Results of the SAkuraMoon clinical trial (NCT04660539) demonstrated the long-term safety and efficacy of Enspryng (satralizumab-mwge; Genentech, South San Francisco, CA) treatment in individuals with aquaporin-4 immunoglobulin G-positive (AQP4+) neuromyelitis optica spectrum disorder (NMOSD). These results were published in Neurology Neuroimmunology & Neuroinflammation.

Analysis of the SakuraMoon trail included 166 adults with NMOSD who completed the double-blind and open-label extension phases of the SAkuraSky (NCT02028884) and SAkuraStar (NCT02073279) trials. Participants continued receiving 120 mg subcutaneous Enspryng every 4 weeks in addition to immunosuppressive therapy. Safety analysis included participants who received ≥1 dose of Enspryng during the treatment period (median treatment period, 6.9 years). Researchers compared the rates of adverse events (AEs) and infections (per 100 patient-years [PYs]) of participants from the treatment period vs the double-blind period (DBP).

Key results include the following:

  • Compared with the DBP, participants from the treatment period had a lower rate of AEs (299.4 per 100 PYs; 95% CI, 288.8 to 310.2) and serious AEs (8.1 per 100 PYs; 95% CI, 6.4 to 10).
  • The annualized relapse rate (ARR) for individuals with AQP4+ NMOSD (n=111) was 0.07 (95% CI, 0.05-0.10).
  • At 8.8 years, 67% (95% CI, 56% to 76%) of participants were free from investigator-assessed protocol-defined relapse (iPDR), 89% (95% CI, 80% to 94%) were free from severe iPDR, and 82% (95% CI, 72% to 89%) were free from sustained Expanded Disability Status Scale (EDSS) score worsening.

Source: Bennett JL, Fujihara K, Saiz A, et al. Long-term efficacy and safety of satralizumab in patients with neuromyelitis optica spectrum disorder From the SAkuraMoon open-label extension study. Neurol Neuroimmunol Neuroinflamm. 2025;12(5):e200450. doi:10.1212/NXI.0000000000200450