Poddubnyy Denis, Parikh Bhumik, Elewaut Dirk, Navarro-Compán Victoria, Siebert Stefan, Paley Michael, Coombs Derek, Lagunes Ivan, Biljan Ana, Nakasato Priscila, Wung Peter, Lubrano Ennio
University of Toronto, Toronto, Ontario, Canada, and Charité-Universitätsmedizin, Berlin, Germany.
AbbVie, Inc, North Chicago, Illinois.
Arthritis Rheumatol. 2025 May;77(5):536-546. doi: 10.1002/art.43069. Epub 2025 Jan 24.
To assess the development of extramusculoskeletal manifestations (EMMs) among patients with psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) treated with upadacitinib 15 mg.
Data (cutoff: August 15, 2022) from five clinical trials in PsA (2), radiographic axSpA (r-axSpA; previously ankylosing spondylitis) (2), and nonradiographic axSpA (nr-axSpA) (1) were analyzed. Treatment-emergent adverse events of EMMs including uveitis, inflammatory bowel disease (IBD), and psoriasis were assessed in patients treated with placebo, upadacitinib 15 mg, or adalimumab (PsA only) and are reported as exposure-adjusted event rates (events per 100 patient-years [E/100 PY]).
Most patients (87.1%-99.3%) did not have a history of EMMs at baseline. In PsA, development of uveitis and IBD were low regardless of treatment or prior EMM history; rates were similar with upadacitinib 15 mg and adalimumab. In r-axSpA, development of uveitis was numerically lower (E/100 PY) in patients treated with upadacitinib 15 mg (2.8) versus placebo (7.5) and in patients with no history of uveitis (upadacitinib 15 mg 0.6; placebo 1.2) versus a history of uveitis (upadacitinib 15 mg 2.1; placebo 6.2); occurrence of IBD and psoriasis were low regardless of treatment or history. In nr-axSpA, development of uveitis was low regardless of history but was numerically lower in patients treated with upadacitinib 15 mg (0.9) versus placebo (2.1); occurrence of IBD and psoriasis were low or absent.
In patients with spondyloarthritis, development of EMMs was generally low with upadacitinib 15 mg. Uveitis was numerically lower in patients treated with upadacitinib 15 mg versus placebo, and particularly in r-axSpA. Regardless of treatment in r-axSpA, having a history of uveitis appeared to predispose patients for future uveitis events.
评估接受15mg乌帕替尼治疗的银屑病关节炎（PsA）或中轴型脊柱关节炎（axSpA）患者的肌肉骨骼外表现（EMM）的发生情况。
分析了来自PsA（2项）、放射学中轴型脊柱关节炎（r-axSpA，既往为强直性脊柱炎）（2项）和非放射学中轴型脊柱关节炎（nr-axSpA）（1项）五项临床试验的数据（截止日期：2022年8月15日）。对接受安慰剂、15mg乌帕替尼或阿达木单抗（仅用于PsA）治疗的患者中出现的包括葡萄膜炎、炎症性肠病（IBD）和银屑病在内的EMM治疗中出现的不良事件进行评估，并报告为暴露调整后的事件发生率（每100患者年的事件数[E/100 PY]）。
大多数患者（87.1%-99.3%）在基线时无EMM病史。在PsA中，无论治疗情况或既往EMM病史如何，葡萄膜炎和IBD的发生率都较低；15mg乌帕替尼和阿达木单抗的发生率相似。在r-axSpA中，接受15mg乌帕替尼治疗的患者葡萄膜炎的发生率（E/100 PY）在数值上低于安慰剂组（2.8 vs 7.5），无葡萄膜炎病史的患者中也是如此（15mg乌帕替尼组0.6；安慰剂组1.2），而有葡萄膜炎病史的患者中则为（15mg乌帕替尼组2.1；安慰剂组6.2）；无论治疗情况或病史如何，IBD和银屑病的发生率都较低。在nr-axSpA中，无论病史如何，葡萄膜炎的发生率都较低，但接受15mg乌帕替尼治疗的患者在数值上低于安慰剂组（0.9 vs 2.1）；IBD和银屑病的发生率很低或未出现。
在脊柱关节炎患者中，15mg乌帕替尼治疗的EMM发生率总体较低。与安慰剂相比，接受15mg乌帕替尼治疗的患者葡萄膜炎发生率在数值上较低，尤其是在r-axSpA中。在r-axSpA中，无论治疗情况如何，有葡萄膜炎病史的患者似乎更容易发生未来的葡萄膜炎事件。
