Satralizumab (Enspryng) significantly reduced the risk of relapse in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), according to research presented at the American Academy of Neurology (AAN) 2026 Annual Meeting.
“METEOROID is the first prospective randomized controlled study in MOGAD and is currently the only study with positive results,” said lead investigator Michael Levy, MD, PhD, Associate Professor of Neurology at Massachusetts General Hospital and Research Director of the Division of Neuroimmunology & Neuroinfectious Disease, who presented the findings at the meeting.
Study participants who received satralizumab had a 68% reduced risk for a new MOGAD relapse as compared with those in the placebo arm. A greater percentage of the cohort also remained relapse-free at 48 weeks. The proportion of relapse-free patients at 48 weeks was 87.3% versus 66.5% (satralizumab vs placebo). Levy noted that efficacy was consistent across all subgroups.
MOGAD is a neurological, immune-mediated demyelinating disorder of the central nervous system, causing inflammation that may result in damage to the optic nerve, spinal cord, brain and/or brainstem. Myelin oligodendrocyte glycoprotein (MOG) is a protein that covers the nerves in the central nervous system. Even though the precise function of MOG remains unclear, it likely plays a role in myelin maturation, myelin integrity, and cell surface interactions. In MOGAD, the immune system attacks the MOG protein found on the myelin covering of nerves.
"The most common sites of attack are the optic nerves, spinal cord, and the brain, especially in children," Levy said. "These attacks tend to be severe, leading to hospitalization, and the diagnosis is confirmed upon positive serology for the MOG antibody. There are currently no approved therapies.”
Relapsed disease is characterized by multiple and unpredictable attacks of worsening neurological symptoms. Following an attack, symptoms don’t always completely resolve, and may result in further neurological damage, vision loss, and disability.
Satralizumab is a monoclonal antibody that targets the interleukin-6 (IL-6), and received FDA approval in 2020 for the treatment of aquaporin-4 seropositive neuromyelitis optica spectrum disorder. IL-6 is hypothesized to play a role in the pathogenesis of MOGAD, Levy explained.
In the METEOROID study, Levy and colleagues evaluated the efficacy and safety of satralizumab for the treatment of MOGAD. A total of 132 patients were randomized to receive either satralizumab (n=68) or placebo (n=64). All patients in the study had experienced one or more relapses in the last 12 months or two or more attacks in the last 24 months. Satralizumab was administered subcutaneously at Weeks 0, 2, 4 and every four weeks after that.
The primary endpoint was time to first relapse, and key secondary endpoints evaluated relapse rate, active MRI lesions, need for rescue therapy and hospitalization, and safety.
If the first relapse was adjudicated as a true relapse, “that would then bump the patient to the open-label extension study,” Levy explained. “This ensured that patients would not suffer more than one relapse in the double-blind period."
Satralizumab treatment prolonged the time to first relapse versus placebo, resulting in a 68% reduction in the risk of a new MOGAD relapse (hazard ratio: 0.32; p=0.0025). By the second year, only 15.7% of patients in the satralizumab arm relapsed, while 84.3% remained in remission.
For the key secondary endpoints, satralizumab treatment reduced the annualized rate of adjudicated relapses by 66.3%, the annualized rate of active lesions by 78.5%, and the proportion of participants receiving rescue therapy by 72.5%, versus placebo. But satralizumab treatment did not prove superior to placebo when it came to preventing being hospitalized. For the annualized rate of hospitalizations, there were no significant differences between groups.
Levy noted that satralizumab was well tolerated and the safety data observed was consistent with the known safety profile. The number of adverse events was similar in both arms.
“There is a need for effective long-term relapse prevention therapies with an acceptable safety profile for chronic use as no approved therapies exist,” he concluded. “METEOROID provides the first positive Phase 3 data in treating this disease.”
The open-label extension study is ongoing, and the manufacturer plans to submit the METEOROID data to the FDA later this year.
PL5: Clinical Trials Plenary Session
Safety and Efficacy of Satralizumab in Patients with Relapsing Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD): Results from the Phase 3 METEOROID Trial"
The METEOROID study was supported by Genentech/Roche. Levy reported receiving both personal compensation and research support from the National Institutes of Health, Genzyme, Alexion, Alnylam, Shire, Acorda, Genentech/Roche, Horizon, Quest Diagnostics, UCB, and Sanofi.
Image by S-S-S / Getty Images
