Comparison of Tacrolimus and Infliximab for Acute Severe Ulcerative Colitis in Hospitalized Adults: A Retrospective Study.

OBJECTIVES

Comparative data on infliximab (IFX) and tacrolimus as salvage therapies for intravenous glucocorticoid (ivGC)-refractory acute severe ulcerative colitis (ASUC) are limited. We aimed to evaluate the effectiveness and safety of IFX versus tacrolimus in hospitalized patients with ivGC-refractory ASUC.

METHODS

This retrospective study was conducted between 2017 and 2024 at a tertiary medical center, including inpatients with ASUC who failed ivGC and received IFX or tacrolimus. The primary outcome was colectomy-free clinical response at discharge.

RESULTS

Thirty-seven patients received IFX (median age 27 years; 32.4% males), and 24 received tacrolimus (median age 32 years; 41.7% males). Compared with the patients who received IFX, those receiving tacrolimus had a longer disease duration (4 years vs. 1 year, p = 0.031) and a higher rate of prior exposure to advanced therapy (anti-tumor necrosis factor agent: 58.3% vs. 2.7%, p = 1.05 × 10-6; Janus kinase inhibitors: 20.8% vs. 0%, p = 0.007). The length of hospitalization was significantly longer among those receiving tacrolimus (median 19.5 days vs. 11.0 days, p = 0.019). Colectomy-free clinical response rate at discharge (81.1% vs. 83.3%, multivariate analysis p = 0.956) and total colectomy rate in the following year (12.5% vs. 14.3%, p = 0.851) did not significantly differ between the IFX and tacrolimus groups. Safety profile during hospitalization was comparable between groups.

CONCLUSIONS

In ivGC-refractory ASUC cases, IFX and tacrolimus showed comparable effectiveness and safety. Similar outcomes were observed despite a more treatment-refractory profile in the tacrolimus group. These findings support the use of either agent as a feasible salvage option in this clinical setting.