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Efficacy and safety of satralizumab from two phase 3 trials in neuromyelitis optica spectrum disorder

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Abstract Number: 3173

AuthorBlock: Zdenka Haskova1, Benjamin Frishberg2, Jerome de Seze3, Brian Weinshenker4, Yusuke Terada5, Yuichi Kawata5, Athos Gianella-Borradori6, Christian von Büdingen7, Gaelle Klingelschmitt7, Anthony Traboulsee8, Takashi Yamamura9
1Genentech, Inc., South San Francisco, California, United States; 2The Neurology Center of Southern California, Carlsbad, California, United States; 3Department of Neurology, Hôpital de Hautepierre, , France; 4Mayo Clinic, Rochester, New York, United States; 5Chugai Pharmaceutical Co., Ltd, Tokyo, Japan; 6Chugai Pharma USA, Inc., Berkeley Heights, New Jersey, United States; 7F. Hoffmann-La Roche Ltd, Basel, Switzerland; 8The University of British Columbia, Vancouver, British Columbia, Canada; 9National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan;

DisclosureBlock: Zdenka Haskova, Genentech, Inc. Code E (Employment), F. Hoffmann-La Roche Ltd. Code I (Personal Financial Interest), Genentech, Inc. Code C (Consultant), Benjamin Frishberg, Genentech, Inc Code C (Consultant), Alexion Code R (Recipient), Biogen, Code R (Recipient), Genzyme Code R (Recipient), EMD Serono Code R (Recipient), Jerome de Seze, Roche Code F (Financial Support), Chugai Code F (Financial Support), Chugai Code R (Recipient), Brian Weinshenker, MedImmune Code C (Consultant), Alexion Code C (Consultant), Mitsubishi Tanabe Code R (Recipient), Chugai Code R (Recipient), RSR Ltd,Oxford University; Hospices Civils de Lyon, MVZ Labor PD Dr. Volkmann und Kollegen GbR. Code P (Patent), Yusuke Terada, Chugai Pharmaceutical Co Code E (Employment), Yuichi Kawata, 5Chugai Pharmaceutical Code E (Employment), Athos Gianella-Borradori, 6Chugai Pharma USA, Inc. Code E (Employment), Christian von Büdingen, F. Hoffmann-La Roche Ltd Code E (Employment), Gaelle Klingelschmitt, F. Hoffmann-La Roche Ltd Code E (Employment), Anthony Traboulsee, Chugai, Roche, and Sanofi Genzyme Code F (Financial Support), Consortium of Multiple Sclerosis Centers, MS Society of Canada, Biogen, Teva, Roche, Merck/EMD Serono, Sanofi Genzyme and Chugai Code R (Recipient), Takashi Yamamura, Biogen, Takeda, Sumitomo, Novartis Code R (Recipient), Chugai, Biogen, Novartis, Teva, Chiome Bioscience and Miraca Holdings Code F (Financial Support), Chugai, Takeda, Biogen, Sumitomo Dainippon, Mitsubishi Tanabe, Bayer, Japan Blood Products Organization, Otsuka, Kissei, Novartis, Chiome Bioscience, Miraca Holdings and Daiichi Sankyo Code R (Recipient)

Purpose
Neuromyelitis optica spectrum disorder (NMOSD) is a chronic, debilitating autoimmune disease of the central nervous system characterized by inflammatory lesions involving the optic nerves and spinal cord. Satralizumab is a humanized recycling monoclonal antibody that binds to the interleukin-6 (IL-6) receptor; IL-6 has been implicated in the pathophysiology of NMOSD. Satralizumab was evaluated in patients with NMOSD in two Phase 3 studies: SAkuraSky (NCT02028884) and SAkuraStar (NCT02073279). In this analysis, we assessed the efficacy and safety of satralizumab in the individual study and pooled patient populations, including the subgroup of patients who were seropositive for aquaporin-4 immunoglobulin G (AQP4-IgG).

Methods
Patients were randomized 1:1 (SAkuraSky; N=83) or 2:1 (SAkuraStar; N=95) to satralizumab (120 mg as monotherapy [SAkuraStar] or in combination with baseline immunosuppressants [SAkuraSky]) or placebo. The primary endpoint of both studies and the pooled analysis was time to first protocol-defined relapse (PDR). Between-group hazard ratios (HRs) were calculated based on Cox proportional hazards models.

Results
Compared with placebo, satralizumab reduced the risk of PDR by 62% (HR, 0.38 [95% CI 0.16–0.88]) in SAkuraSky and by 55% (HR, 0.45 [95% CI 0.23–0.89]) in SAkuraStar (both p=0.018). In AQP4-IgG–seropositive patients, risk of PDR was reduced in SAkuraSky (satralizumab, n=27; placebo, n=28) by 79% (HR 0.21 [95% CI 0.06–0.75]) and in SAkuraStar (satralizumab, n=41; placebo, n=23) by 74% (HR 0.26 [95% CI 0.11–0.63]). In the pooled analysis, HR for time to first PDR was 0.42 (95% CI 0.25–0.71; 58% risk reduction satralizumab vs placebo). In pooled analysis of AQP4-IgG–seropositive patients, the HR was 0.25 (95% CI 0.12–0.50; 75% risk reduction). Incidence of adverse events was similar in satralizumab and placebo groups; there were no deaths or anaphylactic reactions.

Conclusions
This analysis of data from two Phase 3 studies demonstrated the efficacy of satralizumab in reducing relapse risk in patients with NMOSD, particularly in AQP4-IgG–seropositive patients. Satralizumab had a favorable safety profile as monotherapy or in combination with immunosuppressants.

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