Abstract 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. Reference: 1. Inflamm Bowel Dis. 2025 May 12;31(5):1306-1316. Conflict of interest: Prof. Dr. Jang, Byung Ik: No conflict of interest Kim, Tae Oh: No conflict of interest Song, Ki Hwan: No conflict of interest Lee, Ok-Jae: No conflict of interest Kim, Dongwoo: No conflict of interest Lee, Hyun Seok: No conflict of interest Chung, Yun Jin: No conflict of interest Park, Dong II: No conflict of interest Bang, Ki Bae: No conflict of interest Moon, Hee Seok: No conflict of interest Kim, Seong-Eun: No conflict of interest Park, Jihye: No conflict of interest Kang, Ben: No conflict of interest Jang, Hyun Joo: No conflict of interest Jeon, Seong Ran: No conflict of interest Kim, Youngdoe: No conflict of interest Choi, Jong Min: No conflict of interest Lee, YoungJa: No conflict of interest
Jang et al. (Thu,) studied this question.