Abstract: EP1649
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Treatment sequencing of disease-modifying therapies (DMTs) is a key consideration in the management of relapsing MS. Natalizumab is a highly effective DMT. However, some patients stop treatment with natalizumab because of reasons other than efficacy, primarily due to concerns about the risk of developing progressive multifocal leukoencephalopathy (PML). Identifying DMTs that can be effectively and safely used in the post-natalizumab treatment setting is a key unmet medical need. Daclizumab beta (DAC BETA) is a once monthly subcutaneous (SC) DMT for relapsing MS that offers high efficacy and a manageable safety profile through routine monitoring with no increased risk of opportunistic infections versus placebo or IM interferon beta-1a, and no cases of PML to date.
Objectives: To evaluate the efficacy and safety of DAC BETA in subjects who switch from natalizumab to DAC BETA.
Methods: SUSTAIN (NCT02881567) is a 12-month (mo), open-label, multicentre phase 3b study. Eligible adult relapsing-remitting MS (RRMS) subjects have: EDSS score 0-5.5; been treated with natalizumab for ≥12 months prior to screening without missing ≥2 consecutive doses; no relapse, increase in EDSS, Gd+ or new/newly enlarging T2 lesions in the last ≥6 months; and been enrolled within 28(+3) days of last natalizumab dose. At the end of the 28(+3) day period, subjects receive DAC BETA 150mg once monthly SC using a pre-filled pen during 12 mo of follow up. Study assessments occur at enrolment, baseline, and 1, 3, 4, 6, 9 and 12 mo with a safety follow-up visit 4 (EU sites) or 6 (US/Canada sites) mo after the last dose; brain MRI scans are performed at enrolment and 1, 4, 6 and 12 mo (all time points: pre-contrast T1, T2, PD, FLAIR; enrolment and 1, 4 and 6 mo: DWI; enrolment and 6 and 12 mo: post-contrast T1). The primary endpoint is the proportion of subjects relapse free at 6 mo; secondary endpoints include: incidence of AEs/serious AEs, proportion of subjects relapse free and annualised relapse rate at 12 mo; number of new Gd+, new T1 hypointense, and new/newly enlarging T2 hyperintense lesions at 6 and 12 mo; and rate of permanent discontinuation of DAC BETA at 12 mo.
Results: SUSTAIN is expected to enrol ~100 subjects. Enrolment is ongoing. Estimated study completion is early 2019.
Conclusions: Results from SUSTAIN will provide information about the efficacy and safety of DAC BETA in RRMS patients initiating this therapy after discontinuation of treatment with natalizumab.
Disclosure:
G. Giovannoni: advisory boards for AbbVie Biotherapeutics Inc., Biogen, Novartis, Merck, Merck Serono, Roche, Sanofi-Genzyme, and Teva; speaker fees from AbbVie Biotherapeutics Inc., Biogen, Genzyme, Merck Serono, Sanofi-Genzyme, and Teva; coeditor in chief of Multiple Sclerosis and Related Disorders; research support unrelated to study from Biogen, Genzyme, and Novartis.
V. Bhan: advisory boards for Biogen, Genzyme, EMD Serono, Novartis, Roche and Teva
D. Centonze: advisory boards and speaker fees for Almirall, Biogen, Celgene, Genzyme, Merck, Novartis, Roche, Teva, and Novartis; research support from Biogen, Genzyme, Merck, Novartis, Teva
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, Novartis, Opexa, and Roche.
T. Ziemssen: advisory boards, trial steering committees, data and safety monitoring committees for, and speaker fees and project support from Bayer HealthCare, Biogen, Elan, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, Synthon and Teva.
L. Chiodo: Employee of and holds stock/stock options in AbbVie Inc.
J. Easter, X. Jiang, S. Fam, G. Giannattasio: Employee of and holds 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: EP1649
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Treatment sequencing of disease-modifying therapies (DMTs) is a key consideration in the management of relapsing MS. Natalizumab is a highly effective DMT. However, some patients stop treatment with natalizumab because of reasons other than efficacy, primarily due to concerns about the risk of developing progressive multifocal leukoencephalopathy (PML). Identifying DMTs that can be effectively and safely used in the post-natalizumab treatment setting is a key unmet medical need. Daclizumab beta (DAC BETA) is a once monthly subcutaneous (SC) DMT for relapsing MS that offers high efficacy and a manageable safety profile through routine monitoring with no increased risk of opportunistic infections versus placebo or IM interferon beta-1a, and no cases of PML to date.
Objectives: To evaluate the efficacy and safety of DAC BETA in subjects who switch from natalizumab to DAC BETA.
Methods: SUSTAIN (NCT02881567) is a 12-month (mo), open-label, multicentre phase 3b study. Eligible adult relapsing-remitting MS (RRMS) subjects have: EDSS score 0-5.5; been treated with natalizumab for ≥12 months prior to screening without missing ≥2 consecutive doses; no relapse, increase in EDSS, Gd+ or new/newly enlarging T2 lesions in the last ≥6 months; and been enrolled within 28(+3) days of last natalizumab dose. At the end of the 28(+3) day period, subjects receive DAC BETA 150mg once monthly SC using a pre-filled pen during 12 mo of follow up. Study assessments occur at enrolment, baseline, and 1, 3, 4, 6, 9 and 12 mo with a safety follow-up visit 4 (EU sites) or 6 (US/Canada sites) mo after the last dose; brain MRI scans are performed at enrolment and 1, 4, 6 and 12 mo (all time points: pre-contrast T1, T2, PD, FLAIR; enrolment and 1, 4 and 6 mo: DWI; enrolment and 6 and 12 mo: post-contrast T1). The primary endpoint is the proportion of subjects relapse free at 6 mo; secondary endpoints include: incidence of AEs/serious AEs, proportion of subjects relapse free and annualised relapse rate at 12 mo; number of new Gd+, new T1 hypointense, and new/newly enlarging T2 hyperintense lesions at 6 and 12 mo; and rate of permanent discontinuation of DAC BETA at 12 mo.
Results: SUSTAIN is expected to enrol ~100 subjects. Enrolment is ongoing. Estimated study completion is early 2019.
Conclusions: Results from SUSTAIN will provide information about the efficacy and safety of DAC BETA in RRMS patients initiating this therapy after discontinuation of treatment with natalizumab.
Disclosure:
G. Giovannoni: advisory boards for AbbVie Biotherapeutics Inc., Biogen, Novartis, Merck, Merck Serono, Roche, Sanofi-Genzyme, and Teva; speaker fees from AbbVie Biotherapeutics Inc., Biogen, Genzyme, Merck Serono, Sanofi-Genzyme, and Teva; coeditor in chief of Multiple Sclerosis and Related Disorders; research support unrelated to study from Biogen, Genzyme, and Novartis.
V. Bhan: advisory boards for Biogen, Genzyme, EMD Serono, Novartis, Roche and Teva
D. Centonze: advisory boards and speaker fees for Almirall, Biogen, Celgene, Genzyme, Merck, Novartis, Roche, Teva, and Novartis; research support from Biogen, Genzyme, Merck, Novartis, Teva
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, Novartis, Opexa, and Roche.
T. Ziemssen: advisory boards, trial steering committees, data and safety monitoring committees for, and speaker fees and project support from Bayer HealthCare, Biogen, Elan, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, Synthon and Teva.
L. Chiodo: Employee of and holds stock/stock options in AbbVie Inc.
J. Easter, X. Jiang, S. Fam, G. Giannattasio: Employee of and holds 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.