The findings mark a breakthrough for patients with MOGAD.Satralizumab reduces the risk of relapse by 68 percent in adults and adolescents with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), as shown in the phase III METEOROID study presented at AAN 2026.
At 48 weeks, 87 percent of patients treated with satralizumab were relapse-free vs 67 percent of those receiving placebo, with onset of response observed as early as 8 weeks (p=0.0025). Treatment effects were generally consistent across subgroups, including age, sex, race, and use of background therapy. [AAN 2026, abstract 006]
Additionally, satralizumab reduced by 66 percent the annualized relapse rate, a key secondary endpoint, vs placebo (p=0.0030).
Optimism in the air
“We use a lot of off-label therapies in MOGAD, but many are expensive. Securing coverage for these off-label therapies for our MOG patients has been a real struggle. This is true across the board,” said Dr Michael Levy, associate professor at Harvard School and Massachusetts General Hospital, Boston, Massachusetts, US, at AAN 2026. “Satralizumab would be the first with proven efficacy, and if approved by the US FDA, would essentially prevent relapses in our MOG population.”
The METEOROID study included adults and adolescents aged 12 years and older with MOGAD. Participants were randomly assigned in a 1:1 ratio to receive subcutaneous satralizumab (at doses of 60 mg, 120 mg, or 180 mg, based on body weight) or placebo at weeks 0, 2, and 4, with subsequent dosing every 4 weeks.
Patients receiving background immunosuppressant therapy at randomization continued their treatment throughout the study. The double-blind period was event-driven and concluded after 28 adjudicated relapses were observed.
Patients who experienced a relapse or completed the double-blind phase were eligible to enter an open-label extension, during which all participants received satralizumab. The primary endpoint of the study was the time to first relapse. If adjudicated as a “true relapse”, the patients would then be enrolled in the open-label extension study.
A “true relapse” was defined as any symptomatic attack of optic neuritis, transverse myelitis, or a brain attack that resulted in neurological disability as confirmed by MRI, showing a new or enhancing T2 lesion.
Secondary endpoints included the annualized relapse rate, the rate of active lesions on MRI across the optic nerves, brain, and spinal cord, the proportion of patients requiring rescue therapy, and the annualized rate of inpatient hospitalizations.
More positive results
For other secondary endpoints, satralizumab resulted in a 79 percent reduction in the annualized rate of active MRI lesions across the optic nerves, brain, and spinal cord, and a 73 percent lower proportion of patients requiring rescue therapy vs placebo (p=0.0026 and p=0.0024, respectively). A 17 percent reduction in the annualized rate of inpatient hospitalizations was also observed with satralizumab, although not statistically significant (p=0.7528).
No new safety signals were reported with satralizumab. Adverse events (AEs) were more frequent with satralizumab and these included injection-related reactions (16 percent), influenza (9 percent), arthralgia (9 percent), back pain (9 percent), sinusitis (7 percent), and diarrhoea (6 percent).
Rates of AEs leading to temporary treatment interruption were low (6 percent with satralizumab and 5 percent with placebo). There was one fatality unrelated to treatment, and none of the serious AEs was treatment-related.
A breakthrough for patients
The findings mark a breakthrough for patients with MOGAD, an autoimmune disease in which the immune system periodically attacks the optic nerves and spinal cord, leading to vision loss, weakness, sensory loss, and bowel or bladder dysfunction.