Benjamin Greeberg, MDResults from the combined double-blind and open-label extension periods of the SAkuraSky (NCT02028884) and SAkuraStar (NCT02073279) clinical trials demonstrated that treatment with satralizumab (SA237; Genentech) was well-tolerated and showed a favorable treatment profile in patients with neuromyelitis optica spectrum disorder (NMOSD).1
Research presented at the 2020 Consortium of Multiple Sclerosis Centers (CMSC) Virtual Annual Meeting revealed that rates of adverse events (AEs) and serious AEs were comparable between the satralizumab and placebo groups in the double blind period (AEs: 478.49 vs. 506.51 events per 100 patient years [PYs], respectively; serious AEs: 14.97 vs 17.98 events per 100 PYs, respectively). These results were also found to be consistent in the overall satralizumab treatment (OST) period, which was defined as the combined time between the double-blind and extension periods.
In total, 4 (3.8%) patients in the satralizumab group and 6 (8.1%) in the placebo group withdrew from the study during the double-blind period due to an AE. Additionally, researchers noted that lower rates of infection were found in satralizumab-treated patients compared with placebo (113.04 vs 154.85 events per 100 PYs).
The research, conducted by Benjamin M. Greenberg, MD, pediatric neurologist, University of Texas Southwestern Medical Center, and colleagues, showed that injection-related reaction rates were higher with satralizumab vs placebo in the double-blind period (17.03 vs 8.99 events per 100 PYs).