A Case Series of Treatment of Proctitis With Rectal Tacrolimus in Pediatric Inflammatory Bowel Disease

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Conference Proceeding

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Publication Title

American Journal of Gastroenterology



Inflammatory bowel disease (IBD) is comprised of Ulcerative Colitis (UC) and Crohn’s Disease (CD). Patients with disease limited to the rectum (inflammation that extends no more than 15 cm proximal to the anal verge) are good candidates for receiving topical therapy. Moderately active proctitis/ proctosigmoiditis is initially treated with a topical 5-aminosalicylate (5-ASA) enema or suppository preparation. In patients who have not responded to topical aminosalicylates, topical (rectal) hydrocortisone enema, foam, or suppository can be utilized. For refractory proctitis/ proctosigmoiditis, immunosuppressive therapy (with immunomodulators or biologics) may be required. However, there are times when rectal inflammation may not respond to these conventional therapies. As a result, clinicians at our practice have tried rectal tacrolimus for use in pediatric patients refractory to all other traditional therapies.


Case series of 5 pediatric patients diagnosed with UC or CD with mild-moderate activity as indicated by calculated Pediatric Ulcerative Colitis Activity Index (PUCAI) and Pediatric Crohn’s Disease Activity Index (PCDAI) treated with rectal tacrolimus in either suppository or enema formulation. Dosing varied with patients' BMI at the time of prescribing the medication. Response to the treatment was evaluated with PUCAI or PCDAI scores, paraclinical factors (CRP, Albumin, Fecal Calprotectin), and clinical presentation. Adverse events as a result of the medication were also evaluated.


Three males and 2 females with an average age of 12 were included in this study. Four of the 5 patients were diagnosed with UC with proctitis, while only 1 had CD with proctitis. All 5 patients have been trialed on steroids and unsuccessfully treated, 2 in oral formulation, one with just steroid enema, and 2 with both oral steroid and steroid suppository. All 5 patients previously failed treatment with a 5-ASA enema or suppository (mesalamine or sulfasalazine). Two patients previously failed treatment with immunomodulators or biologic drugs (remicade or entyvio). Of the 5 trialed on the tacrolimus enema, 3 were discontinued for the following reasons: 1 was not consistent with the nightly enemas, 1 was transferred for colostomy at another hospital, and 1 was discontinued due to pain. For the 2 that were able to continue with the treatment, they took the medication daily for over a year and reached Remission/Inactive Disease on PUCAI and PCDAI, respectively. These patients were found to have improved paraclinical indicators with a reduction in CRP and Calprotectin levels. These 2 patients also showed clinical improvement with a decrease in experiencing symptoms of abdominal pain, rectal bleeding, or urgency. Two patients reported adverse effects while on rectal tacrolimus. One experienced a burning sensation in the rectum, while another experienced pain during the administration of the enema.


The results of this case report suggest that rectal tacrolimus may be an effective therapeutic alternative in patients with UC or CD with refractory proctitis and has a generally safe side effect profile.





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2022 Advances in Inflammatory Bowel Diseases Annual Meeting, December 5-7, 2022, Orlando, FL.

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