Postoperative adalimumab maintenance therapy for Japanese patients with Crohn's disease: a single-center, single-arm phase II trial (CCOG-1107 study)

To investigate the efficacy and safety of planned postoperative adalimumab (ADA) therapy for Japanese patients with Crohn's disease (CD). The subjects of this study were 26 patients who underwent bowel resection for CD. All patients received subcutaneous injections of ADA 160/80 mg at the time of surgery and 2 weeks later, followed by 40 mg every 2 weeks thereafter. The primary endpoint of this study was the incidence of endoscopic recurrence, defined by Rutgeerts endoscopic recurrence scale i2, 1 year after surgery. After the median follow-up period of 41.3 months, the median number of treatments with ADA was 56 and the median time-to-treatment failure was 25.6 months. Endoscopic recurrence was observed in 34.6% of the patients 1 year after surgery. Univariate analyses showed that preoperative ADA therapy was significantly associated with endoscopic recurrence. Clinical recurrence developed in 16.7% of the patients within 1 year after surgery. Secondary surgery for recurrence was not required. Although adverse events (grade 3) were experienced by 15.4% of patients, none was withdrawn from this study. Planned postoperative ADA therapy reduced the incidence of endoscopic and clinical recurrence after bowel resection in Japanese patients with CD. This trial is registered with the University Hospital Medical Information Network (UMIN000007514).