Abstract Details

Title Long-term Efficacy of Satralizumab in Patients with Aquaporin-4-IgG-seropositive (AQP4-IgG+) Neuromyelitis Optica Spectrum Disorder (NMOSD): Updated Analysis from the Open-label SAkuraMoon Study

Topic Autoimmune Neurology

Presentation(s) S32 - Autoimmune Neurology: NMOSD/MOGAD (1:12 PM-1:24 PM)

Poster/Presentation
Number 002

Background

Satralizumab significantly reduced the risk of protocol-defined relapse (PDR) in two pivotal Phase 3 trials in patients with NMOSD: SAkuraSky (NCT02028884; satralizumab + baseline immunosuppressants [IST]) and SAkuraStar (NCT02073279; satralizumab monotherapy).

Objective To assess the long-term efficacy of satralizumab in patients with AQP4-IgG+ NMOSD.

Design/Methods Patients who completed the double-blind periods (DBPs) and open-label extensions (OLEs) of SAkuraSky and SAkuraStar were rolled-over into SAkuraMoon (NCT04660539) and continued receiving satralizumab 120mg Q4W ± IST. Efficacy analyses were based on the overall satralizumab treatment period; patients who received ≥1 dose of satralizumab during the SAkuraSky and SAkuraStar studies (data cut-off: 31 January 2023). PDRs were adjudicated by a Clinical Endpoint Committee in the DBPs and were determined by the investigator (iPDRs) in the OLEs and SAkuraMoon. Annualized iPDR rate (ARR), time to first iPDR, severe iPDR (≥2 point increase in 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) were analyzed.

Results

Overall, 111 AQP4-IgG+ patients were included. The median (range) duration of satralizumab exposure was 5.9 (0.1–8.9) years. The overall adjusted ARR (95% CI) was 0.08 (0.06–0.10), where the ARR did not increase with additional years of exposure (Y1: 0.17 [0.10–0.28]; Y2: 0.10 [0.05–0.19]; Y3: 0.04 [0.01–0.14]; Y4: 0.08 [0.02–0.25]; Y5: 0.05 [0.01–0.17]). At Week 288 (5.5 years), 72% (95% CI: 62–80%) of satralizumab-treated patients were free from iPDR, 91% (83–95%) were free from severe iPDR, and 83% (74–90%) had no sustained EDSS worsening. Three patients discontinued SAkuraMoon (switch to commercial satralizumab, n=2; pregnancy, n=1).

Conclusions

These results demonstrate the effective long-term management of NMOSD with satralizumab over 5.5 years of treatment. The ARR remained consistently low in satralizumab-treated patients, with high proportions of patients remaining free from relapse, severe relapse, and worsening disability.

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.
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.
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.
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.
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.
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.
Daniela Stokmaier	Daniela Stokmaier has received personal compensation for serving as an employee of Roche.
Gaelle Klingelschmitt	No disclosure on file
Audrey Yeo	No disclosure on file
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.
Takashi Yamamura, MD (National Inst of Neuroscience)	Dr. Yamamura has nothing to disclose.