Tacrolimus confers short-term benefits to patients with inflammatory bowel disease

Tacrolimus appears to be safe and effective in the treatment of Crohn’s disease (CD) and ulcerative colitis (UC), reducing disease activity albeit only in the short term, as shown in a recent study.

Researchers reviewed the medical records of 143 patients (mean age, 38 years; 51 percent male; median disease duration, 110 months) who received oral tacrolimus for luminal or perianal inflammatory bowel disease (IBD). They assessed clinical response using Harvey‐Bradshaw index and partial Mayo score after 3 months. Perianal disease was evaluated by fistula drainage assessment.

At month 3, the median partial Mayo score dropped from 6 at baseline to 3 (p=0.0001) in the group of 58 UC patients, whereas the median Harvey‐Bradshaw index decreased from 9 at baseline to 7 (p=0.011) in the group of 85 CD patients.

In CD, lower clinical disease activity at 3 months was associated with blood tacrolimus concentrations during induction (>10 vs <10 ng/mL; odds ratio [OR], 0.23, 95 percent confidence interval [CI], 0.05‐0.87) and the concomitant use of thiopurines (OR, 0.18, 95 percent CI, 0.04‐0.81).

Among the 62 patients with perianal disease, five with perianal fistulas achieved complete closure (8 percent) while 21 achieved partial closure (34 percent). Treatment was sustained for a median of 6 months.

Over a median clinical follow‐up of 24 months, the rate of treatment‐related adverse events was 34 percent, correlating with blood drug concentrations (p=0.021). A total of 120 patients (84 percent) discontinued tacrolimus, due mostly to absence or loss of response. Three patients (2 percent) were subsequently diagnosed with cancer. The overall rate of surgery was 39 percent, with a 33-percent colectomy rate in UC.

The present data suggest that tacrolimus exerts a transient effect on CD and UC and should be considered only as an induction therapy or a bridging strategy, but not as maintenance treatment, the researchers said.