Treatment of small bowel subocclusive Crohn's disease with infliximab: an open pilot study

Stricturing subocclusive small bowel Crohn's disease (CD) is often an indication for surgery. We embarked on an open label pilot study to assess the safety and efficacy of infliximab in patients with stricturing subocclusive CD.

A cohort of patients with a documented and symptomatic small bowel stricture caused by CD was studied. Patients had to be refractory to corticosteroids and/or immunosuppressives, and not in need for immediate surgery. The patients were treated by a single infusion of infliximab 5 mg/kg and followed up at w1, w2, w4 and w8.

After the 6th patients, the study was prematurely discontinued because the predefined safety thresholds of more than 2 surgeries within the first 5 patients was reached. Only two patients completed the 8 weeks study, with a positive response to infliximab and improvement of inflammation confirmed by the CRP and CT scan. Two patients had to be operated early and the last two patients first did well but worsened after one month and were operated 35 and 42 days after infliximab, respectively. No surgical complications occurred in the 4 operated patients. In conclusion, a subset of patients with subocclusive small bowel stricturing CD may benefit from infliximab.