Contributions
Abstract: 206
Type: Oral
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: EXTEND is an ongoing long-term open-label extension study to assess safety and efficacy of daclizumab beta (DAC BETA) in patients with relapsing MS (RMS) who completed DECIDE or transitioned from SELECTED or OBSERVE.
Objective: Report long-term safety outcomes of DAC BETA in patients who completed DECIDE and enrolled in EXTEND.
Methods: Patients who received DAC BETA or intramuscular (IM) interferon (IFN)-beta-1a in DECIDE receive open-label DAC BETA 150mg subcutaneous every 4 weeks for up to 5 years in EXTEND. An interim analysis of safety outcomes for the DECIDE/EXTEND combined treatment period was performed using data through Sept 9, 2016. Safety analyses included all patients who received ≥1 dose of DAC BETA as part of DECIDE or who switched from IM IFN beta-1a in DECIDE to DAC BETA in EXTEND.
Results: This interim analysis included 1516 patients who received ≥1 dose of DAC BETA in DECIDE or EXTEND (exposure: 4637 patient-years; median [range], 34.0 [1-83] doses). In the DECIDE/EXTEND combined treatment period, overall incidence of any adverse event (AE) was 92%, AEs related to treatment (as determined by investigator) was 52%, and serious AEs excluding MS relapse was 20%. Twenty-two percent of patients discontinued treatment due to AEs, including 7% who discontinued due to hepatic AEs, 6% cutaneous AEs, and 1% infections. Overall incidence of infections, cutaneous AEs, hepatic AEs and lymphadenopathy events were 67%, 42%, 19%, and 9%, respectively. Incidence of serious potentially opportunistic infections was < 1%. Autoimmune hemolytic anaemia (AIHA) was observed in 3 patients; 2 of the cases were considered possibly related to DAC BETA treatment. In the DECIDE/EXTEND combined treatment period, overall incidence of AEs, serious AEs, and AEs leading to discontinuation remained stable over time (examined by 1-year interval), as did incidence of infection, cutaneous AEs, hepatic AEs, and lymphadenopathy events. Also, incidence of mild, moderate, and severe AEs by 1-year interval was stable over time.
Conclusions: In the DECIDE/EXTEND combined treatment period, in which some patients received DAC BETA for >5 years, incidence of AEs remained stable when evaluated in 1-year intervals. Despite the addition of AIHA as a new safety risk, the safety profile remained consistent with previous observations and, together with EXTEND efficacy data, supports a continued favourable long-term benefit/risk profile of DAC BETA in RMS.
Disclosure: 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
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
J. Holman: employee of and hold stock/stock options in AbbVie Inc.
H. Chen, S. Fam, B. Parks: 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: 206
Type: Oral
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: EXTEND is an ongoing long-term open-label extension study to assess safety and efficacy of daclizumab beta (DAC BETA) in patients with relapsing MS (RMS) who completed DECIDE or transitioned from SELECTED or OBSERVE.
Objective: Report long-term safety outcomes of DAC BETA in patients who completed DECIDE and enrolled in EXTEND.
Methods: Patients who received DAC BETA or intramuscular (IM) interferon (IFN)-beta-1a in DECIDE receive open-label DAC BETA 150mg subcutaneous every 4 weeks for up to 5 years in EXTEND. An interim analysis of safety outcomes for the DECIDE/EXTEND combined treatment period was performed using data through Sept 9, 2016. Safety analyses included all patients who received ≥1 dose of DAC BETA as part of DECIDE or who switched from IM IFN beta-1a in DECIDE to DAC BETA in EXTEND.
Results: This interim analysis included 1516 patients who received ≥1 dose of DAC BETA in DECIDE or EXTEND (exposure: 4637 patient-years; median [range], 34.0 [1-83] doses). In the DECIDE/EXTEND combined treatment period, overall incidence of any adverse event (AE) was 92%, AEs related to treatment (as determined by investigator) was 52%, and serious AEs excluding MS relapse was 20%. Twenty-two percent of patients discontinued treatment due to AEs, including 7% who discontinued due to hepatic AEs, 6% cutaneous AEs, and 1% infections. Overall incidence of infections, cutaneous AEs, hepatic AEs and lymphadenopathy events were 67%, 42%, 19%, and 9%, respectively. Incidence of serious potentially opportunistic infections was < 1%. Autoimmune hemolytic anaemia (AIHA) was observed in 3 patients; 2 of the cases were considered possibly related to DAC BETA treatment. In the DECIDE/EXTEND combined treatment period, overall incidence of AEs, serious AEs, and AEs leading to discontinuation remained stable over time (examined by 1-year interval), as did incidence of infection, cutaneous AEs, hepatic AEs, and lymphadenopathy events. Also, incidence of mild, moderate, and severe AEs by 1-year interval was stable over time.
Conclusions: In the DECIDE/EXTEND combined treatment period, in which some patients received DAC BETA for >5 years, incidence of AEs remained stable when evaluated in 1-year intervals. Despite the addition of AIHA as a new safety risk, the safety profile remained consistent with previous observations and, together with EXTEND efficacy data, supports a continued favourable long-term benefit/risk profile of DAC BETA in RMS.
Disclosure: 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
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
J. Holman: employee of and hold stock/stock options in AbbVie Inc.
H. Chen, S. Fam, B. Parks: 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.