Abstract
Background/Objectives: Crohn's disease (CD) is a progressive condition, and early treatment with infliximab combined with an immunosuppressant within six months has been shown to improve clinical outcomes. However, the impact of early ustekinumab (UST) use in biologic-naïve CD patients remains unclear. This study aims to address this gap by evaluating the clinical outcomes of early UST intervention in such patients. Methods: In this retrospective cohort study, we included biologic-naïve CD patients treated with UST, with a clinical follow-up period of at least six months from October 2020 to January 2024 across four medical centers. Patients who received UST within six months of CD diagnosis were categorized into the Early-UST group, while those who were initially treated with conventional therapies and subsequently received UST after six months were assigned to the control group. The primary endpoint was the improvement of clinical outcomes at six months. Results: A total of 60 biologic-naïve CD patients were enrolled. Baseline characteristics were comparable between the two groups. At six months, the Early-UST group (n = 24) demonstrated significantly lower Crohn's Disease Activity Index (CDAI) scores (73.03 vs. 112.42, p = 0.038), lower Harvey-Bradshaw Index (HBI) scores (1.46 ± 1.69 vs. 2.72 ± 2.17, p = 0.020), higher rates of clinical remission (91.7% vs. 63.9%, p = 0.017), and higher rates of steroid-free clinical remission (79.2% vs. 50.0%, p = 0.031) compared to the control group (n = 36). At one year, the early-UST group continued to exhibit lower CDAI scores (39.94 vs. 91.48, p = 0.005). Conclusions: Initiating ustekinumab within six months of CD diagnosis is associated with improved clinical outcomes and enhanced quality of life in biologic-naïve Crohn's disease patients.