Satralizumab Monotherapy for AQP4-IgG+ NMOSD

Participants will be treated with satralizumab 120 mg as monotherapy via subcutaneous injection using a pre-filled syringe at Weeks 0, 2, 4, and then every 4 weeks until the last administration at Week 92. This is consistent with the licensed dosing regimen of satralizumab in AQP4-IgG+ NMOSD (9 , 10 ). The first dose of satralizumab will be administered by the site staff at Week 0. The second dose will be self-administered by participants (or their caregivers) under the supervision of a designated study staff member at the study site at Week 2. If the treating physician is satisfied that the participant (or their caregiver) can perform the injection, all subsequent doses may be administered at home. A telephone interview the working day after each satralizumab dose will confirm compliance, and evaluate any changes in health status (e.g., new or worsening neurological symptoms, or any possible AEs).
Rescue therapy for clinical relapses and pain medications are both permitted during the study. Rescue therapies include pulse intravenous corticosteroids, oral corticosteroids for tapering, intravenous immunoglobulin, and/or apheresis (including plasma exchange [PLEX] and plasmapheresis). Pain medications include, but are not limited to, pregabalin, gabapentin, carbamazepine, clonazepam, duloxetine, and tramadol/acetaminophen. Combination treatment with immunosuppressive therapies (e.g., azathioprine, cyclosporine, methotrexate, mycophenolate mofetil, tacrolimus) is not permitted, even if a relapse occurs.