This study aims to evaluate the efficacy and safety of different monoclonal antibody in the acute phase of neuromyelitis optica spectrum disorder (MAAP-NMO). It will also examine immune-related biomarkers and their relationship with treatment response to provide evidence for optimizing acute-phase therapeutic strategies.
Age at onset ≥18 years, any gender.
Patients meeting the 2015 International Panel for NMO Diagnosis (IPND) criteria for NMOSD and currently in the acute phase, defined as new or significantly worsened neurological deficits lasting >24 hours, with onset within <14 days, excluding pseudo-relapses caused by fever, infection, or metabolic disturbances. The acute relapse must meet at least one of the following clinical phenotypes: a) Optic neuritis (ON): EDSS visual function score ≥3; b) Transverse myelitis (TM): EDSS pyramidal function score ≥2. NMOSD-related syndromes (e.g., area postrema syndrome, acute brainstem syndrome, acute diencephalic syndrome, cerebral syndrome) may be present as concomitant features but cannot be the sole or primary manifestation.
Serum AQP4-IgG positive by cell-based assay (CBA) with a titer ≥1:32, and negative for MOG-IgG (CBA or LCBA) and GFAP-IgG.
Expanded Disability Status Scale (EDSS) score at enrollment ≥3 and ≤8 points.
Participation in a randomized clinical trial with blinded treatment allocation.
Received treatment with monoclonal antibody (including rituximab, satralizumab, inebilizumab, eculizumab, efgartigimod, etc.) within 3 months prior to screening.
Received treatment with IVIg, plasma exchange (PE), IVMP, or oral corticosteroids >30 mg/day within 1 month prior to screening.
Incomplete or unavailable follow-up data, expected inability to complete follow-up, or poor compliance.
NMOSD patients with acute attacks
Cohort
Prospective
Not listed
Change in Expanded Disability Status Scale (EDSS) score
Change in Expanded Disability Status Scale (EDSS) score from baseline to 1 months after treatment (EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
Change in Expanded Disability Status Scale (EDSS) score
Change in Expanded Disability Status Scale (EDSS) score from baseline at 3 and 6 months (EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
Percentage of Participants with Improvement
Improvement is defined as: 1. ≥1.0-point decrease from baseline if baseline EDSS ≤5.5; 2. ≥0.5-point decrease from baseline if baseline EDSS \>5.5.
Change in Low-Contrast Visual Acuity (LCVA)
Low-Contrast Visual Acuity (LCVA), using a standardized low-contrast ETDRS visual acuity chart, the number of letters that the patient can identify at a sitting position and a distance of 4 meters / 1 meter is measured to reflect the recovery of visual function.
Percentage of Participants without relapse
Relapse is defined as new neurological symptoms or significant worsening of existing symptoms lasting ≥24 hours during the follow-up period, excluding causes such as infection or fever, and confirmed by imaging or clinical evaluation.
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