Real-Life Experience of Tofacitinib in Colombian Patients With Severe Acute Ulcerative Colitis: An Observational Study

Background: Severe acute ulcerative colitis (UC) is a medical emergency, which requires rapid and effective treatment, affects up to 25% of patients with UC and is an important cause of morbidity and mortality, involving high risk of colectomy, requiring surgery in 20% during the first admission, increasing to 40% in the second admission tofacitinib is indicated in patients with moderate to severe ulcerative colitis (UC), however, given its rapid onset of action, it may constitute an alternative in patients with severe acute UC hospitalized. There are few data on this indication in the literature. The aim of this study was to describe the efficacy and safety of tofacitinib in the management of patients with hospitalized UC, as well as its clinical characteristics and other treatment patterns. Methods: Descriptive observational study, by convenience sampling, in patients with severe acute UC, both adults and pediatric, who were hospitalized between August 2019 and March 2023 in different Inflammatory Bowel Disease (IBD) referral centers of Gastroenterology, in different cities of Colombia. Sociodemographic and clinical variables were collected, therapeutic response was evaluated in different periods of time and descriptive analysis of quantitative and qualitative variables was performed. Results: Six adults and one pediatric patient. Of which 1/7 were female, median age 32,42 years (range 15-46). All had severe acute UC, with severe symptoms and elevated biochemical markers; 5/7 patients had pancolitis and 2/7 had left colitis. The mean time between UC diagnosis and tofacitinib initiation was 32,1 (SD 26,4 ) months (range 0- 74,2). For induction, 57,14% patients received tofacitinib 10 mg BID, two patients received 10 mg TID for 3 days followed by 10 mg BID, and one patient (pediatric age) received 5 mg BID. 4 patients were managed with infliximab, 2 of them had been managed with infliximab, and the other 2 without response to the first induction dose. The mean time between admission and initiation of tofacitinib in those patients who received sequential corticosteroids and IFX was 8 (SD 2,8) days and that of patients who received only corticosteroids prior to tofacitinib administration was 3 (SD 2,42) days. Clinical improvement was observed in all subjects by day 7 after initiation of tofacitinib. All patients at the end of the induction phase achieved clinical and biochemical remission. During the 6-month maintenance phase, information was obtained from 4 patients, all of whom reported clinical, biochemical and endoscopic remission. In the case of the pediatric patient, clinical improvement was achieved one week after initiating tofacitinib, and at 6 months clinical, biochemical and endoscopic remission was achieved. No serious adverse events were reported in any of the cases. Conclusions: Tofacitinib is an alternative rescue therapeutic option, both in patients with therapeutic failure to anti-TNF and in those cases in which it is not possible to place anti-TNF due to unavailability of the drug, leading to a rapid clinical response, adequate tolerance and less need for colectomy. Prospective randomized studies and comparative efficacy studies are required to determine the optimal dose and outcomes over longer periods of time than currently described.