4CPS-183 Multicentre study: evaluation of the effectiveness and safety of upadacitinib in inflammatory bowel disease

<h3>Background and Importance</h3> Upadacitinib is a reversible and selective inhibitor of Janus kinases (JAK) recently indicated for the treatment of active moderate to severe inflammatory bowel disease (IBD) in adults with inadequate response, loss of response, or intolerance to conventional treatments or biological agents. <h3>Aim and Objectives</h3> This study aims to evaluate its effectiveness and safety in ulcerative colitis (UC) and Crohn’s disease (CD). <h3>Material and Methods</h3> Multicentre, observational and retrospective study (December 2022-October 2024). Patients who reached at least week 24 (24W) were included, along with reasons for any treatment discontinuation. Collected variables: sex, age, pathology, prior hospital therapies (biological drugs or other JAK inhibitors), treatment start and end dates, faecal calprotectin (FC), C-reactive protein (CRP), number of bowel movements, presence of blood before and after treatment and adverse reactions. Effectiveness was assessed by the reduction in FC and CRP levels, the number of bowel movements and the disappearance of blood in stools from the start of treatment to 24W. Safety was evaluated based on the occurrence of adverse reactions. Continuous variables were expressed as means (standard deviation) and medians (interquartile range). <h3>Results</h3> A total of 31 patients (68% male) were included, with a median age of 38 years (IQR: 28–46) and a mean follow-up of 43 weeks (SD ±19). 58% of the patients had CD and 42% had UC. The median number of previous treatments was 1.7 (IQR: 1–2,5), and concomitant treatments included glucocorticoids (26%) and azathioprine (9.7%). 93,5% of the patients had a maintaining dose of 30 mg. After 24W, FC decreased from 1141 (IQR: 450–2208) to 679 (IQR: 227–1589) and CRP decreased from 4.6 (IQR: 3.5–10.7) to 2.6 (IQR: 0.9–6.5). The mean daily bowel movements decreased from 5.6 (SD ±3.4) to 4.3 (SD ±3.4), while the presence of blood decreased from 61.3% to 25.8%. Regarding safety, 9.7% of patients (n=3) discontinued treatment, with 33.3% due to pregnancy and 66.6% due to adverse reactions (9.7% acne, 6.4% reactivation of cytomegalovirus, 6.4% thrombosis, 3.2% herpes simplex and 3.2% paraesthesia). <h3>Conclusion and Relevance</h3> Upadacitinib is a novel therapy. In our cohort it has improved overall outcomes for patients with IBD, reducing disease-related parameters and the number of bowel movements. Regarding safety, upadacitinib exhibits management and an expected safety profile. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest