846 Real World Use of Tacrolimus in Combination With Biologicals Is Beneficial in the Treatment of IBD

Abstract

INTRODUCTION: The use of relatively moderate to high doses of tacrolimus in treating refractory inflammatory bowel disease has been reported in multiple studies. However, the efficacy and safety of using low dose (< =2 mg/day, orally) has not been well substantiated, particularly when used in combination with a biologic. The use of relatively moderate to high doses of tacrolimus in treating refractory inflammatory bowel disease has been reported in multiple studies. However, the efficacy and safety of using low dose (< =2 mg/day, orally) has not been well substantiated, particularly when used in combination with a biologic. METHODS: This was a retrospective, observational single center study involving the charts of 124 adults with Crohn’s disease (CD) or Ulcerative Colitis (UC) as diagnosed by endoscopic evaluation, with no history of organ transplant, who had at least two office visits to our clinic. 34/128 patients were eliminated due to insufficient data sets, lack of follow up, or inconsistent usage of the drug. Tacrolimus was administered orally in dosages ranging from 1 mg/day to 9 mg/day. 77/90 (85.6%) patients received concomitant treatment with a biologic (anti-TNF, anti-integrin blocker, or anti-IL-12/23). We utilized a scoring allocation system that relied on patient completion of SIBDQs, fecal calprotectin levels, the physician’s impression of the effectiveness of tacrolimus, and radiographic, pathological, and endoscopic evidence of disease activity. The score ranged from 0-4.0, with 2.0 representing the patient’s baseline state of health prior to starting tacrolimus. Scores above 2 represent improvement in their IBD on therapy. The primary endpoint was the proportion of patients with improvement after starting tacrolimus. Secondary study endpoint was the occurrence of side effects. RESULTS: Overall, 48/82 (58.5%) of patients showed improvement on tacrolimus by standarized score when compared to their baseline. 14/82 (17.1%) of patients maintained their pre-tacrolimus level of health. 20/82 (24.4%) demonstrated a progression in disease activity while taking tacrolimus. 8 patients (8.9%) required surgical resection of bowel between 3 and 20 months following initiation of tacrolimus. Overall 7/82 (8.5%) patients experienced major side effects related to tacrolimus. CONCLUSION: Low to medium doses of tacrolimus (1-4 mg/day) likely enhance the effectiveness of biologic medications, however, well designed, placebo-controlled trials would be required to definitively confirm this finding.