This is an observational cohort study based on data from the hospital-based NMOSD registry (Chinese Medical Research Registration Number MR-31-22-008563; ChiCTR2000030651). Between October 2023 (when eculizumab was approved for NMOSD in China) and February 2025, 26 consecutive patients with AQP4-IgG-positive NMOSD received eculizumab, and 9 of them were included in this study.
Study Type
OBSERVATIONAL
Enrollment
9
Eculizumab was administered intravenously at a dosage of 900 mg weekly for four consecutive weeks
Huashan Hospital
Shanghai, Shanghai Municipality, China
The change in disability status measured by the MRC scale score
Measured by the MRC scale score for patients with LETM
Time frame: 0, 1, 2, 3, 4, 8 weeks
The change in disability status
Measured by the best corrected visual acuity (BCVA)
Time frame: 0, 1, 2, 3, 4, 8 weeks
Incidence of AEs and SAEs during eculizumab treatment
dverse events were coded using MedDRA version 27.1. Adverse events were analyzed in the safety analysis population (all patients who received at least one dose of study treatment) in terms of percentage incidence and as rates by exposure time (number of events per 100 patient-years of exposure and the associated 95% CI) to adjust for any differences in duration of exposure. The severity of adverse events was measured by NCI CTCAE version 5.0.
Time frame: 1, 2, 3, 4, 8 weeks
The Change in Expanded Disability Status Scale (EDSS) scores
Measured by Expanded Disability Status Scale (EDSS) scores for the entire cohort.
Time frame: 0, 1, 2, 3, 4, 8 weeks
The Change in Opticospinal Impairment Scale (OSIS) scores
Measured by Opticospinal Impairment Scale (OSIS) for the entire cohort.
Time frame: 0, 1, 2, 3, 4, 8 weeks
The change in Visual Functional System Score (VFSS)
Measured by Visual Functional System Score (VFSS) for patients with ON.
Time frame: 0, 1, 2, 3, 4, 8 weeks
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