Abstract Background Comparative data on infliximab (IFX) and tacrolimus (TAC) as salvage therapies for intravenous-glucocorticoids (ivGC)-refractory acute severe ulcerative colitis (ASUC) are limited. This study aimed to evaluate the effectiveness and safety of IFX versus TAC in hospitalized patients with ivGC-refractory ASUC. Methods This retrospective study was conducted at a tertiary medical center, including hospitalized patients with ASUC, who failed ivGC and received IFX or TAC. The primary outcome was colectomy-free clinical response at discharge. Secondary outcomes included one-year colectomy rates, length of hospital stay, and one-year treatment persistence with the same advanced therapy initiated at discharge or at the first follow-up clinic visit. A safety analysis evaluated the incidence of adverse events (AEs) during the index hospitalization. Results A total of 151 patient with ASUC were hospitalized in Sourasky medical center in Tel-Aviv between 2017-2024. Of these, 61 patients were ivGC-refractory and received either IFX n = 37, median age 27 years (interquartile range (IQR): 22-38), 32.4% male or TAC n = 24, median age 32 years (IQR: 26-50), 41.7% male. Patients treated with TAC had a longer disease duration (median 4 years vs. 1, p = 0.03), and higher rates of prior exposure to advanced therapies (anti-tumor-necrosis factor: 58.3% vs. 2.7%, p = 1.05 × 10⁻6; Janus-Kinase inhibitors: 20.8% vs. 0%, p = 0.007). As shown in Table 1, Colectomy-free clinical response rates at discharge, and one-year colectomy rates were comparable between the IFX and TAC groups (89% vs. 87.5%, p = 0.84; 18.2% vs. 17.6%, p = 0.96, respectively). Duration of hospitalization and time to clinical response were shorter among patients treated with IFX length of stay: median 11 days (IQR: 8-17) vs. 19.5 (IQR: 12-22) p = 0.012; time to clinical response: median 2 days (IQR: 1.5-3.5) vs. 4 (IQR: 3-7.5), p = 0.001, respectively. Treatment persistence during the first year was observed in 18 (64.3%) and 7 (41.2%) patients in the IFX and TAC groups respectively (p = 0.135; Figure 1). More patients in the TAC group underwent at least one change in advanced therapy, although this difference did not reach significance in multivariate analysis (58.8% vs. 28.6%, p = 0.29). The incidence of AEs during hospitalization did not differ between groups IFX: n = 26 (70%), TAC: n = 20 (83%), p = 0.134. Conclusion In ivGC-refractory ASUC, IFX and TAC demonstrated comparable effectiveness and safety. Similar outcomes were observed despite a more treatment-refractory profile in the TAC group, including longer disease duration and greater prior exposure to advanced therapies. These findings support the use of either agent as a feasible salvage option in this clinical setting. Conflict of interest: Dr. Sror, Neta: I confirm that I have no conflict of interest, neither financial nor personal, regarding any of the subjects presented at the ECCO 2026 Conference. Tamir-Degabli, Natalie: No conflicts Shaham, Daniel: No conflicts Rozenfeld Hemed, Anna: No conflicts Leibovitzh, Haim: No conflicts Hirsch, Ayal: No conflicts Thurm, Tamar: None Ron, Yulia: No conflicts Fishman, Sigal: No conflicts Maharshak, Nitsan: Grant support from Janssen, Abbott, Abbvie, Pfizer, BMS, Nestle, Helmsley Charitable Trust Personal fees/ advisory board- from Abbvie, Magentiq eye, Lilly, Pfizer, Janssen, BMS, Nestle, Teva, Baemek Advanced Technologies Cohen, Nathaniel Aviv: No conflicts
Sror et al. (Thu,) studied this question.