Abstract
BACKGROUND: Despite the established efficacy of ustekinumab (UST) in Crohn's disease (CD), real-world studies reveal suboptimal treatment persistence and limited endoscopic healing. Current optimization paradigms remain constrained by suboptimal durability and escalating therapeutic demands. OBJECTIVES: To evaluate the clinical utility and safety of intravenous (IV) ustekinumab maintenance therapy in CD. DESIGN: This was a single-center retrospective cohort study. METHODS: This study included CD patients receiving ⩾2 IV-UST maintenance infusions between June 2020 and October 2023 (N = 234). The protocol featured weight-based induction-equivalent dosing (260-520 mg) at response-guided intervals. The primary endpoint was the corticosteroid-free clinical remission rate at Week 24. RESULTS: At 24 weeks, 88.1% (185/210) achieved steroid-free remission with C-reactive protein (CRP) normalization in 90.0% (44/88). Median Harvey-Bradshaw Index decreased from 4 (interquartile range (IQR) 2-5) to 2 (IQR 1-3; p < 0.001). 52-week endoscopic remission (simplified endoscopic score for Crohn's disease ⩽3) reached 48.7% (56/115), with fecal calprotectin normalization in 33.6% (35/104). Multivariate analysis identified baseline CRP >5 mg/L (adjusted odds ratio (aOR) 3.62, 1.16-11.25), intensive dosing (⩾6 cycles/year; aOR 12.06, 1.99-73.05), and disease duration ⩾1 year (aOR 3.53, 1.08-11.54) as predictors of endoscopic non-remission. Safety analysis demonstrated 44.4% adverse event incidence (104/234) and 3.0% serious adverse events (7/234). CONCLUSION: IV-UST maintenance demonstrates high rates of corticosteroid-free clinical remission and endoscopic healing with manageable safety in CD.