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Introduction <p>Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune condition driven by aquaporin-4 immunoglobulin G (AQP4-IgG). The current treatment paradigm focuses on mitigating clinical relapses and disability accumulation, leaving the underlying serological activity unaddressed. This study evaluated the capacity of satralizumab to achieve a comprehensive remission, as defined by the Serological, Relapse, and Accumulated-disability Remission (SERA-3) target.</p> Methods <p>In this multicenter, real-world cohort study, patients with NMOSD from three tertiary centers in China initiating satralizumab were enrolled. AQP4-IgG levels were measured at baseline, 6, and 12&#xa0;months. Clinical efficacy [annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS)] and safety were evaluated. Heterogeneity in antibody response was analyzed, and baseline characteristics potentially associated with titer reduction were explored.</p> Results <p>Of the 19 patients who were AQP4-IgG seropositive at baseline, 7 (36.84%) met the strict definition of SERA-3 Complete. Of these, 4 patients achieved seroconversion at month 6 and remained seronegative through month 12, whereas 3 first achieved seroconversion at month 12. An additional 5 (26.32%) showed a reduction in AQP4-IgG titers. Satralizumab treatment was associated with marked clinical benefit. Among 33 patients included in the clinical efficacy analysis, 27 (81.82%) remained relapse-free during follow-up, median ARR decreased from 0.92 (IQR 0.56–1.59) to 0 (IQR 0–0), and EDSS scores remained stable in most patients. Exploratory analyses suggested that patients achieving serological response were older at disease onset (57.42 ± 17.82 versus 42 ± 14.24&#xa0;years, <i>p</i> = 0.039) and had experienced fewer pre-treatment relapses (median 2 versus 5, <i>p</i> = 0.049). Satralizumab was generally well tolerated, including in older patients.</p> Conclusions <p>Our findings support SERA-3 as a potential treatment framework for NMOSD. Satralizumab was associated with attainment of serological, relapse, and disability remission in a substantial proportion of patients, supporting further prospective evaluation of SERA-3 as a hypothesis-generating outcome framework.</p>

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AQP4-IgG Dynamics and Exploratory Assessment of SERA-3 in Neuromyelitis Optica Spectrum Disorder Treated with Satralizumab

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月2日

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  • Miaoxin Yu,
  • Xiang Li,
  • Lei Cui,
  • Jinsong Jiao,
  • Qing Sun,
  • Yeqiong Zhang,
  • Renbin Wang,
  • Dantao Peng,
  • Yang He,
  • Yujuan Jiao,
  • Weihe Zhang

摘要

Introduction

Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune condition driven by aquaporin-4 immunoglobulin G (AQP4-IgG). The current treatment paradigm focuses on mitigating clinical relapses and disability accumulation, leaving the underlying serological activity unaddressed. This study evaluated the capacity of satralizumab to achieve a comprehensive remission, as defined by the Serological, Relapse, and Accumulated-disability Remission (SERA-3) target.

Methods

In this multicenter, real-world cohort study, patients with NMOSD from three tertiary centers in China initiating satralizumab were enrolled. AQP4-IgG levels were measured at baseline, 6, and 12 months. Clinical efficacy [annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS)] and safety were evaluated. Heterogeneity in antibody response was analyzed, and baseline characteristics potentially associated with titer reduction were explored.

Results

Of the 19 patients who were AQP4-IgG seropositive at baseline, 7 (36.84%) met the strict definition of SERA-3 Complete. Of these, 4 patients achieved seroconversion at month 6 and remained seronegative through month 12, whereas 3 first achieved seroconversion at month 12. An additional 5 (26.32%) showed a reduction in AQP4-IgG titers. Satralizumab treatment was associated with marked clinical benefit. Among 33 patients included in the clinical efficacy analysis, 27 (81.82%) remained relapse-free during follow-up, median ARR decreased from 0.92 (IQR 0.56–1.59) to 0 (IQR 0–0), and EDSS scores remained stable in most patients. Exploratory analyses suggested that patients achieving serological response were older at disease onset (57.42 ± 17.82 versus 42 ± 14.24 years, p = 0.039) and had experienced fewer pre-treatment relapses (median 2 versus 5, p = 0.049). Satralizumab was generally well tolerated, including in older patients.

Conclusions

Our findings support SERA-3 as a potential treatment framework for NMOSD. Satralizumab was associated with attainment of serological, relapse, and disability remission in a substantial proportion of patients, supporting further prospective evaluation of SERA-3 as a hypothesis-generating outcome framework.