Tacrolimus or infliximab may help avoid colectomy in UC

Last Updated: 2015-03-30

By Reuters Staff

NEW YORK (Reuters Health) - Tacrolimus and infliximab may help some patients with severe ulcerative colitis (UC) avoid colectomy, new research suggests.

Tacrolimus and infliximab may have similar effects on remission induction in these patients, lead author Dr. Naoki Minami, of Kyoto University in Japan, and colleagues wrote online February 20 in BMJ Open Gastroenterology.

Their data suggest that sequential therapies could be considered for patients with severe UC who failed to respond to initial treatment with tacrolimus or infliximab, they said.

The researchers reviewed their records on all patients who received at least one infliximab infusion or tacrolimus treatment for severe active UC at their hospital over roughly 12 years. Overall, they had data on 29 adults who were followed for a median of 27 months.

All patients had severe disease activity with a Mayo score over 10 and moderate-to-severe inflammation on sigmoidoscopy despite treatment with corticosteroids and/or immunomodulators.

For the induction therapy, clinicians treated 22 patients with tacrolimus and seven with infliximab.

Tacrolimus patients started out on 0.1 mg/kg/day orally or 0.01 mg/kg/day IV, with the dose adjusted to produce whole blood trough levels of 10-15 ng/mL, to induce remission.

Infliximab patients received a single infusion of 5 mg/kg to start, followed if necessary by additional 5-mg/kg infusions at weeks 2 and 6 and then every eight weeks thereafter.

Patients who did not respond to initial treatments, and those who relapsed after responding, were switched to the other drug.

At eight weeks from the start of treatment, the overall clinical remission rate was 65.5% (19 patients) and the colectomy rate was 3.4% (1 patient). The remission rate was 63.6% with tacrolimus (14 of 22 patients) and 71.4% with infliximab (5 of 7 patients).

At 118 months, the overall cumulative colectomy-free survival came to 79.3%, based on Kaplan-Meier survival analysis. Rates were 77.3% at 118 months in the tacrolimus group and 85.7% at 79 months in the infliximab group.

The authors found no serious adverse events with sequential therapies but say efficacy and safety of the approach remain unclear.

Limitations of the study included the small sample size and the differences in the patients' prior care.

The corresponding author did not respond to requests for comment by deadline.

The Japanese Society for the Promotion of Science and the Ministry of Health, Labor, and Welfare supported this research.

SOURCE: http://bmj.co/1bJdD0B

BMJ Open Gastroenterol 2015.