Higher observed 12-month relapse-free survival with satralizumab than with rituximab in aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder: a multicenter retrospective cohort study
Abstract
BackgroundDirect real-world comparisons of satralizumab and rituximab in aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder remain uncommon.MethodsWe conducted a multicenter retrospective cohort study across eight hospitals in Fujian Province, China. Patients aged 12 years or older contributed treatment episodes beginning at the first verifiable administration of satralizumab or rituximab. Patients who changed therapy could contribute one episode to each treatment group, while uncertainty estimates accounted for patient-level clustering. The primary outcome was time to the first clinician-documented NMOSD relapse. Kaplan–Meier methods estimated 12-month relapse-free survival and its absolute between-treatment difference. Restricted mean relapse-free time, recurrent relapses, treatment-period safety events, and exploratory Expanded Disability Status Scale outcomes were also examined. Sensitivity analyses considered treatment switching, episode selection, calendar era, center composition, age restriction, and propensity-score overlap weighting.ResultsThe cohort included 103 patients and 115 treatment episodes (50 satralizumab and 65 rituximab). First relapse within 12 months occurred in 1 satralizumab episode and 10 rituximab episodes. Twelve-month relapse-free survival was 98.0% (95% CI, 94.2–100.0%) with satralizumab and 84.6% (95% CI, 76.2–93.8%) with rituximab, an absolute difference of 13.44 percentage points (patient-clustered bootstrap 95% CI, 4.20–23.59). The direction was consistent across the principal unweighted sensitivity analyses. Corrected overlap weighting yielded a 5.28-percentage-point difference (95% CI, −11.69 to 21.21); limited common support, an effective rituximab sample size of 9.38, and appreciable patient influence made this an exploratory estimate. Infection rates were 18.2 and 14.7 events per 100 treatment-episode years, respectively (rate ratio, 1.24; 95% CI, 0.58–2.37), and one serious adverse event occurred in each group. Exploratory EDSS analyses did not identify a clear between-group difference.ConclusionsSatralizumab episodes had higher observed 12-month relapse-free survival than rituximab episodes in this cohort. The finding is a clinically relevant real-world comparison signal, while the treatment-specific contribution to the difference remains uncertain because treatment eras were separated, common support was limited, and satralizumab events were sparse.
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BibTeX
@article{lin2026higher,
title = {{Higher observed 12-month relapse-free survival with satralizumab than with rituximab in aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder: a multicenter retrospective cohort study}},
author = {Xiao Lin and Jicheng Zhang and Lei Chen and Meiqun Deng and Keyi Zeng and Hanfei Chen and Qing Lin and Xiulong Jiang and Weihong Zheng and Xiaolan Wei and Jian Zhang and Tianwen Huang and Ying Chen and Jingcong Zhuang and Huili Yang and Hua Ge and Chunnuan Chen and Zhenxin Li and Aiyu Lin},
journal = {Frontiers in Immunology},
year = {2026},
month = nov,
doi = {10.3389/fimmu.2026.1963400},
url = {https://www.frontiersin.org/articles/10.3389/fimmu.2026.1963400},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Higher observed 12-month relapse-free survival with satralizumab than with rituximab in aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder: a multicenter retrospective cohort study
AU - Xiao Lin
AU - Jicheng Zhang
AU - Lei Chen
AU - Meiqun Deng
AU - Keyi Zeng
AU - Hanfei Chen
AU - Qing Lin
AU - Xiulong Jiang
AU - Weihong Zheng
AU - Xiaolan Wei
AU - Jian Zhang
AU - Tianwen Huang
AU - Ying Chen
AU - Jingcong Zhuang
AU - Huili Yang
AU - Hua Ge
AU - Chunnuan Chen
AU - Zhenxin Li
AU - Aiyu Lin
PY - 2026
DA - 2026/11/03
JO - Frontiers in Immunology
DO - 10.3389/fimmu.2026.1963400
UR - https://www.frontiersin.org/articles/10.3389/fimmu.2026.1963400
AB - BackgroundDirect real-world comparisons of satralizumab and rituximab in aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder remain uncommon.MethodsWe conducted a multicenter retrospective cohort study across eight hospitals in Fujian Province, China. Patients aged 12 years or older contributed treatment episodes beginning at the first verifiable administration of satralizumab or rituximab. Patients who changed therapy could contribute one episode to each treatment group, while uncertainty estimates accounted for patient-level clustering. The primary outcome was time to the first clinician-documented NMOSD relapse. Kaplan–Meier methods estimated 12-month relapse-free survival and its absolute between-treatment difference. Restricted mean relapse-free time, recurrent relapses, treatment-period safety events, and exploratory Expanded Disability Status Scale outcomes were also examined. Sensitivity analyses considered treatment switching, episode selection, calendar era, center composition, age restriction, and propensity-score overlap weighting.ResultsThe cohort included 103 patients and 115 treatment episodes (50 satralizumab and 65 rituximab). First relapse within 12 months occurred in 1 satralizumab episode and 10 rituximab episodes. Twelve-month relapse-free survival was 98.0% (95% CI, 94.2–100.0%) with satralizumab and 84.6% (95% CI, 76.2–93.8%) with rituximab, an absolute difference of 13.44 percentage points (patient-clustered bootstrap 95% CI, 4.20–23.59). The direction was consistent across the principal unweighted sensitivity analyses. Corrected overlap weighting yielded a 5.28-percentage-point difference (95% CI, −11.69 to 21.21); limited common support, an effective rituximab sample size of 9.38, and appreciable patient influence made this an exploratory estimate. Infection rates were 18.2 and 14.7 events per 100 treatment-episode years, respectively (rate ratio, 1.24; 95% CI, 0.58–2.37), and one serious adverse event occurred in each group. Exploratory EDSS analyses did not identify a clear between-group difference.ConclusionsSatralizumab episodes had higher observed 12-month relapse-free survival than rituximab episodes in this cohort. The finding is a clinically relevant real-world comparison signal, while the treatment-specific contribution to the difference remains uncertain because treatment eras were separated, common support was limited, and satralizumab events were sparse.
SN - 1664-3224
ER -