Gastroenterology Research, ISSN 1918-2805 print, 1918-2813 online, Open Access
Article copyright, the authors; Journal compilation copyright, Gastroenterol Res and Elmer Press Inc
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Original Article

Volume 000, Number 000, October 2025, pages 000-000

Efficacy and Safety of Tofacitinib for Acute Severe Ulcerative Colitis: A Systematic Review and Meta-Analysis

Figures

Figure 1.
Figure 1. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram of study screening and selection.
Figure 2.
Figure 2. Forest plots of 90-day colectomy rates: (a) pooled rate of 90-day colectomy; (b) comparison of 90-day colectomy rates between tofacitinib and control groups. CI: confidence interval; IV: inverse variance; MH: Mantel-Haenszel.
Figure 3.
Figure 3. Forest plots of clinical response: (a) at weeks 12 - 14; (b) at week 52. CI: confidence interval; IV: inverse variance.
Figure 4.
Figure 4. Forest plots of clinical remission: (a) at weeks 12 - 14; (b) at week 52. CI: confidence interval; IV: inverse variance.
Figure 5.
Figure 5. Forest plots of steroid-free clinical remission: (a) at weeks 12 - 14; (b) at week 52. CI: confidence interval; IV: inverse variance.

Tables

Table 1. Baseline Characteristics of Included Studies
 
TrialStudy designCountryPatients, nMean age, yearsMale sex, n (%)Disease extentCriteria for ASUCMayo Endo ScoreFollow-up, weeks
ASUC: acute severe ulcerative colitis; BID: twice daily; IBD: inflammatory bowel disease; Mayo Endo Score: Mayo endoscopic subscore; NA: not available; RCT: randomized controlled trial; TID: three times daily; TNF: tumor necrosis factor.
TACOS, 2024 [11]RCTIndia533729 (54%)Proctitis: 4 (7%)
Left-sided colitis: 35 (66%)
Pancolitis: 14 (26%)		Truelove-Witts criteriaNA12
REASUC, 2024 [17]Retrospective cohort
Multicenter		Europe13NANANAPartial Mayo Score or Lichtiger scoreNA52
Berinstein et al, 2021 [16]Retrospective case-controlUSA403416 (40%)Proctitis: 1 (2.5%)
Left-sided colitis: 8 (20%)
Pancolitis: 31 (77.5%)		Truelove-Witts criteria or severe labs and/or endoscopic diseaseMayo 2: 10 (25%)
Mayo 3: 28 (71%)		12
Uzzan et al, 2021 [19]Retrospective and prospective cohort
Multicenter		France5527.630 (55.5%)Left-sided colitis: 19 (35%)
Pancolitis: 36 (65%)		Hospitalization for a flare-up of the IBDMayo 2: 18 (32%)
Mayo 3: 37 (67%)		52
Resal et al, 2024 [18]Retrospective cohort
Multicenter		Europe, Canada, Israel1063845 (42%)Proctitis: 3 (3%)
Left-sided colitis: 34 (32%)
Pancolitis: 69 (65%)		Truelove-Witts criteriaMedian score of 352
TRIUMPH, 2025 [12]Prospective open-label trial
Multicenter		Canada2442.513 (54%)Left-sided colitis: 2 (8.3%)
Extensive colitis: 4 (16.7%)
Pancolitis: 18 (75%)		Modified Truelove-Witts criteriaMayo 3: 18 (75%)52

 

Table 2. Pharmacological Treatment in the Included Studies
 
TrialGroupTofacitinib dosage (or control)Concomitant therapyPrior anti-TNF exposure, %
BID: twice daily; NA: not available; N/A: not applicable; TID: three times daily; TNF: tumor necrosis factor.
TACOS, 2024 [11]Intervention10 mg TID × 7 days, then 10 mg BIDAll received intravenous hydrocortisone (max 7 days), followed by a prednisolone taper5.6%
ControlPlaceboSame as intervention group3.9%
REASUC, 2024 [17]Intervention10 mg BIDAll had previously failed treatment with methylprednisoloneN/A
ControlInfliximab, cyclosporinSame as the intervention groupN/A
Berinstein et al, 2021 [16]Intervention10 mg BID (40%) OR 10 mg TID (60%) for 3 days, then 10 mg BIDAll methylprednisolone 15 mg every 6 h100%
ControlInfliximab, cyclosporinSame as intervention group38.9%
Uzzan et al, 2021 [19]Intervention5 mg BID (22%) or 10 mg BID (78%)36 (65%) receiving steroids89%
ControlN/AN/AN/A
Resal et al, 2024 [18]Intervention20 mg/d induction, 10 mg/d maintenance52 (49%) Prednisolone/methylprednisolone83.6%
ControlN/AN/AN/A
TRIUMPH, 2025 [12]Intervention10 mg BID for 8 weeks, then maintenance 5 or 10 mg BIDAll received intravenous steroids for 7 days, followed by taper in responders33%
ControlN/AN/AN/A