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A double-blind placebo-controlled study of satralizumab (SA237), a recycling anti-IL-6 receptor monoclonal antibody, as add-on therapy for neuromyelitis optica spectrum disorder (NMOSD)
ECTRIMS Online Library. Yamamura T. Oct 12, 2018; 232076
Takashi Yamamura
Takashi Yamamura
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Abstract: 323

Type: Scientific Session

Abstract Category: N/A

Objective: Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune-inflammatory disease usually associated with aquaporin-4 (AQP4) autoantibodies that predominantly target optic nerves and the spinal cord. Interleukin-6 (IL-6) triggers inflammatory T and B cell responses, stimulating antibody production by plasmablasts and increases blood-brain-barrier permeability, thus permitting the penetration of pathological autoantibodies into the central nervous system. Satralizumab is a recycling anti-IL-6 receptor monoclonal antibody with a long plasma circulation. We present the results of a randomized, multicenter, international, double-blind, placebo-controlled study of satralizumab, the SAkuraSky study (NCT02028884).
Methods: The study is a randomized, double-blind, phase 3 study of satralizumab compared to placebo as add-on to baseline treatment (immunosuppressants or corticosteroids, both at a stable dose). Subjects were randomized to satralizumab (120 mg s.c.) or placebo given at weeks 0, 2, 4, and Q4W thereafter. The primary endpoint was time to first protocol defined relapse (PDR), which is evaluated by a central adjudication committee. Key secondary endpoints were change in visual analogue scale (VAS) score for pain and functional assessment of chronic illness therapy fatigue score. The inclusion criteria were: adult (aged 18 to 74 years) and adolescent (aged 12 to 17 years) patients with NMO by 2006 Wingerchuk criteria (any serostatus), or NMOSD by 2007 Wingerchuk criteria with anti-AQP4 antibody seropositive status; and at least 2 relapses in the last 2 years prior to screening, at least one of which occurred in the last 12 months.
Results: For primary analysis, 83 patients were randomized. Mean age at baseline was 42.1 years; 92.8% of total patients were females (77 patients); 54.2% were Caucasian and 42.2% were Asian. The number of patients with anti-AQP4 antibody seropositive status at screening was 55 (66.3%). Mean (standard deviation, SD) duration since NMOSD onset was 4.88 years (4.78). At baseline, mean (SD) annual relapse rate was 1.44 (0.53); median (range) EDSS was 3.5 (1, 6.5); 68/83 (81.9%) patients reported pain (VAS > 0).
Conclusions: The SAkuraSky study was designed to evaluate the safety and efficacy of satralizumab compared with placebo in patients with NMOSD. The double-blind period has been completed as the required number of relapses (26) has been accumulated. Key results from this study will be presented at the conference.
Disclosure: This study was funded by Chugai Pharmaceutical Co. Ltd, Tokyo, Japan. Detailed disclosures of each author will be included in the Presentation.
J. De Seze has received grants and personal fees from Roche, personal fees from Chugai; and has served advisory boards in Expert committee for the clinical trial conducted by Chugai.
I. Kleiter has received grants from Chugai and Diamed; and received personal fees from Chugai, Biogen, Merck, Novartis, Shire, Roche, and Bayer.
K. Fujihara has received grants from Ministry of Education of Japan, Ministry of Health, Welfare and Labor of Japan, Alexion, Chemo-Sero-Therapeutic Research Institute, Teva, Teijin, and Genzyme Japan; received grants and personal fees from Chugai, Bayer, Biogen, Mitsubishi Tanabe, Ono, Nihon Phamaceutical, and Asahi Kasei; and received personal fees from Novartis, Merck Serono, Medimmune, Eisai, Astellas, Takeda, Daiichi Sankyo, and Cosmic Corporation.
J. Palace has received grants from the MS society and Guthy-Jackson Charitable Foundation, Merck Serono, Novartis, Biogen Idec, Teva, Abide and Bayer Schering, and is partly funded by highly specialised services to run a national congenital myasthenia service and a neuromyelitis service; received support for scientific meetings and honorariums for advisory work from Merck Serono, Biogen Idec, Novartis, Teva, Chugai, Bayer Schering, Alexion, Roche, Genzyme, MedImmune, EuroImmun, MedDay, Abide and ARGENX, and her hospital trust received funds for her role as clinical lead for the RSS.
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.
B. Zakrzewska-Pniewska has received and/or receives support for scientific meetings and honoraria for advisory work from Roche, Chugai, Biogen, Merck, Novartis, Bayer, Medimmune, Teva, Sanofi Aventis, and Allergan.
F. Patti has received personal compensation for advisory board activities by Almirall, Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi Genzyme and TEVA.
C-P. Tsai has nothing to disclose.
A. Saiz has received consulting fees and speaker honoraria from Merck-Serono, Sanofi, Biogen, Roche, TEVA, Novartis, and Bayer-Schering.
T. Yamamura has served on scientific advisory boards for Biogen, Takeda, Ono, Sumitomo Dainippon, Novartis, and Chugai; received research grants from Chugai, Biogen, Novartis, Takeda, Teva, Nihon Phamaceutical; received speaker honoraria from Chugai, Ono, Takeda, Biogen, Sumitomo Dainippon, Mitsubishi Tanabe, Human Metabolome Technologies, Bayer, Japan Blood Products Organization, Otsuka, Kissei, Novartis, and Daiichi Sankyo.
Y. Terada and Y. Kawata are employees of Chugai Pharmaceuticals Co., Ltd.
P. Wright is an employee of Chugai Pharma Europe.

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