S1878 Real-World Effectiveness and Safety of Upadacitinib in Ulcerative Colitis: A Multi-Centre Study

Introduction: We aimed to describe the real-world effectiveness and safety of upadacitinib (UPA) in ulcerative colitis (UC). Methods: We retrospectively analyzed an ongoing multi-center cohort in the United States of UC patients who started on UPA for active disease. Primary outcome was clinical remission at 1-year assessed by partial Mayo score (resolution of all UC related symptoms and physician global assessment). Secondary outcomes assessed at week (wk) 8 and 6 months (where applicable) included clinical response (>50% reduction in symptoms utilizing the partial Mayo score), clinical remission, endoscopic response (Mayo endoscopic score ≤1 or absence of erosions/ulcerations) and histological remission (defined as normal or chronic inactive). Descriptive statistics was performed. Adverse events investigated include cardiac events (transient ischemic attack, heart failure, and myocardial infarction), venous thrombus embolism/pulmonary embolism (VTE-PE), and herpes zoster (HZ). Results: 405 patients (396 UC and 9 IBD-undifferentiated) were included with median age at initiation of 37.00 years (range 27-47) and a median disease duration of 7.00 years (range 3-14). 56% were men, 84.4% White, 9% African American. 64.4% had extensive colitis. 356 (87.9%) had induction for 8 weeks while 17 (4.2) had induction for 16 wks and 393 (93%) had an induction dose of 45 mg. Maintenance dosing was mostly 30 mg (90.6%). Median duration of follow up was 403 days (interquartile range, 206-720) with 97 (23.95%) with follow-up at 1 year or beyond. Among the evaluable, clinical remission at 8 wks was 36.4% (116/319), 6 months was 48.1% (25/52) and 1 year was 80.6% (29/36). Endoscopic response at 6 months was 80% (16/20) and at 1 year 64% (9/14). Histologic remission was seen at 6 months in 38% (14/36) and at 1 year in 60% (9/15). Colectomy occurred in 19 patients (4.7%). Adverse events were reported in 12.7% with HZ reported in 5 patients (1.5%). One patient aged 53 years had an episode of TIA after 1 year on UPA at 15 mg, without pre-existing cardiovascular risk factors and the UPA use is ongoing at the same dose. There were no reported episodes of worsening of pre-existing cardiovascular disease. There were also no episodes of DVT/PE reported at last follow up. Conclusion: UPA is effective and safe in a real-world clinical setting. Ongoing recruitment will provide further evidence on long term effectiveness and safety.