Tofacitinib for Biologic-Experienced Hospitalized Patients with Acute Severe Ulcerative Colitis: A Retrospective Case-Control Study.

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Despite rescue therapy, more than 30% of patients with acute severe ulcerative colitis (ASUC) require colectomy. Tofacitinib is a rapidly acting JAK inhibitor with proven efficacy in ulcerative colitis. Tofacitinib may provide additional means for preventing colectomy in patients with ASUC.A retrospective case-control study was performed evaluating the efficacy of tofacitinib induction in biologic-experienced patients admitted with ASUC requiring IV corticosteroids. Tofacitinib patients were matched 1:3 to controls according to gender and date of admission. Using Cox regression adjusted for disease severity, we estimated the 90-day risk of colectomy. Rates of complications and steroid dependence were examined as secondary outcomes.Forty patients who received tofacitinib were matched 1:3 to controls (n=113). Tofacitinib was protective against colectomy at 90 days compared to matched controls (HR 0.28, 95% CI 0.10, 0.81, P = 0.018). When stratifying according to treatment dose, 10mg three times daily (HR 0.11 95% CI 0.02, 0.56, P=0.008) was protective, while 10mg twice daily was not significantly protective (HR 0.66, 95% CI 0.21, 2.09, P=0.5). Rate of complications and steroid dependence were similar between tofacitinib and controls.Tofacitinib with concomitant IV corticosteroids may be an effective induction strategy in biologic-experienced patients hospitalized with ASUC. Prospective trials are needed to identify the safety, optimal dose, frequency, and duration of tofacitinib for ASUC.

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Authors: Jeffrey A Berinstein, Jessica Sheehan, Michael Dias, Elliot M Berinstein, Calen A Steiner, Laura A Johnson, Randolph E Regal, John I Allen, Kelly C Cushing, Ryan W Stidham, Shrinivas Bishu, Jami A R Kinnucan, Shirley A Cohen-Mekelburg, Akbar K Waljee, Peter D R Higgins


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