P0924 Efficacy and Safety Assessment of Ustekinumab in Postoperative Crohn’s Disease Patients in China

Abstract Background Crohn’s disease (CD) poses a significant risk of postoperative recurrence (POR), complicating management, and data on the use of Ustekinumab (UST) in postoperative CD patients in China is limited. This study evaluated the efficacy and safety of UST in preventing POR. Methods This multicenter, retrospective observational study involved postoperative CD patients from four Chinese tertiary hospitals, all of whom had at least two high-risk recurrence factors. Patients who failed anti-TNF-α treatments or Vedolizumab switched to UST as non-first-line therapy, while others received UST as first-line treatment at least two weeks post-surgery. Efficacy was evaluated using endoscopic success (Rutgeerts score) and clinical disease activity (Harvey-Bradshaw Index [HBI]), with safety determined by adverse events after a minimum follow-up of 24 weeks. Results This study included 53 patients with a mean age of 36.8 years. Significant improvement in the Rutgeerts score was observed (p < 0.001). The remission rate (i0) increased from 0.0% to 32.1% post-treatment. Notable changes were seen in i1 (from 5.7% to 32.1%) and i2 (from 49.1% to 28.3%), while severe disease cases (i3 and i4) declined significantly. Overall, the endoscopic success rate was 83.0%. Similarly, the HBI score significantly improved (mean ± SD: 6.1 ± 2.5 before vs. 2.4 ± 1.7 after, p < 0.001). The median HBI decreased from 6.0 to 2.0, with remission rates rising from 18.9% to 90.6%, while active disease cases fell from 81.1% to 9.4% (p < 0.001). The percent of 90.3 in the first-line group experienced a decrease in their Rutgeerts score, compared to 72.7% in the second-line group, though this difference was also not statistically significant (p = 0.093). A significant difference was noted in HBI scores (p = 0.016), with the first-line group’s mean at 1.9 ± 1.3 being significantly lower than the second-line group’s 3.1 ± 1.9. The median HBI followed this trend, with values of 2.0 for the first-line and 3.0 for the second-line group. The mean BMI increased from 19.9 ± 3.8 to 21.1 ± 3.7, though not significantly (p = 0.078). Nutritional status improved, as indicated by increased mean albumin (41.3 ± 15.2 vs. 43.7 ± 15.3, P = 0.043) and hemoglobin levels (116.6 ± 24.9 vs. 125.9 ± 23.9, P = 0.019). Only one adverse event, secondary kidney function impairment, was reported. Conclusion UST exhibited significant efficacy in preventing POR of CD with a favorable safety profile, whether used as a first-line or non-first-line treatment. Our research provided essential evidence from an Eastern population regarding the effectiveness and safety of UST in postoperative CD patients. References Torres J, Bonovas S, Doherty G, et al. ECCO Guidelines on Therapeutics in Crohn’s Disease: Medical Treatment. J Crohns Colitis. 2020. 14(1): 4-22.