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Case Reports
. 2019 Apr;17(5):988-990.e1.
doi: 10.1016/j.cgh.2018.11.022. Epub 2018 Nov 17.

Efficacy of Induction Therapy With High-Intensity Tofacitinib in 4 Patients With Acute Severe Ulcerative Colitis

Affiliations
Case Reports

Efficacy of Induction Therapy With High-Intensity Tofacitinib in 4 Patients With Acute Severe Ulcerative Colitis

Jeffrey A Berinstein et al. Clin Gastroenterol Hepatol. 2019 Apr.

Abstract

As many as 25% of patients diagnosed with ulcerative colitis are hospitalized with an episode of acute severe ulcerative colitis (ASUC).1 The standard of care for patients hospitalized with ASUC relies on rapid induction with intravenous (IV) corticosteroids. Up to 30% of patients do not respond to corticosteroids alone.2 Rescue therapy with infliximab or cyclosporine has been shown to reduce rates of colectomy to 20% by 90 days.3,4 This still represents a significant rate of treatment failure, which leads to an unplanned and irreversible surgery. In recent years, increasing numbers of patients admitted with ASUC have already failed infliximab therapy, highlighting the need for additional treatment options for these patients. Tofacitinib is a rapidly acting, oral, small-molecule Janus kinase inhibitor that was recently approved by the Food and Drug Administration for treatment of ulcerative colitis.5 We present the first reported use of off-label, high-intensity tofacitinib in 4 patients admitted to our institution with ASUC predicted to fail medical management.

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Conflict of interest statement

Conflicts of interest

These authors disclosure the following: Jami A. R. Kinnucan serves on advisory boards for Janssen, AbbVie, and Pfizer. Peter D. R. Higgins received consulting fees from AbbVie, Amgen, Genentech, JBR Pharma, and Lycera. The remaining authors disclose no conflicts.

Figures

Figure 1.
Figure 1.
(A–D) Endoscopic appearance of patients before receiving tofacitinib (Image order corresponds to patient order where A, Patient 1; B, Patient 2; C, Patient-3; D, Patient 4). (Right) CRP improvement after initiation of tofacitinib. +Indicates when tofacitinib was initiated. *Indicates when the dose of tofacitinib was reduced.

Comment in

  • Tofacitinib: A Jak of All Trades.
    Burke KE, Ananthakrishnan AN. Burke KE, et al. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1438-1440. doi: 10.1016/j.cgh.2018.12.044. Epub 2019 Jan 6. Clin Gastroenterol Hepatol. 2019. PMID: 30625401 Free PMC article. No abstract available.
  • Tofacitinib Is Safe and Effective When Used in Combination With Infliximab for the Management of Refractory Ulcerative Colitis.
    Gilmore R, Hilley P, Srinivasan A, Choy MC, Grace JA, de Cruz P. Gilmore R, et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1302-1303. doi: 10.1016/j.cgh.2020.07.046. Epub 2020 Nov 26. Clin Gastroenterol Hepatol. 2021. PMID: 33248087 No abstract available.
  • Reply.
    Berinstein JA, Steiner CA, Higgins PDR. Berinstein JA, et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1303-1304. doi: 10.1016/j.cgh.2020.08.023. Epub 2020 Nov 26. Clin Gastroenterol Hepatol. 2021. PMID: 33248182 No abstract available.

References

    1. Dinesen LC, Walsh AJ, Protic MN, et al. The pattern and outcome of acute severe colitis. J Crohns Colitis 2010;4:431–437. - PubMed
    1. Turner D, Walsh CM, Steinhart AH, et al. Response to corticosteroids in severe ulcerative colitis: a systematic review of the literature and a meta-regression. Clin Gastroenterol Hepatol 2007;5:103–110. - PubMed
    1. Laharie D, Bourreille A, Branche J, et al. Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open-label randomised controlled trial. Lancet 2012;380:1909–1915. - PubMed
    1. Gibson DJ, Heetun ZS, Redmond CE, et al. An accelerated infliximab induction regimen reduces the need for early colectomy in patients with acute severe ulcerative colitis. Clin Gastroenterol Hepatol 2015;13:330–335. - PubMed
    1. Sandborn WJ, Su C, Sands BE, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2017;376:1723–1736. - PubMed

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