为了更新Filgotinib的长期安全性，即Janus激酶1的优先抑制剂，对中度到重度类风湿关节炎的患者进行了七个试验的数据（NCT01888874，NCT01894516，NCT0188874） 3025308 ）。患者每天接受一次 filgotinib 100 mg 或 200 mg。计算治疗期间出现的不良事件 (TEAE) 的暴露调整发生率 (EAIR)/100 患者暴露年 (PYE)。事后分析评估了年龄 <65 岁和 ≥65 岁的患者。患者 (N=3691) 接受 filgotinib 治疗的中位（最长）时间为 3.8 (8.3) 年 (12 541 PYE)。感兴趣的 TEAE 发生率：严重感染、恶性肿瘤、主要不良心血管事件 (MACE) 和静脉血栓栓塞随着时间的推移保持稳定，并且在剂量之间具有可比性。在总体人群中，观察到 filgotinib 100 mg 与 200 mg 相比，带状疱疹的 EAIR (95% CI)/100 PYE 数值较低（1.1（0.8 至 1.5）与 1.5（1.2 至 1.8））。年龄≥65 岁的患者与<65 岁的患者相比，严重感染、带状疱疹、MACE、恶性肿瘤和全因死亡率的发生率更高。在年龄 ≥ 65 岁的患者中，非黑色素瘤皮肤癌 (NMSC) 的 EAIRs (95% CI)/100 PYE (0.4 (0.1 至 1.1) vs 1.4 (0.8 至 2.2))，不包括 NMSC 的恶性肿瘤 (1.0 (0.5 至 1.9)) ) vs 2.0 (1.3 to 2.9)) 和全因死亡率 (1.3 (0.7 to 2.2) vs 1.6 (1.0 to 2.5)) 在数值上较低，filgotinib 100mg 与 200mg 相比。在总体人群中，感兴趣的 TEAE 是稳定的随着时间的推移，filgotinib 100 mg 和 200 mg 剂量组之间的情况相似（带状疱疹除外）。 ≥65 岁的患者建议恶性肿瘤与全因死亡率之间存在剂量依赖性关系。© 作者（或其雇主）2024。CC BY-NC 允许重复使用。禁止商业再利用。请参阅权利和权限。由 BMJ 代表 EULAR 出版。

To update the long-term safety profile of filgotinib, a Janus kinase-1 preferential inhibitor, in patients with moderate-to-severe rheumatoid arthritis.Data from seven trials were integrated (NCT01888874, NCT01894516, NCT02889796, NCT02873936, NCT02886728, NCT02065700 and NCT03025308). Patients received once-daily filgotinib 100 mg or 200 mg. Exposure-adjusted incidence rates (EAIRs)/100 patient-years of exposure (PYE) were calculated for treatment-emergent adverse events (TEAEs). Post hoc analyses assessed patients aged <65 and ≥65 years.Patients (N=3691) received filgotinib for a median (maximum) of 3.8 (8.3) years (12 541 PYE). Rates of TEAEs of interest: serious infections, malignancies, major adverse cardiovascular events (MACE) and venous thromboembolism were stable over time and comparable between doses. In the overall population, numerically lower EAIR (95% CI)/100 PYE of herpes zoster was observed for filgotinib 100 mg versus 200 mg (1.1 (0.8 to 1.5) vs 1.5 (1.2 to 1.8)). Incidence of serious infections, herpes zoster, MACE, malignancies and all-cause mortality was higher in patients aged ≥65 versus <65 years. In patients aged ≥65 years, EAIRs (95% CI)/100 PYE for non-melanoma skin cancer (NMSC) (0.4 (0.1 to 1.1) vs 1.4 (0.8 to 2.2)), malignancies excluding NMSC (1.0 (0.5 to 1.9) vs 2.0 (1.3 to 2.9)) and all-cause mortality (1.3 (0.7 to 2.2) vs 1.6 (1.0 to 2.5)) were numerically lower for filgotinib 100 mg versus 200 mg.In the overall population, TEAEs of interest were stable over time and similar between filgotinib 100 mg and 200 mg dose groups, except for herpes zoster. A dose-dependent relationship between malignancies and all-cause mortality was suggested in patients ≥65 years old.© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ on behalf of EULAR.