Efficacy And Safety Of Tacrolimus In The Treatment Of Steroid-dependent Or Steroid-resistant Inflammatory Bowel Disease

Background: Tacrolimus is a calcineurin inhibitor.Previous studies and expert consensus have proven that it is effective and safe for induction of remission in steroid refractory inflammatory bowel disease(IBD).This single-center,retrospective study is intended to explore the efficacy and safety of oral tacrolimus in remission induction and maintenance therapy for steroid refractory IBD patients.Methods: A total of forty one adult patients with steroid refractory inflammatory bowel disease were enrolled,including Crohn’s disease(CD,n=20)and ulcerative colitis(UC,n=21).The starting dose of tacrolimus was 0.1 mg/kg/day,aiming at serum concentration of 10–15 ng/m L for remission induction and 5-10 ng/m L for maintenance of remission.Results: After 3 months of oral tacrolimus treatment,41.5%(17/41)of patients achieved clinical remission,of which the clinical remission rate for CD patients was 55.0%(11/20),and 28.6%(6/21)for UC patients.There was no significant difference between CD and UC patients(P=0.162).After 12 months of tacrolimus treatment,62.9%(17/27)of IBD patients was sustained clinical remission,of which 73.3%(11/15)were in CD patients and 50.0%(6/12)in UC patients respectively.There was no significant difference between CD and UC patients(P=0.257).In addition,some UC patients underwent colonoscopy assessments at 3 and 12 months.Because the common lesions in CD patients are mostly localized in the small intestine and the availability of endoscopic assessment is difficult,some CD patients have undergone radiographic evaluation(CTE or MRE).The ratios of inactive phases of imaging were 33.3%(1/3)and 50.0%(6/12)at 3 months and 12 months respectively.Adverse effects of tacrolimus include: elevated serum amylase(24.4%),gastrointestinal symptoms(17.1%),tremor(14.6%),nephrotoxicity(9.8%),and elevated fasting blood glucose(9.8%),Leukopenia(7.3%),liver damage(2.4%),and elevated serum creatine kinase levels(2.4%).Most adverse effects were managed conservatively but one patient(2.4%,1/41)switching to infliximab because of severe alopecia.Conclusion: Tacrolimus is effective and safe in the treatment of patients with steroid refractory IBD,and it can be used for remission induction and maintenance therapy.