Contributions
Abstract: P1278
Type: Poster Sessions
Abstract Category: Therapy - Others
Objective: Neuromyelitis optica spectrum disorder (NMOSD) is an auto-immune-inflammatory disease of the central nervous system that predominantly target optic nerves and spinal cord. It is usually associated with aquaporin-4 (AQP4) auto-antibody. Interleukin (IL)-6 stimulates antibody production by plasmablasts and increases blood-brain-barrier permeability, thereby contributing to both the production and central nervous system penetration of pathologenic AQP4 auto-antibody. Satralizumab is a recycling anti-IL-6 receptor monoclonal antibody with a long half-life, designed for s.c. injection.
Methods: SAkuraStar study (NCT02073279) is a randomized, placebo-controlled, double-blind study of satralizumab for the prevention of NMOSD relapses. Protocol defined relapses (PDRs) are evaluated by a central adjudication committee. Subjects are randomized 2:1 to satralizumab (120mg s.c.) or placebo given at Weeks 0, 2, 4, and Q4W thereafter. Concomitant use of immunosuppressive agents was not allowed. The primary endpoint was time to first PDR; key secondary endpoints were change in visual analogue scale (VAS) score for pain and functional assessment of chronic illness therapy fatigue score.
Main inclusion criteria: Patients age 18-74 with NMO defined according to Wingerchuk criteria (with or without AQP4-IgG serologic marker), or NMOSD who were AQP4-IgG seropositive. Patients must have experienced at least 1 documented relapse (including first attack) in last 12 months prior to screening.
Results: SAkuraStar study enrollment is complete (95 patients). 77/95 (81.1%) were females; the mean age was 43.7±11.7; 77/94 (81.9%) reported scores >0 on the pain VAS at baseline.
Conclusions: The SAkuraStar study is designed to evaluate the safety and efficacy of satralizumab monotherapy compared with placebo in patients with NMOSD not receiving any other immunosuppressive treatment, and final analysis is pending the accumulation of the required number of PDR.
Disclosure: This study was funded by Chugai Pharmaceutical Co. Ltd, Tokyo, Japan. Detailed disclosures of each author will be included in the ePresentation.
A. Traboulsee has received grants for clinical trial participation, MRI analysis and consultant honoraria from Chugai, grants and personal fees from Biogen, grants and Consulting fees from Roche, grants and speaker´s bureau fees from Sanofi Genzyme, grants and Consulting fees from Teva.
B. Greenberg has received grants from Chugai, Medimmune, Genentech, Medday, PCORI, NIH, NMSS and Guthy Jackson Charitable Foundation for NMO; received Consulting fees from Novartis and Alexion.
J.L. Bennett has received consulting fees from Chugai, VielaBio, Genentech, EMD Serono, Genzyme, AbbVie, Teva Neuroscience, Equillium Inc, Clene Nanomedicine, Frequency Therapeutics, and Novartis; received grants from EMD Serono, Guthy Jackson Charitable Foundation, National Multiple Sclerosis Society, National Eye Institute; has a patent Aquaporumab issued.
L. Szczechowski: nothing to disclose.
E. Fox has received honorarium for consulting, advisory, or speaker´s bureau activity for Acorda, Bayer, Biogen, EMD Serono, Genentech Roche, Novartis, Sanofi Genzyme, and Teva; received research compensation provided by Acorda, Biogen, Celgene, Chugai, Genentech Roche, Mallinckrodt, MedDay, Novartis, Teva, and TG Therapeutics.
S. Shkrobot: nothing to disclose.
T. Yamamura has served on scientific advisory boards for Takeda and Chugai; received research grants from Ono, Chugai, Biogen, and Novartis; received speaker honoraria from Chugai, Ono, Takeda, Biogen, Sumitomo Dainippon, Mitsubishi Tanabe, Human Metabolome Technologies, Bayer, Japan Blood Products Organization, Otsuka, Kissei, and Daiichi Sankyo.
B. Weinshenker has received royalties from RSR Ltd, Oxford University, Hospices Civil de Lyon, and MVZ Labor PD Dr. Volkmann und Kollegen GbR for a patent of NMO-IgG as a diagnostic test for NMO and related disorders; has been a consultant for Chugai, Caladrius Biosciences, Brainstorm Therapeutics and Roivant Sciences regarding potential clinical trials for NMO; has served as a member of an adjudication committee for clinical trials in NMO being conducted by VielaBio and Alexion pharmaceutical companies, and as that of a data safety monitoring committee for clinical trials conducted by Novartis.
Y. Terada and Y. Kawata are employees of Chugai Pharmaceuticals Co., Ltd.
A. Gianella-Borradori is an employee of Chugai Pharma Europe and A. Melia is an employee of Chugai Pharma USA.
Abstract: P1278
Type: Poster Sessions
Abstract Category: Therapy - Others
Objective: Neuromyelitis optica spectrum disorder (NMOSD) is an auto-immune-inflammatory disease of the central nervous system that predominantly target optic nerves and spinal cord. It is usually associated with aquaporin-4 (AQP4) auto-antibody. Interleukin (IL)-6 stimulates antibody production by plasmablasts and increases blood-brain-barrier permeability, thereby contributing to both the production and central nervous system penetration of pathologenic AQP4 auto-antibody. Satralizumab is a recycling anti-IL-6 receptor monoclonal antibody with a long half-life, designed for s.c. injection.
Methods: SAkuraStar study (NCT02073279) is a randomized, placebo-controlled, double-blind study of satralizumab for the prevention of NMOSD relapses. Protocol defined relapses (PDRs) are evaluated by a central adjudication committee. Subjects are randomized 2:1 to satralizumab (120mg s.c.) or placebo given at Weeks 0, 2, 4, and Q4W thereafter. Concomitant use of immunosuppressive agents was not allowed. The primary endpoint was time to first PDR; key secondary endpoints were change in visual analogue scale (VAS) score for pain and functional assessment of chronic illness therapy fatigue score.
Main inclusion criteria: Patients age 18-74 with NMO defined according to Wingerchuk criteria (with or without AQP4-IgG serologic marker), or NMOSD who were AQP4-IgG seropositive. Patients must have experienced at least 1 documented relapse (including first attack) in last 12 months prior to screening.
Results: SAkuraStar study enrollment is complete (95 patients). 77/95 (81.1%) were females; the mean age was 43.7±11.7; 77/94 (81.9%) reported scores >0 on the pain VAS at baseline.
Conclusions: The SAkuraStar study is designed to evaluate the safety and efficacy of satralizumab monotherapy compared with placebo in patients with NMOSD not receiving any other immunosuppressive treatment, and final analysis is pending the accumulation of the required number of PDR.
Disclosure: This study was funded by Chugai Pharmaceutical Co. Ltd, Tokyo, Japan. Detailed disclosures of each author will be included in the ePresentation.
A. Traboulsee has received grants for clinical trial participation, MRI analysis and consultant honoraria from Chugai, grants and personal fees from Biogen, grants and Consulting fees from Roche, grants and speaker´s bureau fees from Sanofi Genzyme, grants and Consulting fees from Teva.
B. Greenberg has received grants from Chugai, Medimmune, Genentech, Medday, PCORI, NIH, NMSS and Guthy Jackson Charitable Foundation for NMO; received Consulting fees from Novartis and Alexion.
J.L. Bennett has received consulting fees from Chugai, VielaBio, Genentech, EMD Serono, Genzyme, AbbVie, Teva Neuroscience, Equillium Inc, Clene Nanomedicine, Frequency Therapeutics, and Novartis; received grants from EMD Serono, Guthy Jackson Charitable Foundation, National Multiple Sclerosis Society, National Eye Institute; has a patent Aquaporumab issued.
L. Szczechowski: nothing to disclose.
E. Fox has received honorarium for consulting, advisory, or speaker´s bureau activity for Acorda, Bayer, Biogen, EMD Serono, Genentech Roche, Novartis, Sanofi Genzyme, and Teva; received research compensation provided by Acorda, Biogen, Celgene, Chugai, Genentech Roche, Mallinckrodt, MedDay, Novartis, Teva, and TG Therapeutics.
S. Shkrobot: nothing to disclose.
T. Yamamura has served on scientific advisory boards for Takeda and Chugai; received research grants from Ono, Chugai, Biogen, and Novartis; received speaker honoraria from Chugai, Ono, Takeda, Biogen, Sumitomo Dainippon, Mitsubishi Tanabe, Human Metabolome Technologies, Bayer, Japan Blood Products Organization, Otsuka, Kissei, and Daiichi Sankyo.
B. Weinshenker has received royalties from RSR Ltd, Oxford University, Hospices Civil de Lyon, and MVZ Labor PD Dr. Volkmann und Kollegen GbR for a patent of NMO-IgG as a diagnostic test for NMO and related disorders; has been a consultant for Chugai, Caladrius Biosciences, Brainstorm Therapeutics and Roivant Sciences regarding potential clinical trials for NMO; has served as a member of an adjudication committee for clinical trials in NMO being conducted by VielaBio and Alexion pharmaceutical companies, and as that of a data safety monitoring committee for clinical trials conducted by Novartis.
Y. Terada and Y. Kawata are employees of Chugai Pharmaceuticals Co., Ltd.
A. Gianella-Borradori is an employee of Chugai Pharma Europe and A. Melia is an employee of Chugai Pharma USA.