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. 2021 Oct;19(10):2112-2120.e1.
doi: 10.1016/j.cgh.2021.05.038. Epub 2021 May 25.

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

Jeffrey A Berinstein  1 , Jessica L Sheehan  2 , Michael Dias  2 , Elliot M Berinstein  3 , Calen A Steiner  4 , Laura A Johnson  5 , Randolph E Regal  6 , John I Allen  7 , Kelly C Cushing  4 , Ryan W Stidham  8 , Shrinivas Bishu  4 , Jami A R Kinnucan  4 , Shirley A Cohen-Mekelburg  9 , Akbar K Waljee  10 , Peter D R Higgins  4
Affiliations

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

Jeffrey A Berinstein et al. Clin Gastroenterol Hepatol. 2021 Oct.

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.

Keywords: Colectomy; Tofacitinib; Ulcerative Colitis.

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Figures

Figure 1:
Figure 1:
Patient Flow Diagram
Figure 2:
Figure 2:
Risk of Colectomy at 90 days
Figure 3:
Figure 3:
Risk of Colectomy at 90 days According to Tofacitinib Dosing Frequency
See this image and copyright information in PMC

Comment in

  • Health data for all.
    Madhusoodanan J. Madhusoodanan J. Nature. 2022 May;605(7908):182-183. doi: 10.1038/d41586-022-01205-0. Nature. 2022. PMID: 35505184 No abstract available.

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