How is Crohn’s disease (CD) best managed following intestinal resection to prevent subsequent disease flares and future surgeries?
Post-operative treatment according to risk profile and follow-up endoscopy to confirm mucosal healing lengthens the time to disease recurrence.
De Cruz P, Kamm MA, Hamilton AL, et al. Crohn’s disease management after intestinal resection: a randomised trial. Lancet. 2015;385:1406–17. http://www.ncbi.nlm.nih.gov/pubmed/25542620
Eligible patients had previously confirmed CD with no macroscopic abnormality post-resection. Following curative resection and prior to randomization, patients were stratified into either high or low risk categories for disease recurrence considering smoking status, resection history, and perforating disease.
For 3 months post-resection, all patients received metronidazole (400 mg 2x per day). High risk patients also received either azathioprine (2 mg/kg per day) or 6 mercaptopurine (1.5 mg/kg per day) for 18 months: those intolerant received adalimumab (standard induction with maintenance therapy of 40 mg every 2 weeks). Patients taking prednisolone tapered to 0 within 12 weeks of surgery. Patients with symptomatic recurrence of CD were withdrawn from the trial (modified intention-to-treat analysis, mITT).
Patients were further divided into two study groups: those having an endoscopy at 6 months (“active”) and those not having an endoscopy at 6 months (“standard”). Those undergoing endoscopy at 6 months were eligible for step-up therapy if necessary (low risk patients received thiopurines; high risk patients received increased thiopurine dosing or adalimumab induction and maintenance or increased adalimumab dosing).
There were 122 patients (high risk: 101; low risk: 21) randomized to the “active” group of which 104 had colonoscopy at 6 months. Of the 52 patients in the “without endoscopy group,” 44 were considered high risk and 8 were low risk.
At 18 months, endoscopic recurrence was identified in 49% active care patients vs. 67% standard care (P=0.03). Mucosal normality (Rutgeerts i0) was maintained in 22% active and 8% standard care patients (P=0.03 for mITT). Stepped-up therapy in the active care group led to 18/47 or 38% patients being in remission by month 12. For active care patients in remission at 6 months who did not need stepped-up therapy, 41% were in clinical remission at 12 months. Endoscopic recurrence increased for smokers.
Study Design: Prospective randomized controlled trial
Funding: AbbVie, Gutsy Group, Gandel Philanthropy, Angior Foundation, Crohn’s Colitis Australia, National Health and Medical Research Council (Australia)
Allocation: Computer generated block randomization at each centre (blocks of 3, 2:1) after risk stratification for disease recurrence post-resection
Setting: 17 hospitals in Australia and New Zealand
Level of Evidence: 1b (Oxford Levels of Evidence)
The summary and conclusion in this issue of E-mentoring in IBD pertains to the manuscript(s) being reviewed, and should be considered in the context of what is already known surrounding the topic and incorporated into practice as deemed appropriate by the individual learner.