P056 Real life experience with the use of tofacitinib in ulcerative colitis in Colombia: case series.

Background: Tofacitinib is a molecule that inhibits Janus kinases, enzymes involved ulcerative colitis (UC) pathogenesis. This drug has recently been approved by INVIMA (abbreviation in Spanish of National Institute of Food and Drug Surveillance) in Colombia.

Objective: to describe real-life experience in Colombian patients with a diagnosis of UC treated with tofacitinib since its approval.

Methods: Case series of 6 patients diagnosed with UC with moderate-severe activity defined by the American College of Gastroenterology Ulcerative Colitis Activity Index (ACG score) treated with tofacitinib 10 mg every 12 hours (BID) in the induction and maintenance phase. The decision to use tofacitinib was based on clinical judgment and patient preference. Response to treatment was evaluated in terms of endoscopic (Mayo score), paraclinical (CRP, ESR, fecal Calprotectin, Hemoglobin) and clinical response (absence of abdominal pain, diarrhea, and rectal bleeding). Additionally, adverse events, steroid use and response to extraintestinal manifestations (EIM) were evaluated.

Results: Four men and two women with an average age of 35.6 years were included. All 6 patients had moderate to severe UC; 5 patients with pancolitis and 1 with left-colitis. The average time of diagnosis was 4.08 years. Four patients had previously failed TNF-inhibitors (3 Adalimumab, 2 Infliximab, 1 Golimumab), and 2 patients had previously failed integrin alpha-4beta7-inhibitor (Vedolizumab). Two patients were naïve to biological therapy. Three patients were at risk of colectomy due to severe disease activity. Three patients presented EIM. During the induction phase, 1 maintained disease activity without response, 5 presented clinical and paraclinical remission, 20% remained in moderate-severe activity, 20% mild activity and 60% in remission, the 3 patients who were at risk of colectomy were ruled out from surgery due to symptom improvement. At the endoscopic level, 3 endoscopic studies were obtained in the end of induction, of which 1 presented a Mayo score 3, and 2 patients with Mayo score 1. For naïve patients to biological therapy, one achieved clinical and paraclinical remission upon induction, the endoscopic response still has not been measured, in the second naive patient, tofacitinib was used in-hospital since he didn't respond to intravenous steroids for 72 hours and there was no availability of infliximab, ruling out other predisposing factors to exacerbation, achieving the discharge with adequate symptoms control and paraclinical findings. Three patients discontinued corticosteroids, and three patients achieved dose reduction. One patient reported and adverse event, none had drug-associated leukopenia, and 3 of them without lipid alteration after induction. All patients resolved their EIM during induction. Only one patient has completed follow-up during maintenance for 26 weeks, which is in clinical, paraclinical and endoscopic remission with a dose of 10 mg BID, 1 patient at 16 weeks decided to suspend the medication due to lack of response and the other 4 patients are in clinical and paraclinical remission but have not completed the 26 weeks of maintenance and have a follow-up appointment pending.

Conclusion: The results of this case report suggest that tofacitinib may be an effective therapeutic alternative in patients with moderate to severe UC and associated extraintestinal manifestations, with a good safety profile.