Tacrolimus achieved significantly higher remission rates than infliximab at 8 weeks in refractory ulcerative colitis but was associated with significantly lower long-term colectomy-free survival, according to a study.

Researchers conducted a multi-institutional retrospective study evaluating remission induction and colectomy-free survival in patients treated with tacrolimus or infliximab between 2010 and 2019. Propensity score matching was used to balance 16 baseline characteristics, including Mayo score, C-reactive protein (CRP) levels, and serum albumin.

The study, published in Scientific Reports, included 241 patients (90 tacrolimus, 151 infliximab), all with corticosteroid-refractory or corticosteroid-dependent ulcerative colitis (UC). Propensity score matching resulted in 63 matched pairs. Clinical remission was defined as a partial Mayo score of 2 or less with no sub-score greater than 1. The median observation period was 1,185 days, with colectomies performed in 29 patients (12.0%).

At week 8, clinical remission rates were significantly higher in the tacrolimus group compared to the infliximab group (65.2% vs. 41.3%; P = 0.0016), despite higher baseline disease severity (median partial Mayo score: 7 vs. 5; P < 0.0001). However, the cumulative colectomy-free survival rate was significantly lower for tacrolimus (79.4% at 12 months) than for infliximab (93.7%; P = 0.0286). Long-term colectomy rates were 22.2% for tacrolimus versus 9.5% for infliximab in matched cohorts. Tacrolimus patients generally had higher baseline disease severity, which contextualizes the outcomes.

Adverse events requiring discontinuation occurred in 5.6% (n = 5) of tacrolimus patients and 10.6% (n = 16) of infliximab patients. Infusion reactions were observed exclusively in the infliximab group.

Predictors of colectomy in tacrolimus-treated patients included serum albumin levels ≤3.5 g/dL at week 8, which demonstrated the highest predictive value (AUC: 0.94, P < 0.0001). Tacrolimus maintenance therapy often transitioned to biologics or immunomodulators due to Japanese insurance constraints. These findings underscore the importance of post-remission maintenance strategies, particularly transitioning to biologics when appropriate.

The study concluded that tacrolimus offers superior short-term remission rates but is associated with higher long-term colectomy risks compared to infliximab. Monitoring serum albumin levels post-remission may guide maintenance therapy decisions. The study’s limitations include its retrospective nature and the inability to fully adjust for unmeasured confounders.

Full disclosures and ethics approval details are available in the published study.