旨在评估 5 年来 SELECT-COMPARE 中乌帕替尼与阿达木单抗的安全性和有效性。患有类风湿性关节炎且对甲氨蝶呤反应不足的患者被随机分配接受乌帕替尼 15mg 每日一次、安慰剂或阿达木单抗 40mg 每隔一周一次，所有患者均同时接受甲氨蝶呤治疗。到第 26 周，对随机治疗反应不足的患者获救；仍在服用安慰剂的患者改用 upadacitinib。完成48周双盲期的患者可以进入长期延期。在第 264 周评估安全性和有效性，并在第 192 周分析放射学进展。通过治疗中出现的不良事件 (TEAE) 评估安全性。按随机分组（无反应者插补 (NRI)）或治疗顺序（如观察到的）分析疗效。乌帕替尼与阿达木单抗相比，TEAE 发生率总体相似，但带状疱疹、淋巴细胞减少、肌酸磷酸激酶升高、肝病的发生率在数字上较高和非黑色素瘤皮肤癌报告了 upadacitinib。与阿达木单抗相比，随机接受 upadacitinib 治疗的患者获得临床缓解 (NRI) 的比例更高；临床疾病活动指数缓解 (≤2.8) 和基于 C 反应蛋白的疾病活动评分 <2.6 分别达到 24.6% 和 18.7%（名义 p=0.042）和 31.8% 和 23.2%（名义 p=0.006）。在第 192 周，连续使用 upadacitinib 与阿达木单抗相比，放射学进展数值较低。 upadacitinib 5 年的安全性与 upadacitinib 的已知安全性一致，没有新的安全风险。 5 年时，乌帕替尼的临床反应在数值上高于阿达木单抗。 Upadacitinib 对于长期类风湿性关节炎治疗显示出良好的获益-风险特征。NCT02629159.© 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。英国医学杂志出版。

To assess the safety and efficacy of upadacitinib versus adalimumab from SELECT-COMPARE over 5 years.Patients with rheumatoid arthritis and inadequate response to methotrexate were randomised to receive upadacitinib 15 mg once daily, placebo or adalimumab 40 mg every other week, all with concomitant methotrexate. By week 26, patients with insufficient response to randomised treatment were rescued; patients remaining on placebo switched to upadacitinib. Patients completing the 48-week double-blind period could enter a long-term extension. Safety and efficacy were assessed through week 264, with radiographic progression analysed through week 192. Safety was assessed by treatment-emergent adverse events (TEAEs). Efficacy was analysed by randomised group (non-responder imputation (NRI)) or treatment sequence (as observed).Rates of TEAEs were generally similar with upadacitinib versus adalimumab, although numerically higher rates of herpes zoster, lymphopenia, creatine phosphokinase elevation, hepatic disorder and non-melanoma skin cancer were reported with upadacitinib. Numerically greater proportions of patients randomised to upadacitinib versus adalimumab achieved clinical responses (NRI); Clinical Disease Activity Index remission (≤2.8) and Disease Activity Score based on C reactive protein <2.6 were achieved by 24.6% vs 18.7% (nominal p=0.042) and 31.8% vs 23.2% (nominal p=0.006), respectively. Radiographic progression was numerically lower with continuous upadacitinib versus adalimumab at week 192.The safety profile of upadacitinib through 5 years was consistent with the known safety profile of upadacitinib, with no new safety risks. Clinical responses were numerically higher with upadacitinib versus adalimumab at 5 years. Upadacitinib demonstrates a favourable benefit-risk profile for long-term rheumatoid arthritis treatment.NCT02629159.© 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.