使用上市后监测数据，这项中期亚组分析调查了 sarilumab 在年轻（<65 岁）和老年（≥65 岁和≥75 岁）类风湿性关节炎患者中的安全性。 sarilumab 在日本于 2018 年 6 月至 2021 年期间入组。对截至 2022 年 1 月 12 日收集的数据进行分析，并监测超过 52 周的药物不良事件。在 972 名可获得数据的患者中，年龄<65 岁、≥65 岁和≥75 岁的患者比例分别为 40.8%、59.2% 和 27.8%，分别。大多数患者 (95.5%) 接受标准 200 mg 剂量的 Sarilumab 作为初始剂量。 24.6%的患者报告了药物不良反应，其中严重事件占6.4%。所有年龄组均无恶性肿瘤且特别关注的药物不良反应发生率低（<65 岁，7.8%；≥65 岁，8.2%；≥75 岁，8.5%）。当按照绝对中性粒细胞计数高于和低于正常下限进行分层时，各年龄组之间严重和非严重感染的发生率没有数值差异。无论年龄如何，类风湿性关节炎患者对 sarilumab 治疗的耐受性良好，没有出现任何症状。本研究报告了新的安全信号。© 日本风湿病学院 2024 年。牛津大学出版社出版。

Using data from a post-marketing surveillance, this interim subgroup analysis investigated the safety of sarilumab in younger (<65 years) and older patients (≥65 and ≥75 years) with rheumatoid arthritis.During this interim analysis, patients who were treated with sarilumab in Japan were enrolled between June 2018-2021. Data collected by 12 January 2022 were analysed, with adverse drug events monitored over 52 weeks.Of 972 patients with available data, proportion of patients aged <65 years, ≥65 years and ≥75 years were 40.8%, 59.2% and 27.8%, respectively. Most patients (95.5%) received the standard 200 mg dose of sarilumab as the initial dose. Adverse drug reactions were reported in 24.6% of patients, with serious events accounting for 6.4% of cases. No malignancy and low incidences of adverse drug reactions of special interest were reported across all age groups (<65 years, 7.8%; ≥65 years, 8.2%; ≥75 years, 8.5%). When stratified by absolute neutrophil count above and below the lower limit of normal, there were no numerical differences in incidences of serious and non-serious infections between age groups.Regardless of age, sarilumab therapy was well tolerated by patients with rheumatoid arthritis, with no new safety signals reported in this study.© Japan College of Rheumatology 2024. Published by Oxford University Press.