P1141Efficacy and safety of upadacitinib for the treatment of moderate to severe Ulcerative Colitis in biologic-naïve patients

Background To assess the rates of clinical response at week 8, biochemical response, steroid-free clinical remission, endoscopic healing and safety outcomes at week 26 with upadacitinib in biologic-naïve patients with moderate to severe Ulcerative Colitis (UC). Methods This was a retrospective analysis of prospectively collected data extracted from the notes of biologic-naïve patients with moderate to severe UC who were treated with upadacitinib during the last year in five Greek IBD centres and who had a follow-up of at least 26 weeks after initiation of treatment. Upadacitinib was administered at a dose of 45 mg once daily for 8 weeks followed by a maintenance dose of 30 mg once daily thereafter. Week-8 clinical response was defined as the reduction in the partial Mayo score by at least 2 points, without concomitant use of any steroid preparation (budesonide, prednis(ol)one, or methylprednisolone). Steroid-free clinical remission at week 26 was defined as a partial Mayo score of ≤ 1 point without concomitant use of any steroid preparation. Biochemical response at week 26 was defined as any reduction in faecal calprotectin or plasma C-reactive protein concentrations compared with their baseline levels. Mucosal healing at week 26 was defined as a Mayo endoscopic subscore of ≤ 1. A safety list of all reported adverse events was recorded. Treatment discontinuation due to adverse events was considered as treatment failure, whereas patients needing escalation of the maintenance dose were also considered as non-responders. Results Overall, 36 patients (21 males), aged (mean ± SD) 31.9 (11.1) years and with a disease duration of (mean ± SD) 5.8 (4.9) years were included. UC was extensive in 21 patients and left-sided in 15. Clinical response was observed in 22 (61.1%) patients at week 8. Biochemical response and steroid-free clinical remission at week 26 were achieved in 25 (69.4%) patients, and endoscopic healing in 19 (52.8%) patients. Adverse events that did not lead to treatment discontinuation occurred in three patients (hyperlipidemia n = 1, elevated liver enzymes n = 1, acne n = 1). Conclusion In this retrospective, real-world ongoing cohort study, upadacitinib demonstrated clinical response at week 8 and steroid-free clinical remission at week 26 in more than 60% of biologic-naïve patients with moderate to severe UC, with a good safety profile. Conflict of interest: Mousourakis, Konstantinos: No conflict of interest Kanellopoulos, Panagiotis: Nothing to declare Kozompoli, Dimitra: No conflict of interest Kalogiros, Georgios: No conflict of interest Agorogianni, Alexandra: No conflict of interest Boumponaris, Alexandros: No conflict of interest Lazou, Dimitra: No conflict of interest Karatzas, Pantelis: No conflict of interest Michalopoulos, George: No conflict of interest Striki, Athanasia: No conflict of interest Gatopoulou, Anthia: No conflict of interest Dimitriadis, Dimitris: No conflict of interest Trimponias, Georgios Dimitrios: No conflict of interest Theodoropoulou, Angeliki: No conflict of interest Viazis, Nikolaos: No conflict of interest