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利妥昔单抗治疗后,萨特利珠单抗治疗水通道蛋白4-IgG血清阳性视神经脊髓炎谱系障碍患者:病例系列

Satralizumab treatment in patients with AQP4-IgG-seropositive neuromyelitis optica spectrum disorder after rituximab treatment: A case series.

作者信息

Abboud Hesham, Steingo Brian, Vargas Diana, Patel Julie, Nealon Nancy, Willis Mary Alissa, Mao-Draayer Yang, Khaitov Dmitry, Tsai Michelle, Kim Angie, Pandey Krupa, Levy Michael, Molazadeh Negar, Romero Rebecca S, Ferayorni Lisa, Gholizadeh Shervin

机构信息

University Hospitals Cleveland Medical Center, Cleveland, OH, USA.

Infinity Clinical Research, Sunrise, FL, USA.

出版信息

J Neuroimmunol. 2025 Jun 15;403:578585. doi: 10.1016/j.jneuroim.2025.578585. Epub 2025 Mar 16.

Abstract

BACKGROUND

The US Food and Drug Administration approved satralizumab for use in adult patients with aquaporin-4 immunoglobulin G-positive (AQP4-IgG+) neuromyelitis optica spectrum disorder (NMOSD) in 2020, but real-world data are limited. The objective of this case series is to describe the experience with satralizumab in adult patients with AQP4-IgG+ NMOSD who previously received rituximab.

METHODS

Case information for patients with AQP4-IgG+ NMOSD who had received satralizumab for ≥6 months was obtained from US healthcare providers from April 1, 2022, to September 30, 2023. Patient characteristics, examination findings, diagnostic tests, treatment response and adverse events were recorded. Patients who received satralizumab after discontinuing treatment with rituximab were included in this case series.

RESULTS

Twenty patients were included, and their ages ranged from 19 to 70 years. Overall, 45 % of patients self-identified as Black/African American, 40 % as White, 10 % as Asian and 5 % as multiracial. Time since confirmed NMOSD diagnosis ranged from 4 to 17 years. Median (range) duration of rituximab treatment was 50 (12-162) months. The main reasons for switching to satralizumab were intolerance (60 %) to and inadequate disease control (25 %) with rituximab. The majority of patients (70 %) received satralizumab for ≥24 months and as monotherapy (90 %). All 20 patients were free from radiographically confirmed relapses with satralizumab. Overall, patients maintained disease control with satralizumab, and adverse events primarily included asymptomatic laboratory abnormalities. Two patients permanently discontinued satralizumab due to adverse events.

CONCLUSIONS

In this retrospective case series, satralizumab was effective and well tolerated in patients with NMOSD who switched due to ineffectiveness and/or poor tolerability of rituximab. These outcomes align with the long-term efficacy and safety outcomes with satralizumab in the Phase III SAkura clinical trials.

摘要

背景

美国食品药品监督管理局于2020年批准萨特利珠单抗用于治疗水通道蛋白4免疫球蛋白G阳性(AQP4-IgG+)的成年视神经脊髓炎谱系障碍(NMOSD)患者,但真实世界的数据有限。本病例系列的目的是描述萨特利珠单抗在先前接受过利妥昔单抗治疗的AQP4-IgG+成年NMOSD患者中的应用经验。

方法

2022年4月1日至2023年9月30日期间,从美国医疗服务提供者处获取接受萨特利珠单抗治疗≥6个月的AQP4-IgG+ NMOSD患者的病例信息。记录患者的特征、检查结果、诊断测试、治疗反应和不良事件。本病例系列纳入了在停用利妥昔单抗后接受萨特利珠单抗治疗的患者。

结果

共纳入20例患者,年龄在19至70岁之间。总体而言,45%的患者自我认定为黑人/非裔美国人,40%为白人,10%为亚洲人,5%为多种族。确诊NMOSD后的时间范围为4至17年。利妥昔单抗治疗的中位(范围)持续时间为50(12 - 162)个月。改用萨特利珠单抗的主要原因是对利妥昔单抗不耐受(60%)和疾病控制不佳(25%)。大多数患者(70%)接受萨特利珠单抗治疗≥24个月,且为单药治疗(90%)。所有20例患者在接受萨特利珠单抗治疗期间均无影像学证实的复发。总体而言,患者使用萨特利珠单抗维持了疾病控制,不良事件主要包括无症状的实验室异常。两名患者因不良事件永久停用了萨特利珠单抗。

结论

在这个回顾性病例系列中,萨特利珠单抗在因利妥昔单抗无效和/或耐受性差而换药的NMOSD患者中有效且耐受性良好。这些结果与萨特利珠单抗在III期SAkura临床试验中的长期疗效和安全性结果一致。

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