Clinical characteristics and treatment patterns of ustekinumab in patients with Crohn's disease: Sub-group analysis from a one-year prospective nationwide K-STAR study in Korea

초록

Background: Understanding patient profiles and treatment patterns is critical for optimizing therapeutic strategies, yet real-world data on ustekinumab use in Korean Crohn’s disease (CD) patients remain limited. This study aimed to describe the profile of CD patients treated with ustekinumab and characterize treatment patterns in routine clinical practice in Korea. Methods: The K-STAR study (Post-MarKeting Surveillance for Crohn’s Disease patients treated with STELARA®) was a prospective, observational, multicenter study evaluating effectiveness and safety of ustekinumab in moderate-to-severe CD. Adults receiving ustekinumab from April 2018 to April 2022 were enrolled1 . Patient profiles of super-responders (clinical remission at all visits) versus non-super-responders (no clinical remission at all visits after baseline) were compared. Subgroup analysis assessed ustekinumab monotherapy and combo-therapy with immunomodulators by prior biologic exposure. Baseline characteristics of patients requiring ustekinumab dose escalation from q12w to q8w were also analysed. Results: The super-responders were older at diagnosis (29.4 vs. 25.9 years), had higher BMI (22.2 vs. 20.4), shorter disease duration (88.8 vs. 111.1 months), lower level of disease activity observed by CDAI and CRP, and fewer prior biologic experience than non-super-responders (Table 1). Numerically more super-responders had L1 disease at baseline (33.8% vs. 18.5%) and fewer had L3 disease (58.5% vs. 72.6%) compared to non-super-responders. Bio-naïve patients achieved clinical remission more often than bio-experienced, but no significant difference observed between ustekinumab monotherapy and combo-therapy over one year (Figure 1). Patients requiring dose escalation had lower BMI (20.8 vs 21.9), longer disease duration (116.3 vs 83.3 months), higher perianal disease modifier (39.6% vs 15.9%), elevated fecal calprotectin (2313.3 vs 1278.5 µg/g), more prior biologic exposure (75.4% vs 36.5%) and intestinal resection (38.1% vs 24.4%) at baseline compared to those remained on q12w. Conclusion: Our findings of real-world analysis identified predictors of favorable response to ustekinumab and highlighted the potential need for dose optimization in patients with complex disease features.