono, Genentech, Genzyme, GlaxoSmithKline, Merck Serono, Novartis, Roche, and Teva; employee of and stockholder in NeuroRx Research.
Oksana Mokliatchouk, Peter McCroskery, and Gabriel Lima: employees of and hold stock/stock options in Biogen.
Steven Greenberg: employee of and holds stock/stock options in AbbVie Inc.
Supported by: Biogen and AbbVie Biotherapeutics Inc.
Biogen and AbbVie Biotherapeutics Inc. provided funding for medical writing support in the development of this abstract. Stephanie Douglas (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: P653
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: EXTEND is an ongoing open-label extension study of DECIDE to assess the safety and efficacy of daclizumab high-yield process (DAC HYP) treatment in relapsing-remitting multiple sclerosis (RRMS).
Objective: To assess long-term safety and efficacy of DAC HYP in RRMS.
Methods: Patients enrolled in EXTEND receive DAC HYP 150mg subcutaneous every 4 weeks for up to 5 years. An interim analysis of safety and efficacy endpoints was performed using data through Jan 11, 2016 (patients enrolled in pre-filled pen [PFP] substudy) or Sep 10, 2015 (non-PFP patients). Safety analyses included patients who completed DECIDE and enrolled in EXTEND. Analyses of 24-week confirmed disability progression (CDP) were performed for the combined DECIDE and EXTEND treatment periods and included all patients in the DECIDE intention-to-treat population.
Results: Safety analyses included 1203 subjects, 597 of whom received intramuscular interferon (IFN) beta-1a in DECIDE and switched to DAC HYP in EXTEND (IFN/DAC) and 606 of whom received DAC HYP in DECIDE and continued in EXTEND (DAC/DAC). Among IFN/DAC patients, the incidence of treatment-emergent serious adverse events other than MS relapse was similar after a median of approximately 18 months of DAC HYP in EXTEND as compared to a median of 26 months of IFN beta-1a exposure in IFN-treated patients in DECIDE (9% vs.10%). The annualized relapse rate (ARR) decreased from 0.317 to 0.152 after switching from IFN beta-1a to DAC HYP in EXTEND. Among DAC/DAC patients (n=606), ARR was similar in DECIDE and EXTEND (0.195 vs 0.156). In the combined DECIDE/EXTEND study period, patients treated with DAC HYP from DECIDE Baseline up to Week 168 had a 21% relative risk reduction for 24-week confirmed disability progression as compared with patients who were treated with IFN beta-1a (HR: 0.79; 95%CI: 0.62-1.00; P=.047).
Conclusion: The safety profile of DAC HYP in EXTEND was consistent with that from DECIDE. Long-term treatment with DAC HYP was associated with a reduction in the relapse rate and confirmed disability progression when compared to earlier treatment with IFN beta-1a.
Disclosure:
Ludwig Kappos: Institution (University Hospital Basel) received in the last 3 years and used exclusively for research support: steering committee for and 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; Dr. Kappos has also 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.
Stanley Cohan: paid consultant to serve on advisory boards for Biogen, Mallinckrodt, Novartis, and Sanofi-Genzyme; honoraria from speaker bureaus for Acorda, Biogen, Genentech, Novartis, and Sanofi-Genzyme; research support from Biogen, Genentech, Mallinckrodt, Novartis, Opexa, Roche, and Sanofi-Genzyme; funds for transportation, meals, and lodging from Acorda, Biogen, Mallinckrodt, Novartis, and Sanofi-Genzyme.
Douglas L Arnold: honoraria from Bayer HealthCare, Biogen, EMD Serono, Genentech, Genzyme, GlaxoSmithKline, Merck Serono, Novartis, Roche, and Teva; employee of and stockholder in NeuroRx Research.
Oksana Mokliatchouk, Peter McCroskery, and Gabriel Lima: employees of and hold stock/stock options in Biogen.
Steven Greenberg: employee of and holds stock/stock options in AbbVie Inc.
Supported by: Biogen and AbbVie Biotherapeutics Inc.
Biogen and AbbVie Biotherapeutics Inc. provided funding for medical writing support in the development of this abstract. Stephanie Douglas (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.