Yamamura Takashi, Isobe Noriko, Kawachi Izumi, Nohara Chiyoko, Miyazaki Yusei, Tomita Minami, Tsumuraya Takahiko, Yamashita Katsuhisa, Nakahara Jin, Nakashima Ichiro, Fujihara Kazuo
Department of Immunology, National Institute of Neuroscience, National Center of Neurology and Psychiatry, 4 Chome-1-1 Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan.
Department of Neurology, Neurological Institute, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan.
Neurol Ther. 2024 Oct;13(5):1361-1383. doi: 10.1007/s40120-024-00640-7. Epub 2024 Jul 16.
Satralizumab, an anti-interleukin-6 receptor antibody, is approved in Japan for relapse prevention in neuromyelitis optica spectrum disorder (NMOSD) and is undergoing post-marketing surveillance (PMS) of clinical use. We aimed to describe the real-world safety and effectiveness of satralizumab in Japanese patients with NMOSD.
This is an ongoing PMS (planned completion: February 2027). This 6-month interim analysis assessed the safety and effectiveness of satralizumab in Japanese patients with NMOSD using data collected from August 2020 to July 2021.
Among 570 patients who participated, 523 (91.75%) were female and the mean ± standard deviation (SD) age was 52.4 ± 14.1 years. At baseline, NMOSD expanded disability status scale mean ± SD was 4.19 ± 2.19; 490 (85.96%) patients used glucocorticoids and 277 (48.59%) patients used immunosuppressants concomitantly. Of 570 satralizumab-treated patients, 85 (14.91%) had discontinued satralizumab treatment at 6 months. For the overall adverse drug reactions (ADRs), 76.22 (66.07-87.48) events/100 person-years occurred in 118 (20.70%) patients, and infections occurred in 28 (4.91%) patients. Serious infections occurred in 18 (3.15%) patients, with an event rate of 9.05 (5.80-13.47) events/100 person-years. Of the 24 events of serious infections, respiratory tract infections (29.17%; 7) and urinary tract infections (25.00%; 6) were the most common serious infection events. One fatal ADR (septic shock) suspected to be related to satralizumab was reported. The mean ± SD glucocorticoid dose reduced from 12.28 ± 10.17 mg/day at the index date to 8.11 ± 7.30 mg/day at 6 months. The Kaplan-Meier cumulative relapse-free rate (95% confidence interval) was 94.59% (92.25-96.23) at 6 months.
In this study, satralizumab was found to be safe, well tolerated, and effective in patients with NMOSD in routine clinical practice. The results are consistent with those of previous clinical trials. The safety and effectiveness of satralizumab in Japanese patients with NMOSD will be analyzed over the 6-year surveillance period.
UMIN Clinical Trials Registry, UMIN000041047.
萨特利珠单抗是一种抗白细胞介素-6受体抗体，在日本被批准用于预防视神经脊髓炎谱系障碍（NMOSD）的复发，目前正在对其临床使用进行上市后监测（PMS）。我们旨在描述萨特利珠单抗在日本NMOSD患者中的真实世界安全性和有效性。
这是一项正在进行的PMS（计划完成时间：2027年2月）。这项为期6个月的中期分析使用2020年8月至2021年7月收集的数据，评估了萨特利珠单抗在日本NMOSD患者中的安全性和有效性。
在参与研究的570例患者中，523例（91.75%）为女性，平均年龄±标准差（SD）为52.4±14.1岁。基线时，NMOSD扩展残疾状态量表平均±SD为4.19±2.19；490例（85.96%）患者同时使用糖皮质激素，277例（48.59%）患者同时使用免疫抑制剂。在570例接受萨特利珠单抗治疗的患者中，85例（14.91%）在6个月时停止了萨特利珠单抗治疗。总体药物不良反应（ADR）发生率为每100人年76.22（66.07 - 87.48）次事件，118例（20.70%）患者发生感染。严重感染发生在18例（3.15%）患者中，事件发生率为每100人年9.05（5.80 - 13.47）次事件。在24例严重感染事件中，呼吸道感染（29.17%；7例）和尿路感染（25.00%；6例）是最常见的严重感染事件。报告了1例疑似与萨特利珠单抗相关的致命ADR（感染性休克）。糖皮质激素平均剂量从索引日期的12.28±10.17毫克/天降至6个月时的8.11±7.30毫克/天。6个月时，Kaplan-Meier累积无复发率（95%置信区间）为94.59%（92.25 - 96.23）。
在本研究中，发现萨特利珠单抗在常规临床实践中对NMOSD患者安全、耐受性良好且有效。结果与先前临床试验一致。将在6年监测期内分析萨特利珠单抗在日本NMOSD患者中的安全性和有效性。
UMIN临床试验注册中心，UMIN000041047
