Comparison of the effectiveness of infliximab and adalimumab in preventing postoperative recurrence in patients with Crohn's disease: an open-label, pilot study.

ABSTRACT

BACKGROUND: Endoscopic and clinical recurrence of Crohn's disease (CD) appears in up to 80 and 30 % of patients, respectively, 1 year after surgery. Both infliximab (IFX) and adalimumab (ADA) have been demonstrated to be effective in reducing the possibility of recurrence after surgery, but head-to-head studies have not been performed so far. The aim of this open-label prospective study was to compare endoscopic, histological and clinical recurrence after 1 year of treatment with IFX or ADA as postoperative prophylaxis in CD patients with a high risk of recurrence. METHODS: Consecutive CD patients who underwent curative ileocolonic resection were randomized to receive IFX or ADA for 1 year. Co-primary endpoints were endoscopic, histological and clinical recurrence after 12 months of therapy. RESULTS: Twenty consecutive CD patients (9 males and 11 females; median age 32.5 years, range 20-39 years) were enrolled after undergoing curative ileocolonic resection. Among the 10 patients treated with IFX, 2 (20 %) had endoscopic recurrence compared to 1 (10 %) in the group of 10 ADA patients (p = 1.0). Three out of 10 (30 %) IFX patients and 2 out of 10 (20 %) ADA patients had histological recurrence (p = 1.0). No significant clinical differences were found between the two groups. CONCLUSIONS: IFX and ADA were similar in preventing histological, endoscopic and clinical recurrence after curative ileocolonic resection in high risk CD patients.