To estimate the efficacy and safety of satralizumab in a prospective population of Chinese patients with AQP4+ NMOSD.
In January 2024, satralizumab was officially included into the healthcare insurance coverage in China However, the scarcity of real-world evidence emphasizing the need for more cohort studies.
Most of patients ( 88.6%, 47/53) were female, with a median age of onset at 49 (range: 18-83)years. The median follow-up time was 6.2 (rang: 0.8-9.5) months. 58.4% (31/53) of patients received immunosuppressants before initiating satralizumab. The mean ARR decreased significantly after treatment (1.49 vs 0.53; p < 0.001). By September 2024, two patients had relapsed at 3.2 months and 7.2 months, respectively. Visual function, including visual acuity and visual field tests, and Optical Coherence Tomography (OCT) scans, is measured every six months. Improvement in visual function was seen in 5 out of 7 patients. No significant differences were found in the median EDSS scores (p = 0.098) or the mRS scores (p = 1). More than a half of patients (56.5%, 30/53) reported adverse events (AEs) during treatment. Mild injection-related reactions occurred in 32% (17/53) of patients . Of 53 patients, 12 (22.6%) had infections, with 1 severe case of community-acquired pneumonia needing hospital care and IV antibiotics.Two patients discontinued treatment—one due to recurrent urinary tract infections and the other due to financial constraints. Serum AQP4-ab are measured every six months, and 38.4% (5/13) of patients reported a decrease in titers after six months of treatment
Satralizumab significantly reduces relapse rates and may improve visual function in patients with AQP4-ab-positive NMOSD.