Abstract Background As a selective Janus kinase 1 inhibitor, upadacitinib (UPA) has demonstrated favorable therapeutic outcomes in inflammatory bowel disease (IBD) following prior treatment failure. However, its real-world treatment paradigm and safety profiles in Chinese patients remain largely uncharacterized. Methods This multicenter, retrospective cohort study, conducted across 30 IBD centers in China, screened 1,962 patients with moderate-to-severe IBD who initiated UPA treatment between January 1, 2023, and June 30, 2025. Data on patient demographics, treatment patterns (including induction, combination therapy, and discontinuation), and adverse events (AEs) were collected. Each AE was characterized by its severity, potential correlation with UPA, and whether it led to discontinuation or temporary interruption. Results The final analysis included 1,095 patients with ≥1 year of follow-up, comprising 714 with Crohn’s disease (CD) and 381 with ulcerative colitis (UC). Treatment discontinuation rates were 13.9% for CD and 19.4% for UC, primarily due to inadequate response (CD: 8.1%; UC: 9.4%), followed by AEs (CD: 3.9%; UC: 4.7%). Regarding safety, any AEs were reported in 39.9% of CD and 32.5% of UC; AEs possibly related to UPA occurred in 25.4% of CD and 23.6% of UC, while severe AEs occurred in 9.2% and 5.5%, respectively. Subgroup analysis revealed comparable AE profiles between elderly (≥60 years) and younger (60 years) patients, with no statistically significant differences (Figure 1). The most common AEs were cutaneous manifestations, anemia, and respiratory reactions in CD; and cutaneous manifestations, dyslipidemia, and hepatic disorders in UC (Table 1). Conclusion This large real-world study provides robust evidence on the treatment pattern and safety profiles of UPA in Chinese patients with IBD. UPA demonstrated a manageable safety profile despite a distinct AE spectrum. Notably, the comparable AE profiles between elderly and younger patients further support its viability across age groups, though continued monitoring remains prudent. Overall, the findings reinforce UPA’s favorable benefit-risk profile as an effective therapeutic alternative after prior therapy failure. References: Not available. Conflict of interest: Dr. Yao, Lingya: No conflict of interest Xu, Yining: No conflict of interest Xia, Wenhao: No conflict of interest Cao, Qian: No conflict of interest
Yao et al. (Thu,) studied this question.