site:roche.com 2026 METEOROID satralizumab MOGAD results April 2026
Reading Article
PMID: 38991174
Reading Article
PMID: 42631731
Finding Sources
MOGAD update as of 15 September 2026
Biggest news: Phase III METEOROID trial of satralizumab (Enspryng), an IL-6 receptor blocker, met its primary endpoint for relapse prevention in relapsing MOGAD. Roche reported a 68% lower risk of first relapse versus placebo (HR 0.32; 95% CI 0.15-0.70; p=0.0025). At 48 weeks, 87% on satralizumab versus 67% on placebo were relapse-free. The trial included adults and adolescents aged 12 years and older. Roche trial announcement
US regulatory status: On 10 September 2026, the FDA granted Priority Review to Roche’s application for satralizumab in MOGAD. This means expedited review, not approval yet. If approved, it may become the first specifically approved relapse-prevention treatment for MOGAD in the US. Roche FDA update
What has not changed yet: Acute attacks are still generally treated urgently with high-dose corticosteroids, with plasma exchange and/or IVIG used for severe or treatment-refractory attacks. For long-term prevention, IVIG, rituximab, mycophenolate, azathioprine, and prolonged steroid tapering have largely been based on retrospective evidence and individual patient factors. Satralizumab is promising, but routine use depends on regulatory approval, local access, and specialist judgment.
Diagnosis: MOGAD should not be diagnosed from a positive antibody result alone. It requires a compatible clinical demyelinating event plus appropriately interpreted serum MOG-IgG testing, ideally by a live cell-based assay, while excluding alternatives such as MS and AQP4-positive NMOSD. A 2026 systematic review found the 2023 criteria perform well in broad diagnostic cohorts, but specificity is much lower in cohorts already selected for MOG-IgG positivity, reinforcing the need for clinical context. Lu et al., 2026, PMID 42631731
Relapse prevention after a first event: Not every person has a relapsing course, so preventive immunotherapy after the first attack remains individualized. In the French MOGADOR2 cohort, earlier maintenance therapy was associated with lower relapse risk, but this was observational evidence, not a randomized trial. Deschamps et al., 2024, PMID 38991174
Practical takeaway: If someone has recurrent MOGAD or is deciding on maintenance treatment, this is a useful time to discuss the METEOROID results with a neuroimmunologist. Do not stop or switch current immunotherapy based on this news alone.
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