Tacrolimus (FK506) for induction of remission in corticosteroid-refractory ulcerative colitis

Gordon, Morris orcid iconORCID: 0000-0002-1216-5158, Sinopoulou, Vassiliki orcid iconORCID: 0000-0002-2831-9406, Akobeng, Anthony K, Pana, Mirela, Gasiea, Rehab and Moran, Gordon William (2022) Tacrolimus (FK506) for induction of remission in corticosteroid-refractory ulcerative colitis. Cochrane Database of Systematic Reviews, 2022 (4).

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Official URL: https://doi.org/10.1002/14651858.CD007216.pub2

Abstract

Background
There are a limited number of treatment options for people with corticosteroid‐refractory ulcerative colitis. Animal models of inflammatory bowel disease and uncontrolled studies in humans suggest that tacrolimus may be an effective treatment for ulcerative colitis.

Objectives
To evaluate the efficacy and safety of tacrolimus for induction of remission in people with corticosteroid‐refractory ulcerative colitis.

Search methods
We searched the Cochrane Gut group specialised register, CENTRAL, MEDLINE (PubMed), Embase, Clinicaltrials.gov and WHO ICTRP from inception to October 2021 to identify relevant randomised controlled trials (RCT).

Selection criteria
Two review authors independently selected potentially relevant studies to determine eligibility based on the prespecified criteria.

Data collection and analysis
Two review authors independently extracted data and analysed them using Review Manager Web. The primary outcomes were induction of remission and clinical improvement, as defined by the studies and expressed as a percentage of the participants randomised (intention‐to‐treat analysis).

Main results
This review included five RCTs with 347 participants who had active ulcerative colitis or ulcerative proctitis. The duration of intervention varied between two weeks and eight weeks


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