The following is a summary of “Oral Tacrolimus in Steroid Refractory and Dependent Pediatric Ulcerative Colitis—A Systematic Review and Meta-Analysis,” published in the August 2023 issue of the Pediatric Gastroenterology and Nutrition by Bolia et al.

A restricted number of therapeutic alternatives are available for pediatric patients diagnosed with steroid-refractory or steroid-dependent ulcerative colitis (UC). Several observational studies indicate the effectiveness of oral tacrolimus. A systematic review and meta-analysis were conducted to evaluate the efficacy of tacrolimus in treating pediatric ulcerative colitis (UC). PubMed and Scopus databases were queried for scientific literature about using oral tacrolimus in treating pediatric ulcerative colitis. Information about the clinical response and survival without colectomy was extracted from studies that fulfilled the specified selection criteria.

The search strategy resulted in the identification of 492 articles, of which 7 studies were deemed eligible for inclusion in the final review. About 166 pediatric patients were enrolled in the study, comprising 111 cases of steroid-refractory disease, 52 points of steroid-dependent illness, and 3 cases without steroids. Most patients (150/166 [90%]) had no prior exposure to biological medications. An initial positive reaction to tacrolimus therapy was observed in 84% of cases (95% CI: 73%–93%) based on data from 7 studies. No significant disparity was noted among pediatric patients with elevated (>10 ng/mL) or diminished tacrolimus concentrations (127/150 [85%] vs 12/16 [75%], P = 0.3). There was no significant variation in the initial response observed among the pediatric patients who were refractory to steroids or dependent on them (92 out of 111 [83%] vs 46 out of 52 [88%], P = 0.36). The observed outcome in the group exposed to the biological agent (n = 10) was 70%. 

At the 1-year post-treatment assessment, 15.2% (95% CI: 7%–21%) of the study population, consisting of 85 patients across 2 studies, exhibited a sustained response solely to the administration of tacrolimus. The combined occurrence rate of 1-year colectomy-free survival in pediatric patients who received initial oral tacrolimus was 64% (95% CI: 53%–75%). Around 12 (7.2%) patients necessitated treatment discontinuation due to adverse effects. Tacrolimus exhibits a notable initial therapeutic effect in pediatric patients with ulcerative colitis who have not previously received biological treatments. It can be efficiently utilized as a medical intervention to complement other therapeutic approaches, resulting in a 1-year survival rate without colectomy of 64%.

Source: journals.lww.com/jpgn/Abstract/2023/08000/Oral_Tacrolimus_in_Steroid_Refractory_and.18.aspx