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

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.

User's guide to JAK inhibitors in inflammatory bowel disease

“…When stratified according to treatment dose, 10 ​mg three times daily (TID) was protective (HR 0.11; 95% CI 0.02–0.56; p ​= ​0.008), whereas 10 ​mg BID was not significantly protective (HR 0.66; 95% CI 0.21–2.09; p ​= ​0.5). Rate of complications and steroid dependence were reportedly similar between tofacitinib and controls ( Berinstein et al., 2021 ). This data corroborates similarly reported case series in which tofacitinib with concomitant intravenous corticosteroids has been shown to be an effective induction strategy in biologic-experienced patients hospitalized with ASUC ( Kotwani et al., 2020 ).…”

Predictors of 90-Day Colectomy in Hospitalized Patients Receiving Infliximab for Acute Severe Ulcerative Colitis at a Tertiary Care Center

“…This overall approach would allow providers to tailor the timing and mechanism of therapy to a patient’s individual health needs. 32,33…”

“…This overall approach would allow providers to tailor the timing and mechanism of therapy to a patient's individual health needs. 32,33 Our corticosteroid failure and infliximab failure prognostic scores developed in this study has several strengths. First, they are easy to use since it only contains four easily and routinely measured dichotomous variables.…”

The Era of Janus Kinase Inhibitors for Inflammatory Bowel Disease Treatment

“…In 2021, Straatmijer et al published a retrospective cohort study that included 36 UC patients who received tofacitinib [15]. The median disease duration was 7 (3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14) years; 89% of the patients had previously failed to respond to anti-TNF treatment and 42% to vedolizumab treatment. The primary outcome also included endoscopic improvement and steroid-free clinical remission at week 52.…”

“…In 2021, Berinstein et al performed a retrospective case-controlled study to evaluate the efficacy of tofacitinib induction in biologically experienced patients hospitalized for acute severe UC requiring intravenous corticosteroids [ 14 ]. Forty patients receiving tofacitinib were matched 1:3 with controls (n = 113).…”