Satralizumab Reduces MOGAD Relapse Risk in Phase 3 METEOROID Trial

Satralizumab (Enspryng; Genentech) significantly reduced the risk of relapse compared with placebo in patients with relapsing myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), according to findings from the phase 3 METEOROID trial (NCT05271409). Treatment with the agent, which has previously been approved for neuromyelitis optica spectrum disorder (NMOSD), was associated with a 68% reduction in the risk of a first adjudicated relapse, with 87.3% of patients remaining relapse-free at 48 weeks.

Presented at the 2026 Child Neurology Society (CNS) Annual Meeting, held October 14-17, in Montreal, Canada, the double-blind, placebo-controlled study enrolled 132 patients aged 12 years and older with relapsing MOGAD, with 68 patients assigned to satralizumab and 64 assigned to placebo. Patients received subcutaneous satralizumab or placebo, with or without concomitant immunosuppressive therapy (IST). The findings addressed an unmet treatment need in MOGAD, a demyelinating disease in which attacks can result in substantial neurological and visual disability.

Led by Eoin Flanagan, MB, BCh, professor of neurology and neurologist at Mayo Clinic, and colleagues observedsatralizumab prolonged the time to first adjudicated relapse of 68% compared with placebo, corresponding to a hazard ratio of 0.32 (95% CI, 0.15-0.70; P = .0025). The proportion of patients remaining relapse-free at 48 weeks was 87.3% with satralizumabcompared to 66.5% with placebo, and consistent efficacy was observed across patient subgroups.

Satralizumab also demonstrated benefits across key secondary end points. Treatment was associated with a 66.3% reduction in annualized relapse rate, a 78.5% reduction in the annualized rate of active MRI lesions, and a 72.5% reduction in rescue therapy use compared with placebo. All 3 secondary end points were reported as statistically significant, although additional effect estimates and confidence intervals were not provided in the abstract.

The safety profile of satralizumab was favorable, according to the investigators. Rates of adverse events (AEs) and infections were comparable between treatment groups, while serious AEs were infrequent and were not considered related to treatment. Treatment discontinuation rates were also low.

The METEOROID findings also support the ongoing regulatory review of satralizumab for MOGAD. The FDA granted priority review to Roche/Genentech’s supplemental biologics license application for satralizumab, positioning the therapy as a potential first FDA-approved treatment for the condition, which currently has no approved disease-modifying therapies. As of now, the FDA decision is expected by January 10, 2027.^2,3

Without an approved relapse-prevention therapy specific to MOGAD, clinicians have traditionally relied on off-label immunosuppressive treatments, including rituximab, azathioprine, mycophenolate mofetil, and intravenous immunoglobulin.^2,3

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REFERENCES
1. Flanagan E, Levy M, Kuempfel T, et al. AOP-3 Safety and efficacy of satralizumab in patients with relapsing myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD): Results from the phase 3 METEOROID trial. Presented at: Child Neurology Society (CNS); October 14-17, 2026; Montreal, Canada.
2. U.S. FDA grants priority review for Roche’s Enspryng for MOGAD, an autoimmune disease with no approved treatments. News release. September 10, 2026. Accessed September 10, 2026. https://www.globenewswire.com/news-release/2026/09/10/3359176/0/en/u-s-fda-grants-priority-review-for-roche-s-enspryng-for-mogad-an-autoimmune-disease-with-no-approved-treatments.html
3. Genentech’s Enspryng (satralizumab) reduces risk of relapses by 68%, demonstrating potential to become first treatment for MOGAD. News release. April 21, 2026. Accessed September 10, 2026. https://www.gene.com/media/press-releases/15108/2026-04-21/genentechs-enspryng-satralizumab-reduces