P0866 Upadacitinib improves symptomatic, biochemical, and intestinal ultrasound parameters in active UC patients up to one year after treatment induction – one year interim results from the IBD-DACH study EUROPE

Abstract Background Upadacitinib (UPA), a reversible and selective Janus kinase-inhibitor was approved for the treatment of moderate-severe ulcerative colitis (UC) in 2022 (1). Despite substantial evidence from pivotal trials, multinational, prospective real-world (RW) data remains limited. We report symptomatic, biochemical, and intestinal ultrasound (IUS) data after one year of UPA therapy in a large, multinational RW UC cohort. Methods EUROPE is an ongoing, prospective, non-interventional, multi-country study in active UC patients who initiate UPA therapy. Primary study aim is to assess RW effectiveness and the predictive value of early (IUS) response for outcomes at week 52 (W52). Here, we show symptomatic, biochemical, and IUS results (bowel wall thickness, BWT) at baseline (BL), W8 and W52 of 111 UC patients. Safety data was available for 263 patients ((≥ 1 dose of UPA). Results Here, 111 UC patients (59.5% male, median age 37.6 (28.0 - 49.6) yrs, median disease duration 6.95 (2.36 – 12.65) yrs) with a visit at W52 were included. Of these, 50.5% (n = 56) had pancolitis and 88.3% (n = 98) were advanced therapy experienced. Of note, 39.8% (n = 39) of the latter had been exposed to ≥ 3 biologicals. Patients had signs of active inflammation at BL (median FCal: 727 (263 – 1500) µg/g, median CRP: 6.45 (1.3 – 20.5) mg/L) with BL steroid use in 46.8% of patients (n = 52). At W8 after UPA induction, the rate of patients in symptomatic remission significantly increased from 19.8% (n = 22) at BL to 69.4% (n = 77) at 8W and to 67.6% (n = 75) at W52 (both p < 0.001 vs. BL, fig.1). Fecal calprotectin and CRP decreased until W8 and remained low until W52 (table 1). BWT in the sigmoid colon decreased from median 5 (3.9-6) mm at BL to 3 (2 – 4) mm at W8 and to 2.85 (2 – 3.6) mm at W52. Of note, patients with a BWT ≤ 3mm at W8 demonstrated higher rates of symptomatic remission at W52 vs those with BWT > 3mm (62.0% vs. 38.0%). In 263 patients, 52.9% adverse events were detected (139 events, 60 patients) of which most were non-serious (SAEs: 8.4% (n = 22). One acute myocardial infarction and 8 thromboembolic events were detected (in 6 patients, one event was a pulmonary embolism. Conclusion In this one-year interim analysis of the EUROPE study, UPA treatment in UC was associated with a positive benefit/risk profile including clinical, biochemical, and IUS improvements. Patients achieving BWT normalisation at 8W were more likely to be in symptomatic remission after one year compared to those without BWT normalisation. References 1. Current SmPC Upadacitinib