Satralizumab Effective Long-Term for Reducing Relapse in AQP4+ NMOSD
Results from a study presented at the 2023 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) showed that satralizumab (Chugai Pharmaceutical Co. Ltd., Tokyo, Japan; Hoffman La-Roche Ltd, Basel, Switzerland) was effective long term at preventing relapses when used as a treatment for aquaporin-4 immunoglobulin G-positive (AQP4+) neuromyelitis optica spectrum disorder (NMOSD) with no changes seen in disability status. Previous studies SAkuraSky (NCT0202884) and SAkuraStar (NCT02073279) established satralizumab therapy to be effective in reducing risk of protocol-defined relapse (PDR) and severe PDR when compared with placebo.
The single-arm, open-label study, SAkuraMoon (NCT04660539) enrolled 106 adult participants with AQP4 + NMOSD who had completed the SAkuraSky and SAkuraStar trials. Participants continued to receive 120 mg of satralizumab every 4 weeks throughout the study period for a median duration of 5 y (0.1-7.9). Researchers evaluated long-term efficacy as a factor of annualized investigator-determined PDR (iPDR) rate (ARR), severe iPDR, time to first iPDR, and sustained worsening of Expanded Disability Status Scale (EDSS) score, which was defined as an increase of no less than 2, 1, or 1.5 points for patients respectively scoring 0, 1-5, or at least 5.5 points at baseline. The overall adjusted ARR was 0.09 (95% CI, 0.06-0.12). A longitudinal assessment of results revealed that ARR did not increase with additional years of treatment. After 4.6 years, 72% (95% CI, 62%-80%) of participants treated with satralizumab experienced no iPDR, while 91% (95% CI, 62%-80%) experienced no severe iPDR, and 85% (95% CI, 75%-91%) experienced no sustained worsening of EDSS.
The study includes researchers from the University of British Columbia, Ruhr University Bochum, John Radcliffe Hospital, Fukushima Medical University School of Medicine, the University of Barcelona, Hoffman-La Roche, and the University of Colorado School of Medicine.