Efficacy and safety of satralizumab monotherapy for relapse prevention in neuromyelitis optica spectrum disorder (NMOSD): results from SAkuraStar, a double-blind placebo-controlled Phase 3 clinical study
ECTRIMS Online Library. Traboulsee A. 09/11/19; 278963; P603
Prof. Anthony Traboulsee
Prof. Anthony Traboulsee
Contributions
Abstract

Abstract: P603

Type: Poster Sessions

Abstract Category: Therapy - Immunomodulation/Immunosuppression

A. Traboulsee1, B. Greenberg2, J.L. Bennett3, L. Szczechowski4, E. Fox5, S. Shkrobot6, T. Yamamura7, Y. Terada8, Y. Kawata8, P. Wright9, H.-C. von Büdingen10, G. Klingelschmitt10, A. Gianella-Borradori11, B.G. Weinshenker12

1University of British Columbia, Vancouver, BC, Canada, 2University of Texas Southwestern Medical Center, Dallas, TX, 3University of Colorado School of Medicine, Aurora, CO, United States, 4Silesian Centre of Neurology, Katowice, Poland, 5Central Texas Neurology Consultants, Round Rock, TX, United States, 6Ternopil State Medical University, Ternopil, Ukraine, 7National Institute of Neuroscience, National Center of Neurology and Psychiatry, 8Chugai Pharmaceutical Co., Ltd, Tokyo, Japan, 9Chugai Pharmaceutical Co., Ltd, London, United Kingdom, 10F. Hoffmann-La Roche Ltd, Basel, Switzerland, 11Chugai Pharma USA LLC, Berkeley Heights, NJ, 12Mayo Clinic, Rochester, MN, United States

Background: Neuromyelitis optica spectrum disorder (NMOSD) is a debilitating, relapsing, autoimmune disease of the central nervous system (CNS), characterised by attacks targeting primarily the optic nerves and spinal cord. Interleukin-6 (IL-6) is a pro-inflammatory cytokine; several IL-6 effects have been implicated in the immune pathology of NMOSD. Satralizumab is a humanised recycling monoclonal antibody that binds to the IL-6 receptor. Satralizumab is designed to inhibit IL-6-driven proinflammatory signalling processes associated with NMOSD and, consequently, limit NMOSD disease activity.
Objective: To evaluate the efficacy and safety of satralizumab monotherapy compared with placebo for relapse prevention in patients with neuromyelitis optica (NMO) or NMOSD in the pivotal SAkuraStar study (NCT02073279).
Methods: In this Phase 3, double-blind, placebo-controlled study, 95 patients were randomised 2:1 to satralizumab (120 mg s.c.) or placebo, administered at Weeks 0, 2, 4 and every 4 weeks thereafter. Concomitant immunosuppressant medications were prohibited. Patients either met 2006 NMO diagnostic criteria (NMO) or were AQP4-IgG seropositive and had experienced ≥1 episode of optic neuritis or longitudinally extensive myelitis (NMOSD). All had ≥1 documented relapse, including first attack, in the year prior to screening. The primary endpoint was time to first protocol-defined relapse (PDR) adjudicated by a Clinical Endpoint Committee.
Results: Satralizumab monotherapy significantly reduced risk of PDR by 55% compared with placebo (hazard ratio 0.45; 95% confidence interval 0.23-0.89; p=0.018). The proportion of relapse-free patients at Week 48 was 76.1% in the satralizumab group, and 61.9% in the placebo group. At Week 96, these values were 72.1% and 51.2%, respectively. Satralizumab was well tolerated, and a similar proportion of patients in the satralizumab and placebo groups experienced adverse events. Rates of serious infections were similar between groups. No deaths or anaphylactic reactions were observed with satralizumab or placebo treatment.
Conclusions: In this first Phase 3 study of satralizumab as monotherapy in patients with NMO or NMOSD, patients treated with satralizumab had a significantly reduced risk of relapse compared with placebo. Satralizumab was well tolerated as monotherapy in both patients with NMO and NMOSD.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd.; writing and editorial assistance was provided by ApotheCom, UK.
Anthony Traboulsee received research funding from Chugai, Roche, and Sanofi Genzyme; received honoraria or travel support from Consortium of MS Centers, MS Society of Canada, Biogen, Teva, Roche, Merck/EMD Serono, Sanofi Genzyme, Chugai.
Benjamin Greenberg received grants from Chugai, MedImmune, Genentech, MedDay, PCORI, NIH, NMSS, and Guthy Jackson Charitable Foundation for NMO; and received consulting fees from Novartis, Alexion, Celgene, and EMD Serono. Dr Greenberg is an unpaid member of the board of the Transverse Myelitis Association.
Jeffrey L. Bennett served on scientific advisory boards and performed consulting services for EMD-Serono, Frequency Therapeutics, Clene Nanomedicine, Viela Bio, Alexion, and Chugai; received research support from Mallinckrodt; and has a patent (aquaporumab) issued.
Lech Szczechowski has nothing to disclose.
Edward Fox received compensation for research, consulting, speakers' bureau, and/or advisory work from Biogen, Celgene, Chugai, EMD Serono, Genentech/Roche, MedDay, Novartis, Sanofi Genzyme, Teva, and TG Therapeutics.
Svitlana Shkrobot has nothing to disclose.
Takashi Yamamura served on scientific advisory boards for Biogen, Takeda, Sumitomo, Novartis, and Chugai; received research grants from Chugai, Biogen, Novartis, Teva, Chiome Bioscience, and Miraca Holdings; and received speaker honoraria from Chugai, Takeda, Biogen, Sumitomo Dainippon, Mitsubishi Tanabe, Bayer, Japan Blood Products Organization, Otsuka, Kissei, Novartis, Chiome Bioscience, Miraca Holdings and Daiichi Sankyo.
Yusuke Terada is an employee of Chugai Pharmaceutical Co, Ltd.
Yuichi Kawata is an employee of Chugai Pharmaceutical Co, Ltd.
Pádraig Wright is an employee of Chugai Pharma Europe.
H. Christian von Büdingen is an employee of F. Hoffmann-La Roche Ltd.
Gaelle Klingelschmitt is an employee of F. Hoffmann-La Roche Ltd.
Athos Gianella-Borradori was an employee of Chugai Pharma USA, Inc and study physician at the time of the study.
Brian G. Weinshenker received consulting fees from MedImmune, Alexion - Participation on Attack Adjudication Committee; and personal fees from Chugai for the submitted work. He has a patent NMO-IgG for diagnosis of NMO with royalties paid to RSR Ltd; Oxford University; Hospices Civil de Lyon, MVZ Labor PD Dr Volkmann und Kollegen GbR.

Abstract: P603

Type: Poster Sessions

Abstract Category: Therapy - Immunomodulation/Immunosuppression

A. Traboulsee1, B. Greenberg2, J.L. Bennett3, L. Szczechowski4, E. Fox5, S. Shkrobot6, T. Yamamura7, Y. Terada8, Y. Kawata8, P. Wright9, H.-C. von Büdingen10, G. Klingelschmitt10, A. Gianella-Borradori11, B.G. Weinshenker12

1University of British Columbia, Vancouver, BC, Canada, 2University of Texas Southwestern Medical Center, Dallas, TX, 3University of Colorado School of Medicine, Aurora, CO, United States, 4Silesian Centre of Neurology, Katowice, Poland, 5Central Texas Neurology Consultants, Round Rock, TX, United States, 6Ternopil State Medical University, Ternopil, Ukraine, 7National Institute of Neuroscience, National Center of Neurology and Psychiatry, 8Chugai Pharmaceutical Co., Ltd, Tokyo, Japan, 9Chugai Pharmaceutical Co., Ltd, London, United Kingdom, 10F. Hoffmann-La Roche Ltd, Basel, Switzerland, 11Chugai Pharma USA LLC, Berkeley Heights, NJ, 12Mayo Clinic, Rochester, MN, United States

Background: Neuromyelitis optica spectrum disorder (NMOSD) is a debilitating, relapsing, autoimmune disease of the central nervous system (CNS), characterised by attacks targeting primarily the optic nerves and spinal cord. Interleukin-6 (IL-6) is a pro-inflammatory cytokine; several IL-6 effects have been implicated in the immune pathology of NMOSD. Satralizumab is a humanised recycling monoclonal antibody that binds to the IL-6 receptor. Satralizumab is designed to inhibit IL-6-driven proinflammatory signalling processes associated with NMOSD and, consequently, limit NMOSD disease activity.
Objective: To evaluate the efficacy and safety of satralizumab monotherapy compared with placebo for relapse prevention in patients with neuromyelitis optica (NMO) or NMOSD in the pivotal SAkuraStar study (NCT02073279).
Methods: In this Phase 3, double-blind, placebo-controlled study, 95 patients were randomised 2:1 to satralizumab (120 mg s.c.) or placebo, administered at Weeks 0, 2, 4 and every 4 weeks thereafter. Concomitant immunosuppressant medications were prohibited. Patients either met 2006 NMO diagnostic criteria (NMO) or were AQP4-IgG seropositive and had experienced ≥1 episode of optic neuritis or longitudinally extensive myelitis (NMOSD). All had ≥1 documented relapse, including first attack, in the year prior to screening. The primary endpoint was time to first protocol-defined relapse (PDR) adjudicated by a Clinical Endpoint Committee.
Results: Satralizumab monotherapy significantly reduced risk of PDR by 55% compared with placebo (hazard ratio 0.45; 95% confidence interval 0.23-0.89; p=0.018). The proportion of relapse-free patients at Week 48 was 76.1% in the satralizumab group, and 61.9% in the placebo group. At Week 96, these values were 72.1% and 51.2%, respectively. Satralizumab was well tolerated, and a similar proportion of patients in the satralizumab and placebo groups experienced adverse events. Rates of serious infections were similar between groups. No deaths or anaphylactic reactions were observed with satralizumab or placebo treatment.
Conclusions: In this first Phase 3 study of satralizumab as monotherapy in patients with NMO or NMOSD, patients treated with satralizumab had a significantly reduced risk of relapse compared with placebo. Satralizumab was well tolerated as monotherapy in both patients with NMO and NMOSD.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd.; writing and editorial assistance was provided by ApotheCom, UK.
Anthony Traboulsee received research funding from Chugai, Roche, and Sanofi Genzyme; received honoraria or travel support from Consortium of MS Centers, MS Society of Canada, Biogen, Teva, Roche, Merck/EMD Serono, Sanofi Genzyme, Chugai.
Benjamin Greenberg received grants from Chugai, MedImmune, Genentech, MedDay, PCORI, NIH, NMSS, and Guthy Jackson Charitable Foundation for NMO; and received consulting fees from Novartis, Alexion, Celgene, and EMD Serono. Dr Greenberg is an unpaid member of the board of the Transverse Myelitis Association.
Jeffrey L. Bennett served on scientific advisory boards and performed consulting services for EMD-Serono, Frequency Therapeutics, Clene Nanomedicine, Viela Bio, Alexion, and Chugai; received research support from Mallinckrodt; and has a patent (aquaporumab) issued.
Lech Szczechowski has nothing to disclose.
Edward Fox received compensation for research, consulting, speakers' bureau, and/or advisory work from Biogen, Celgene, Chugai, EMD Serono, Genentech/Roche, MedDay, Novartis, Sanofi Genzyme, Teva, and TG Therapeutics.
Svitlana Shkrobot has nothing to disclose.
Takashi Yamamura served on scientific advisory boards for Biogen, Takeda, Sumitomo, Novartis, and Chugai; received research grants from Chugai, Biogen, Novartis, Teva, Chiome Bioscience, and Miraca Holdings; and received speaker honoraria from Chugai, Takeda, Biogen, Sumitomo Dainippon, Mitsubishi Tanabe, Bayer, Japan Blood Products Organization, Otsuka, Kissei, Novartis, Chiome Bioscience, Miraca Holdings and Daiichi Sankyo.
Yusuke Terada is an employee of Chugai Pharmaceutical Co, Ltd.
Yuichi Kawata is an employee of Chugai Pharmaceutical Co, Ltd.
Pádraig Wright is an employee of Chugai Pharma Europe.
H. Christian von Büdingen is an employee of F. Hoffmann-La Roche Ltd.
Gaelle Klingelschmitt is an employee of F. Hoffmann-La Roche Ltd.
Athos Gianella-Borradori was an employee of Chugai Pharma USA, Inc and study physician at the time of the study.
Brian G. Weinshenker received consulting fees from MedImmune, Alexion - Participation on Attack Adjudication Committee; and personal fees from Chugai for the submitted work. He has a patent NMO-IgG for diagnosis of NMO with royalties paid to RSR Ltd; Oxford University; Hospices Civil de Lyon, MVZ Labor PD Dr Volkmann und Kollegen GbR.

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