Jeffrey A Berinstein1, Jessica L Sheehan2, Michael Dias2, Elliot M Berinstein3, Calen A Steiner4, Laura A Johnson5, Randolph E Regal6, John I Allen7, Kelly C Cushing4, Ryan W Stidham8, Shrinivas Bishu4, Jami A R Kinnucan4, Shirley A Cohen-Mekelburg9, Akbar K Waljee10, Peter D R Higgins4. 1. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan; Department of Internal Medicine, Michigan Medicine, Ann Arbor, Michigan; Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan. Electronic address: jberinst@med.umich.edu. 2. Department of Internal Medicine, Michigan Medicine, Ann Arbor, Michigan. 3. Department of Medicine, St Joseph Mercy Ann Arbor Hospital, Ypsilanti, Michigan. 4. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan; Department of Internal Medicine, Michigan Medicine, Ann Arbor, Michigan. 5. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan. 6. Department of Pharmacy Services, Michigan Medicine, Ann Arbor, Michigan. 7. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan; Department of Internal Medicine, Michigan Medicine, Ann Arbor, Michigan; Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan. 8. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan; Department of Internal Medicine, Michigan Medicine, Ann Arbor, Michigan; Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan; Michigan Integrated Center for Health Analytics and Medical Prediction (MiCHAMP), Ann Arbor. 9. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan; Department of Internal Medicine, Michigan Medicine, Ann Arbor, Michigan; Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan; VA Center for Clinical Management Research, VA Ann Arbor Health Care System, Ann Arbor, Michigan. 10. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan; Department of Internal Medicine, Michigan Medicine, Ann Arbor, Michigan; Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan; Michigan Integrated Center for Health Analytics and Medical Prediction (MiCHAMP), Ann Arbor; VA Center for Clinical Management Research, VA Ann Arbor Health Care System, Ann Arbor, Michigan.
Abstract
BACKGROUND & AIMS: Despite rescue therapy, more than 30% of patients with acute severe ulcerative colitis (ASUC) require colectomy. Tofacitinib is a rapidly acting Janus kinase inhibitor with proven efficacy in ulcerative colitis. Tofacitinib may provide additional means for preventing colectomy in patients with ASUC. METHODS: A retrospective case-control study was performed evaluating the efficacy of tofacitinib induction in biologic-experienced patients admitted with ASUC requiring intravenous 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. RESULTS: Forty patients who received tofacitinib were matched 1:3 to controls (n = 113). Tofacitinib was protective against colectomy at 90 days compared with matched controls (hazard ratio [HR], 0.28, 95% confidence interval [CI], 0.10-0.81; P = .018). When stratifying according to treatment dose, 10 mg three times daily (HR, 0.11; 95% CI, 0.02-0.56; P = .008) was protective, whereas 10 mg twice daily was not significantly protective (HR, 0.66; 95% CI, 0.21-2.09; P = .5). Rate of complications and steroid dependence were similar between tofacitinib and controls. CONCLUSIONS: Tofacitinib with concomitant intravenous 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.
BACKGROUND & AIMS: Despite rescue therapy, more than 30% of patients with acute severe ulcerative colitis (ASUC) require colectomy. Tofacitinib is a rapidly acting Janus kinase inhibitor with proven efficacy in ulcerative colitis. Tofacitinib may provide additional means for preventing colectomy in patients with ASUC. METHODS: A retrospective case-control study was performed evaluating the efficacy of tofacitinib induction in biologic-experienced patients admitted with ASUC requiring intravenous 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. RESULTS: Forty patients who received tofacitinib were matched 1:3 to controls (n = 113). Tofacitinib was protective against colectomy at 90 days compared with matched controls (hazard ratio [HR], 0.28, 95% confidence interval [CI], 0.10-0.81; P = .018). When stratifying according to treatment dose, 10 mg three times daily (HR, 0.11; 95% CI, 0.02-0.56; P = .008) was protective, whereas 10 mg twice daily was not significantly protective (HR, 0.66; 95% CI, 0.21-2.09; P = .5). Rate of complications and steroid dependence were similar between tofacitinib and controls. CONCLUSIONS: Tofacitinib with concomitant intravenous 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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