S99 Upadacitinib in the Treatment of Ulcerative Colitis. Initial Real-World Experience From a Tertiary Care Center

Abstract

Background: Upadacitinib is a selective Janus kinase inhibitor approved by the FDA in March 2022 for the treatment of patients with moderate to severe ulcerative colitis (UC) who have had an inadequate response or intolerance to anti-tumor necrosis factor alpha agents (TNF-a). Methods: This single center retrospective cohort study included adult patients (age >18 years) with moderate to severe UC who were prescribed upadacitinib at the Mayo Clinic, Rochester, Minnesota. After obtaining institutional review board approval, we searched the electronic medical record to identify patients with UC who had previously failed therapy with Anti-TNF-a and were subsequently treated with Upadacitinib. The primary outcome was clinical response as described by patient reported outcomes. Outcomes were assessed at patients’ most recent follow-up. We also evaluated for adverse events. Results: A total of 23 UC patients received upadacitinib and were included in this analysis. The median age at diagnosis was 31 years, (range 23-54 years) and 11 patients were males. Prior medications included Azathioprine (n=5), Vedolizumab (n=15) Ustekinumab (n=12) and Tofacitinib (n=7). Pre-treatment endoscopic severity was graded as Mayo 2 in 11 and Mayo 3 in 12 cases. The median pretreatment Calprotectin and serum C-reactive protein (CRP) were 920 mcg/g (range 200-3469) and 13 mg/L (range 3-36) respectively. Post treatment information is available for 17 patients (last follow up: September 15, 2022). Median treatment duration was 84 day (16-334 days). Clinical improvement was observed in 12 (70.5%) patients. Amongst the 5 cases that did not respond, 3 cases had primary sclerosing cholangitis, 1 underwent colectomy and colectomy is being considered in 2 cases. There were no adverse effects reported with Upadacitinib use. Conclusion(s): In a single center cohort of 23 patients with UC refractory to anti-TNF-a, upadacitinib use resulted in clinical improvement in 70% of patients with no adverse events. Further long-term data is being collected.