Long-term Safety of Satralizumab in Adults with Aquaporin-4-IgG-seropositive (AQP4-IgG+) Neuromyelitis Optica Spectrum Disorder (NMOSD): Results from SAkuraMoon
Brian Weinshenker1, Michael R. Yeaman2, Jerome de Seze3, Francesco Patti4, Ivana Vodopivec5, Kathleen Blondeau5, Gaëlle Klingelschmitt5, Carole Marcillat5, Benjamin M. Greenberg6, Shervin Gholizadeh7
1University of Virginia, Charlottesville VA, USA, 2Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, and Divisions of Molecular Medicine & Infectious Diseases, Harbor-UCLA Medical Center, Torrance, CA, USA, 3Hôpital de Hautepierre, Strasbourg, France, 4Department of Medical and Surgical Sciences and Advanced Technologies GF Ingrassia and Multiple Sclerosis Center AOU Policlinico "G Rodolico" San Marco, University of Catania, Catania, Italy, 5F. Hoffmann-La Roche Ltd, Basel, Switzerland, 6University of Texas Southwestern Medical Center, Dallas, TX, USA, 7Genentech, Inc., San Francisco, CA, USA
Objective:
To evaluate the long-term safety of satralizumab in adults with AQP4-IgG+ NMOSD.
Background:
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).
Design/Methods:
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.
Results:
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.
Conclusions:
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.