The benefits and risks of concomitant immunomodulators with infliximab maintenance therapy in patients with luminal Crohn's disease (CD) have not been adequately evaluated. We studied the influence of immunomodulator discontinuation in patients in remission with infliximab therapy through a restrospective case-control study.

Medical records of 37 patients with luminal CD who received infliximab at four medical centers were retrospectively analyzed. We compared clinical and follow-up data of patients who were treated with infliximab alone with that of patients with combination therapy.

Among 37 patients, 31 (83.7%) were treated with infliximab plus azathioprine and six (16.2%) were treated with infliximab alone. Of the 31 patients receiving combination maintenance therapy, 26 (83.9%) were in complete remission after 12 months, as compared with five of six patients (83.3%) receiving infliximab alone. No significant difference was observed in remission rate between two groups ( P =0.735). In total, 16.1% of patients in combination therapy and 16.7% in infliximab alone group reported side effects ( P =1.000), but serious adverse events such as reactivation of tuberculosis were noted in only one patient in combination therapy group.

Concomitant immunomodulators did not improve efficacy in patients with luminal CD who received scheduled infliximab maintenance.