P0931 Induction treatment with upadacitinib is associated with high rate of clinical response in patients with refractory Inflammatory Bowel Disease

Abstract Background Upadacitinib is an oral selective Janus kinase-1 (JAK1) inhibitor, that has been approved for the treatment of moderate to severe Ulcerative Colitis (UC) and Crohn’s Disease (CD). The recommended induction dose is 45 mg once daily for 8 weeks for UC and 12 weeks for CD, followed, thereafter, by a maintenance dose of 15 mg or 30mg (for patients with refractory, severe or extensive disease). Our study aims to capture the experience of two tertiary centers on upadacitinib use in refractory UC and CD. Methods This is an ongoing, prospective cohort study. Demographic and disease-related data were collected at baseline. Our primary endpoint is clinical response (CR) at the end of induction, defined as >50% decrease in Patient Reported Outcomes (PROs) and secondary endpoints were steroid-free clinical remission (sf-CRem) and treatment persistence. SPSS23 was used for the statistical analysis. Results The baseline characteristics of our patients are presented in Table 1. At drug initiation, 35.4% were receiving concomitant corticosteroids. The induction period has been concluded by 23/26 patients with UC and 17/21 patients with CD, of whom 22 (95.7%) and 13 (76.5%) respectively commenced maintenance treatment. The primary endpoint of CR was achieved by 19 out of 20 (95%) patients with clinically active UC and 11 out of 16 (68.8%) patients with clinically active CD at baseline. Sf-CRem was achieved by 21/23 (91.3%) patients with UC and 13/17 (76.5%) with CD. The majority of patients with either UC (86.4%) or CD (84.6%) commenced maintenance therapy with a 30 mg dose. Adverse events occurred in 22.9% of patients in our cohort, with acne being the most frequently reported (12.5%). One patient (2.1%) experienced herpes simplex infection and two (4.2%) an increase in their lipid levels, requiring initiation of antihyperlipidemic therapy. No serious adverse events have been reported. Conclusion In our cohort of patients with Inflammatory Bowel Disease who were refractory to multiple advanced treatments, upadacitinib has been shown to be an effective and safe therapeutic option for induction of remission. Most patients with medically refractory IBD in our cohort have received increased maintenance Upadacitinib dosage.