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Abstract Details

Long-term Safety of Satralizumab in Adults with Aquaporin-4-IgG-seropositive (AQP4-IgG+) Neuromyelitis Optica Spectrum Disorder (NMOSD): Results from SAkuraMoon
Autoimmune Neurology
P13 - Poster Session 13 (8:00 AM-9:00 AM)
6-002
Satralizumab reduced relapse risk and showed a favorable safety profile vs placebo in the double-blind periods (DBPs) and open-label extensions (OLEs) of two pivotal phase 3 trials in patients with NMOSD: SAkuraSky (NCT02028884; satralizumab + baseline immunosuppressants [IST]) and SAkuraStar (NCT02073279; satralizumab monotherapy).
To evaluate the long-term safety of satralizumab in adults with AQP4-IgG+ NMOSD. 
Patients who completed the DBPs and OLEs of SAkuraSky and SAkuraStar were rolled-over into a single-arm, open-label study (SAkuraMoon [NCT04660539]), where they continued receiving subcutaneous satralizumab 120mg Q4W ± IST. We evaluated all AQP4-IgG+ adults (≥18 years) who received ≥1 dose of satralizumab during these studies (data cut-off: 31 January 2022), defined as the overall satralizumab treatment (OST) period. Safety assessments compared the rates of adverse events (AEs) and rates of infections per 100 patient-years (PY) in the OST vs the DBPs.
Overall, 106 AQP4-IgG+ adults were included. The median (range) satralizumab exposure in the OST period was 5.0 (0.1–7.9) years. Rates of AEs and serious AEs (95% CI) in the OST were comparable with the DBP (AEs: 332.6 [316.7–349.1]/100 PY; serious AEs: 10.5 [7.8–13.8]/100 PY). Rates of infections (92.9 [84.6–101.8]/100 PY) and serious infections (2.4 [1.3–4.2]/100 PY) in the OST period were comparable with the DBP and did not increase over time. There were no deaths, anaphylactic reactions related to satralizumab, or injection-related reactions that led to changes in study treatment.
These results demonstrate that the safety of satralizumab (±IST) observed in the DBPs is sustained with long-term treatment over a median treatment exposure of 5 years. No new safety findings in the OST period vs the DBPs were observed.
Authors/Disclosures
Shervin Gholizadeh
PRESENTER
Mr. Gholizadeh has received personal compensation for serving as an employee of Genentech.
Brian G. Weinshenker, MD, FAAN (University of Virginia Health System) Dr. Weinshenker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Weinshenker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CANbridge Pharmaceuticals. Dr. Weinshenker has received personal compensation in the range of $0-$499 for serving as a Consultant for CALIBR. Dr. Weinshenker has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Horizon. Dr. Weinshenker has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Weinshenker has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Viela Bio. Dr. Weinshenker has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche Group (Chugai, Genentech, Roche). Dr. Weinshenker has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB Pharmaceuticals. The institution of Dr. Weinshenker has received research support from Guthy Jackson Charitable Foundation. Dr. Weinshenker has received intellectual property interests from a discovery or technology relating to health care. Dr. Weinshenker has received personal compensation in the range of $5,000-$9,999 for serving as a speaker at internal meeting and symposium with Horizon.
Michael R. Yeaman, PhD (UCLA ) Dr. Yeaman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Yeaman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Genentech-Roche. Dr. Yeaman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. The institution of Dr. Yeaman has received research support from National Institutes of Health. The institution of Dr. Yeaman has received research support from U.S. Department of Defense. Dr. Yeaman has received intellectual property interests from a discovery or technology relating to health care. Dr. Yeaman has received intellectual property interests from a discovery or technology relating to health care.
Jerome De Seze Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma.
Francesco Patti, MD Dr. Patti has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion, Almirall, Bayer, Biogen, Bristol Meyers and Squibb Merck, Roche, Sanofi, TEVA. Dr. Patti has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for University of Catania and AISM/FISM, Fondazione Italiana Sclerosi Multipla.
Ivana Vodopivec, MD (F Hoffmann-La Roche AG) Dr. Vodopivec has received personal compensation for serving as an employee of Roche. An immediate family member of Dr. Vodopivec has received personal compensation for serving as an employee of Novartis. Dr. Vodopivec has stock in Roche.
Kathleen Blondeau, PhD (Roche) Dr. Blondeau has received personal compensation for serving as an employee of F. Hoffmann-La Roche.
Gaelle Klingelschmitt Gaelle Klingelschmitt has received personal compensation for serving as an employee of F.Hoffmann-La Roche LTD.
Carole Marcillat Carole Marcillat has received personal compensation for serving as an employee of Hoffmann La Roche.
Benjamin M. Greenberg, MD, FAAN (UT Southwestern Medical Center) Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Greenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Horizon. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi/Genzyme. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech/ROche. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Signant. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IQVIA. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer. Dr. Greenberg has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Clene. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cycle Pharma. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for IQVIA. Dr. Greenberg has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Siegel Rare Neuroimmune Association. Dr. Greenberg has stock in GenrAb. Dr. Greenberg has stock in Clene. The institution of Dr. Greenberg has received research support from CLENE Nanomedicine. The institution of Dr. Greenberg has received research support from Anokion. The institution of Dr. Greenberg has received research support from Regeneron. Dr. Greenberg has received intellectual property interests from a discovery or technology relating to health care. Dr. Greenberg has received publishing royalties from a publication relating to health care.