Efficacy of combination treatment by ustekinumab and exclusive enteral nutrition in adult patients with moderate-to-severe Crohn’s disease

Despite growing evidence affirming the therapeutic efficacy of ustekinumab (UST) in the treatment of Crohn’s disease (CD), optimizing clinical responses to this biologic continued to pose a significant challenge in clinical practice. From October 2020 to September 2024, a retrospective study was conducted on 114 patients with moderately-to-severely active CD who received optimized ustekinumab by 2 initial intravenous doses in three inflammatory bowel disease (IBD) centers. The patient population was divided into two cohorts: 56 patients received combination therapy of UST and a concurrent 16-week Exclusive Enteral Nutrition (EEN) (UST + EEN cohort), while the remaining 58 patients were treated with UST monotherapy (UST cohort). Clinical and biological outcomes were meticulously evaluated, with endoscopic response and mucosal healing assessed via colonoscopy at both week 16 and week 52. Baseline demographic and clinical characteristics exhibited no statistically significant discrepancies between two cohorts. UST + EEN cohort demonstrated superior outcomes compared to those treated with UST alone, achieving higher rates of clinical response (94.6% vs. 70.7%), clinical remission (89.3% vs. 55.2%), endoscopic response (95.2% vs. 58.8%) and mucosal healing (90.5% vs. 37.3%) at week 16. This therapeutic advantage was maintained to week 52, with 88.2% clinical response, 80.4% clinical remission, 87.5% (colonic lesions) and 87.1% (ileum lesions) endoscopic response, 71.9% (colonic lesions) and 71.0% (ileum lesions) mucosal healing. No severe adverse events were reported. Combination treatment of ustekinumab and a 16-week EEN provided an efficacious and optimized therapeutic strategy, demonstrating robust efficacy for both induction and maintenance treatment in patients with active CD.