Abstract Details

Title Satralizumab in Patients with Neuromyelitis Optica Spectrum Disorder and Concomitant Autoimmune Disease

Topic Autoimmune Neurology

Presentation(s) Autoimmune Neurology Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 019

Objective To evaluate the safety and efficacy of satralizumab in neuromyelitis optica spectrum disorder (NMOSD) patients with concomitant autoimmune diseases (CAIDs) from the SAkura studies.

Background NMOSD is frequently associated with one or more CAIDs. The SAkura studies (SAkuraSky and SAkuraStar) enrolled a diverse patient population reflective of real-world practice, including patients with CAIDs. In SAkuraSky (satralizumab in combination with baseline immunosuppressants; NCT02028884) and SAkuraStar (satralizumab monotherapy; NCT02073279), satralizumab showed a reduced risk of relapse versus placebo and had a favorable safety profile.

Design/Methods

This analysis was performed using pooled data from patients with a medical history of CAIDs in the intention-to-treat population of the SAkura studies. The frequency of protocol-defined relapses (PDRs) in each treatment arm was reported. Safety was evaluated in the pooled safety analysis population throughout the double-blind period using adverse event (AE) rates per 100 patient-years (PY).

Results 31 patients with CAIDs were enrolled in the SAkura studies (15 in SAkuraSky and 16 in SAkuraStar); of these patients, 15 received satralizumab and 16 received placebo. The most commonly reported CAIDs were Sjögren’s syndrome (n=9) and systemic lupus erythematosus (n=7). In this CAID cohort, the rate of AEs was comparable with satralizumab versus placebo (707.98 vs 795.88 events/100PY, respectively). The rate of serious AEs was 43.83 events/100PY with satralizumab and 33.16 events/100PY with placebo; the difference between arms was mainly driven by multiple events reported in one patient in SAkuraStar. The rate of infections was 175.31 events/100PY with satralizumab versus 232.13 events/100PY with placebo. The most common AEs in both treatment groups were urinary tract infection and upper respiratory tract infection. Consistent with the primary efficacy analysis, fewer patients experienced a PDR with satralizumab versus placebo (3 [20%] vs 7 [44%]).

Conclusions

Satralizumab was well tolerated in NMOSD patients with CAIDs, with comparable safety and efficacy to the overall SAkura study populations.

Authors/Disclosures
Anthony Traboulsee, MD (University of British Columbia) PRESENTER	Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. The institution of Dr. Traboulsee has received research support from Roche. The institution of Dr. Traboulsee has received research support from Consortium of MS Centers. The institution of Dr. Traboulsee has received research support from MS Canada. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Workshop Chair with Consortium of MS Centers.
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.
Brian G. Weinshenker, MD, FAAN (University of Virginia Health System)	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 UCB Pharmaceuticals. Dr. Weinshenker has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Zenas Pharma. 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.
Jacqueline Palace (John Radcliff Hospital Oxford Univeristy Hospitals Trust)	Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck Serono, Medimmune, Argenx, Janssen, AMgen, UCB, Roche, Novartis, Amplo, Alexion, . Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx, Sanofi. Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Roche, UCB, Alexion, Amgen. Dr. Palace has or had stock in Astra Zenica. The institution of Dr. Palace has received research support from Roche, AMPLO, Alexion, UCB,. argenx, amgen. Dr. Palace has received intellectual property interests from a discovery or technology relating to health care.
Ingo Kleiter	Ingo Kleiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Ingo Kleiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Ingo Kleiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Ingo Kleiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Ingo Kleiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. Ingo Kleiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hexal. Ingo Kleiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon. Ingo Kleiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Almirall.
	No disclosure on file
Daniela Stokmaier	Daniela Stokmaier has received personal compensation for serving as an employee of Roche.
	No disclosure on file
Kazuo Fujihara, MD (Tohoku University, School of Medicine)	Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck Boipharma. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Japan Tobacco. Dr. Fujihara has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Fujihara has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mitsubishi-Tanabe. Dr. Fujihara has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Chugai/Roche. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Fujihara 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. Dr. Fujihara has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. The institution of Dr. Fujihara has received research support from Ministry of Health, Welfare and Labor of Japan. Dr. Fujihara has received personal compensation in the range of $10,000-$49,999 for serving as a speaker, chair, etc with Novartis. Dr. Fujihara has received personal compensation in the range of $5,000-$9,999 for serving as a speaker, chair, etc with Biogen. Dr. Fujihara has received personal compensation in the range of $10,000-$49,999 for serving as a speaker, chair, etc with Mitsubishi-Tanabe. Dr. Fujihara has received personal compensation in the range of $10,000-$49,999 for serving as a apeaker, chair, etc with Chugai/Roche. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a speaker, chair, etc with Alexion. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a chair, speaker with Asahi Kasei Medical. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a speaker with Eisai. Dr. Fujihara has received personal compensation in the range of $500-$4,999 for serving as a speaker, chair with Teijin.
Takashi Yamamura, MD (National Inst of Neuroscience)	Dr. Yamamura has nothing to disclose.

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