Abstract Details

Title Long-term Efficacy of Satralizumab in Aquaporin-4-IgG-seropositive Neuromyelitis Optica Spectrum Disorder (NMOSD): Results from the Open-label Extension Periods of SAkuraSky and SAkuraStar

Topic Autoimmune Neurology

Presentation(s) S25 - Autoimmune Neurology 2: Clinical Trials and Treatment (5:06 PM-5:18 PM)

Poster/Presentation
Number 009

Background

Satralizumab reduced the risk of protocol-defined relapse (PDR) vs placebo in the double-blind periods (DBP) of two phase 3 trials in NMOSD: SAkuraSky (NCT02028884; satralizumab + baseline immunosuppressants [IST]); SAkuraStar (NCT02073279; satralizumab monotherapy).

Objective

To assess the long-term efficacy of satralizumab in patients with aquaporin-4-immunoglobulin-G-seropositive (AQP4-IgG+) NMOSD.

Design/Methods

Following the SAkura DBPs, patients could enter the open-label extension (OLE, satralizumab 120mg Q4W). This analysis included all AQP4-IgG+ patients who received ≥1 dose of satralizumab in the DBP and/or OLE (data cut-off 22 Feb 2021).

PDRs in the DBPs were adjudicated by a Clinical Endpoint Committee; however, PDRs in the OLE were determined by the investigator (iPDRs). We evaluated the annualised iPDR rate (ARR), time to first iPDR, severe iPDR (≥2 point increase in the Expanded Disability Status Scale [EDSS] score), and sustained EDSS worsening (EDSS increase of ≥2, ≥1, or ≥0.5 points for patients with baseline scores of 0, 1–5, or ≥5.5, respectively, confirmed ≥24 weeks post-initial-worsening).

Results

111 AQP4-IgG+ patients were included (SAkuraSky: 49; SAkuraStar: 62). The median (range) duration of satralizumab exposure was 4.4 (0.1-7.0) years in SAkuraSky and 4.0 (0.1-6.0) years in SAkuraStar. The mean (SD) ARR from first satralizumab dose to the cut-off date was 0.21 (0.57) in SAkuraSky and 0.20 (0.64) in SAkuraStar; the ARR remained stable over the course of the studies. At Week 192 (3.7 years), 71% (SAkuraSky) and 73% (SAkuraStar) of satralizumab-treated patients were free from iPDR, 91% (SAkuraSky) and 90% (SAkuraStar) were free from severe iPDR, and 90% (SAkuraSky) and 86% (SAkuraStar) had no sustained worsening of EDSS.

Conclusions

These long-term results demonstrate that the efficacy of satralizumab +/- IST observed in the DBPs is sustained during the OLE. High proportions of patients remained free from relapse, severe relapse, or worsening disability, with a consistently low ARR over more than 3.5 years of satralizumab treatment.

Authors/Disclosures
Jeffrey L. Bennett, MD, PhD, FAAN (University of Colorado School of Medicine) PRESENTER	Dr. Bennett has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Horizon Therapeutics. Dr. Bennett has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion. Dr. Bennett has received personal compensation in the range of $0-$499 for serving as a Consultant for Genentech. Dr. Bennett has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Chugai. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ImCyse. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Beigene. Dr. Bennett has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Bennett has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Bennett has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Pavich. The institution of Dr. Bennett has received research support from Alexion. Dr. Bennett has received intellectual property interests from a discovery or technology relating to health care. Dr. Bennett has received publishing royalties from a publication 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.
Anthony Traboulsee, MD (University of British Columbia)	Dr. Traboulsee has received personal compensation in the range of $500-$4,999 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 $500-$4,999 for serving on a Speakers Bureau for EMD Serono. The institution of Dr. Traboulsee has received research support from Roche. The institution of Dr. Traboulsee has received research support from Genzyme.
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, Mitsubushi, UCB, Roche, Novartis, Amplo, Alexion, Chugai, Sanofi. 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, Chugai. Dr. Palace has stock in Astra Zenica. The institution of Dr. Palace has received research support from Roche, AMPLO, Alexion, UCB,.Meddimune, argenx. Dr. Palace has received intellectual property interests from a discovery or technology relating to health care.
Takashi Yamamura, MD (National Inst of Neuroscience)	Dr. Yamamura has nothing to disclose.
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.
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.
H. C. Von Buedingen, MD, FAAN (F. Hoffmann-La Roche Ltd)	Dr. Von Buedingen has received personal compensation for serving as an employee of F. Hoffmann-La Roche Ltd.. Dr. Von Buedingen has received stock or an ownership interest from F. Hoffmann-La Roche Ltd.
Daniela Stokmaier	Daniela Stokmaier has received personal compensation for serving as an employee of Roche.
Gaelle Klingelschmitt	No disclosure on file