Abstract Details

Title Long-term Safety of Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD): Results from the Phase 3 SAkuraSky and SAkuraStar Studies

Topic Autoimmune Neurology

Presentation(s) S25 - Autoimmune Neurology 2: Clinical Trials and Treatment (5:18 PM-5:30 PM)

Poster/Presentation
Number 010

Background

Satralizumab reduced relapse risk and showed a favorable safety profile vs placebo (PBO) in two pivotal phase 3 trials in pts with NMOSD: SAkuraSky (satralizumab + baseline immunosuppressants [IST]) and SAkuraStar (satralizumab monotherapy).

Objective

To analyze the long-term safety of satralizumab in patients (pts) with NMOSD during the double-blind periods (DBP) and open-label extensions (OLE) of the SAkura studies.

Design/Methods The SAkura studies comprised a DBP followed by an OLE. Satralizumab was administered subcutaneously at Weeks 0, 2, 4, and Q4W thereafter in the DBP and OLE. The overall satralizumab treatment period (OST) comprised all pts who received ≥1 dose of satralizumab in the DBP and/or OLE (cut-off 22 Feb 2021). Safety was evaluated in the DBP and OST, and rates of adverse events (AEs) were reported per 100 patient-years (PY).

Results Median (range) satralizumab exposure in the OST was 4.4 (0.1–7.0) years in SAkuraSky and 4.0 (0.1–6.1) years in SAkuraStar. In the SAkuraSky DBP, 41 pts received satralizumab and 42 PBO; 75 were included in the OST. In the SAkuraStar DBP, 63 pts received satralizumab and 32 PBO; 91 were included in the OST. Rates of AEs (SAkuraSky 365.6 AE/100 PY; SAkuraStar 351.7 AE/100 PY) and serious AEs (SAEs; SAkuraSky 10.4 SAE/100 PY; SAkuraStar 10.9 SAE/100 PY) in the OST were comparable to the DBP. Rates of infection and serious infection with satralizumab in the OST were similar to the DBP and did not increase over time. No deaths or anaphylactic reactions related to satralizumab were reported in either study.

Conclusions The favorable safety profile of satralizumab (± IST) was sustained with long-term treatment over a median treatment exposure of 4 years.

Authors/Disclosures
Benjamin M. Greenberg, MD, FAAN (UT Southwestern Medical Center) PRESENTER	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 $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Greenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. 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 $5,000-$9,999 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 $50,000-$99,999 for serving as a Consultant for Clene. Dr. Greenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. 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 $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abcuro. 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 received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Carlton Fields. Dr. Greenberg has stock in GenrAb. Dr. Greenberg has stock in Clene. 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.
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.
Albert Saiz (Hospital Clinico De Barcelona)	Albert Saiz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Albert Saiz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Albert Saiz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Albert Saiz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janseen. Albert Saiz has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Albert Saiz has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for novartis. Albert Saiz has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen.
Takashi Yamamura, MD (National Inst of Neuroscience)	Dr. Yamamura has nothing to disclose.
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.
Carole Marcillat	Carole Marcillat has received personal compensation for serving as an employee of Hoffmann La Roche.
	No disclosure on file
	No disclosure on file
Kathleen Blondeau (Roche)	No disclosure on file
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.
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.