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Oral Tacrolimus in Steroid Refractory and Dependent Pediatric Ulcerative Colitis-A Systematic Review and
Rishi Bolia1, Akhil Goel2, Pooja Semwal3
1From the Department of Gastroenterology, Hepatology and Liver Transplant, Queensland Children's Hospital, Brisbane, Australia.
Insights
Oral tacrolimus shows high initial effectiveness in children with ulcerative colitis (UC) who have not used biologics. This treatment offers a 64% colectomy-free survival at one year, serving as a crucial bridge therapy.
Area of Science:
- Pediatric Gastroenterology
- Immunosuppressive Therapy
Background:
- Limited treatment options exist for pediatric patients with steroid-refractory or steroid-dependent ulcerative colitis (UC).
- Observational studies suggest oral tacrolimus may be effective in this population.
Conclusions:
- Oral tacrolimus demonstrates a high initial response rate in biologic-naïve pediatric UC patients.
- It serves as an effective bridge therapy, achieving a 64% one-year colectomy-free survival.
- Further research may explore its long-term efficacy and safety profile.
Background:
There are limited treatment options for children with steroid-refractory or dependent ulcerative colitis (UC). A few observational studies suggest efficacy of oral tacrolimus. We performed a systematic review and meta-analysis to assess the efficacy of tacrolimus in pediatric UC.
Methods:
PubMed and Scopus were searched for publications related to the use of oral tacrolimus in pediatric UC. Data regarding the clinical response and colectomy-free survival were extracted from studies that met the selection criteria.
Results:
The search strategy yielded 492 articles of which 7 studies were included in the final review. They included 166 children (111 steroid-refractory, 52 steroid-dependent, 3 no steroids). Majority of cases (150/166 [90%]) were naïve to biologics. An initial response to tacrolimus therapy was seen in 84% (95% CI: 73%-93%) (n = 7 studies). No difference was observed between children with high (>10 ng/mL) or low tacrolimus levels (127/150 [85%] vs 12/16 [75%], P = 0.3). No difference in initial response between the children who were steroid refractory or dependent (92/111 [83%] vs 46/52 [88%], P = 0.36). The response in the biologic-exposed group (n = 10) was 70%. At 1-year follow-up, 15.2% (95% CI: 7%-21%) (n = 2 studies, 85 patients) had a sustained response on only tacrolimus. The pooled frequency of 1-year colectomy-free survival in children treated with initial oral tacrolimus was 64% (95% CI: 53%-75%). Twelve (7.2%) patients required cessation of therapy because of side effects.
Conclusion:
Tacrolimus has a high initial response in biologic naïve UC children. It can be effectively used as a bridge to other therapies with a 1-year colectomy-free survival of 64%.
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