Tacrolimus effective in paediatric refractory irritable bowel disease
Tacrolimus is safe and effective in inducing and maintaining remission in paediatric patients with biologic refractory inflammatory bowel disease (IBD), according to a study presented at the 49th Annual Meeting of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition in Athens, Greece.
Tacrolimus has shown efficacy in steroid or biologic refractory IBD in adults, but its long-term efficacy is still unclear. Although it is broadly used in children post-liver transplantation and in autoimmune hepatic disease, there is limited evidence of tacrolimus treatment use in paediatric IBD.
To provide evidence of its efficacy in this cohort, researchers reported their tertiary centre experience of tacrolimus treatment as a concomitant rescue therapy in paediatric refractory IBD patients with and without liver disease.
A total of 10 children (aged 6 to 16 years) were identified from the database between January 2008 and November 2015. Of these, 5 children had pancolitis (3 were male), 2 had Crohn’s disease (1 was male), and 3 had indeterminate colitis (IBDU)(2 were male). Of this cohort, 6 had autoimmune liver disease diagnosed before IBD. Already on low-dose tacrolimus were 5 children, of whom 3 had post-liver transplant colitis.
All patients were resistant to standard IBD treatment before tacrolimus initiation (steroid resistant, refractory to azathioprine, methotrexate, and had lost response to biologic treatment with infliximab and adalimumab). Of these, 2 patients were on tacrolimus and adalimumab together (refractory to infliximab).
Reported data showed that all patients responded well to tacrolimus and clinical remission was documented at 1 and 3 month follow-up. Mean follow up period was 43 months (range from 5 to 70 months).
Tacrolimus was initiated at a dose of 0.1 mg/kg/day and aimed to have levelled between 8 to 10 ug/L within 2 weeks of treatment. Mean pooled tacrolimus trough level on remission was 6.57 g/L (range 3.9 to 12.9 g/L). Patients with concurrent autoimmune liver disease required tacrolimus at lower trough levels to achieve remission compared to patients with only IBD (6.08 g/L vs 12.9 g/L).
Mean faecal calprotectin change on tacrolimus initiation was 905.83 (range 462.5 to 1383.33). Tacrolimus was stopped in one patient with reported persistent vomiting and developed hyponatraemia. None of the participants needed surgery and no mortality was recorded.
While this supports tacrolimus use in paediatric refractory IBD, further long-term data is still needed to confirm the efficacy of tacrolimus, researchers noted.