Development of Extra‐Musculoskeletal Manifestations in Upadacitinib‐Treated Patients With Psoriatic Arthritis or Axial Spondyloarthritis

Objective Assess the development of extra‐musculoskeletal manifestations (EMMs) among patients with psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) treated with upadacitinib 15 mg (UPA15). Methods Data (cutoff: 15August2022) from 5 clinical trials in PsA (2), radiographic axSpA (r‐axSpA; previously ankylosing spondylitis) (2), and non‐radiographic 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 (PBO), UPA15, or adalimumab (ADA; PsA only) and are reported as exposure‐adjusted event rates (events/100 patient‐years [E/100 PY]). Results 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 UPA15 and ADA. In r‐axSpA, development of uveitis was numerically lower (E/100 PY) in patients treated with UPA15 (2.8) versus PBO (7.5) and in patients with no history of uveitis (UPA15: 0.6; PBO: 1.2) versus a history (UPA15: 2.1; PBO: 6.2); occurrence of IBD and psoriasis were low regardless of treatment or prior history. In nr‐axSpA, development of uveitis was low regardless of history, but was numerically lower in patients treated with UPA15 (0.9) versus PBO (2.1); occurrence of IBD and psoriasis were low/absent. Conclusion In patients with spondyloarthritis, development of EMMs was generally low with UPA15. Uveitis was numerically lower in patients treated with UPA15 versus PBO, and particularly in r‐axSpA. Regardless of treatment in r‐axSpA, having a history of uveitis appeared to predispose patients for future uveitis events. image