Efficacy of thiopurines and adalimumab in preventing Crohn's disease recurrence in high-risk patients - a POCER study analysis

BackgroundCrohn's disease recurs in the majority of patients after intestinal resection. AimTo compare the relative efficacy of thiopurines and anti-TNF therapy in patients at high risk of disease recurrence. MethodsAs part of a larger study comparing post-operative management strategies, patients at high risk of recurrence (smoker, perforating disease, 2nd operation) were treated after resection of all macroscopic disease with 3months metronidazole together with either azathioprine 2mg/kg/day or mercaptopurine 1.5mg/kg/day. Thiopurine-intolerant patients received adalimumab induction then 40mg fortnightly. Patients underwent colonoscopy at 6months with endoscopic recurrence assessed blind to treatment. ResultsA total of 101 patients [50% male; median (IQR) age 36 (25-46) years] were included. There were no differences in disease history between thiopurine- and adalimumab-treated patients. Fifteen patients withdrew prior to 6months, five due to symptom recurrence (of whom four were colonoscoped). Endoscopic recurrence (Rutgeerts score i2-i4) occurred in 33 of 73 (45%) thiopurine vs. 6 of 28 (21%) adalimumab-treated patients [intention-to-treat (ITT); P=0.028] or 24 of 62 (39%) vs. 3 of 24 (13%) respectively [per-protocol analysis (PPA); P=0.020]. Complete mucosal endoscopic normality (Rutgeerts i0) occurred in 17/73 (23%) vs. 15/28 (54%) (ITT; P=0.003) and in 27% vs. 63% (PPA; P=0.002). The most advanced disease (Rutgeerts i3 and i4) occurred in 8% vs. 4% (thiopurine vs. adalimumab). ConclusionsIn Crohn's disease patients at high risk of post-operative recurrence adalimumab is superior to thiopurines in preventing early disease recurrence.