P1138Evaluating upadacitinib in the treatment of moderate-to-severe active Inflammatory Bowel Disease, a prospective cohort at a tertiary care center in Riyadh, Saudi Arabia

Abstract Background Inflammatory Bowel Disease (IBD) is a chronic, immune-mediated condition characterised by relapsing intestinal inflammation and significant impact on quality of life. Standard therapies may be insufficient for patients with moderate-to-severe disease or those who develop treatment-refractory inflammation. Selective Janus kinase (JAK) inhibition has emerged as an effective therapeutic strategy targeting key inflammatory pathways involved in IBD pathogenesis. This study aims to evaluate the clinical effectiveness and safety of upadacitinib, a selective JAK1 inhibitor, in patients with Ulcerative Colitis (UC) and Crohn’s disease (CD). Methods This prospective cohort study, conducted at King Fahd Medical City, Riyadh (November 2023–2024), assessed the effectiveness and safety of upadacitinib in adults with IBD. Primary outcomes included clinical effectiveness measured using the Lichtiger score and mayo endoscopic score for UC and the Crohn’s Disease Activity Index (CDAI) for CD. Symptoms, general well-being, mucosal healing, and adverse events were assessed. Data were analysed using SPSS to compare baseline characteristics and evaluate longitudinal changes. Results Thirty-three patients were included (22 with UC and 11 with CD). upadacitinib produced marked clinical improvement across both groups within six months. In UC, mean daily stool frequency decreased from 6.75 to 2.10, with notable reductions in nocturnal diarrhoea and abdominal pain. The Lichtiger score improved from 9.45 at baseline to 3.3 at six months. Mucosal healing was observed, with 42.1% achieving a Mayo score of 0 and 31.6% achieving Mayo 1. Overall well-being also improved. In CD, stool frequency declined substantially, abdominal pain resolved in most cases, and general well-being improved. Mean CDAI scores (mean ± SD) improved from 321.91 ± 132.12 at baseline to 118.60 ± 97.79 at three months, followed by 175.60 ± 158.40 at six months. Safety analysis showed that upadacitinib was well tolerated. Dyslipidaemia was the most common adverse event (25% in UC; 9.1% in CD), and one case of shingles occurred. No serious infections, cardiovascular events, or thromboembolic events were identified. Conclusion In conclusion, treatment was effective and well tolerated overall, demonstrating the ability of upadacitinib to induce remission in both subtypes of IBD. References: Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017;389(10080):1756-1770. Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn’s disease. Lancet. 2017;389(10080):1741-1755. Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014;20(1):91-99. Sandborn WJ, Feagan BG, Hanauer SB, et al. Upadacitinib as induction and maintenance therapy for Ulcerative Colitis. N Engl J Med. 2020;382:2163-2176. Conflict of interest: Dr. Alhubayshi, Abrar: No conflict of interest Almuaili, Hesham: No conflict of interest Alghamdi, Ahmed: No conflict of interest Alahmari, Mohammed: No conflict of interest Alshowair, Mishal: No conflict of interest Al Ibrahim, Bashaar: No conflict of interest