Abstract Background Ustekinumab has demonstrated clinical effectiveness in Crohn’s disease (CD), but its impact on health-related quality of life (HRQoL) in real clinical practice in Korean patients were still limited. This study aims to evaluate the long-term effect of Ustekinumab on HRQoL in Korean patients with moderate-to-severe CD. Methods Adult patients with CD treated with UST were prospectively enrolled in the K-STAR (Post-MarKeting Surveillance for Crohn’s Disease patients treated with STELARA®) study from April 2018 to April 20221. The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) was used to assess HRQoL at baseline, week 16-20 and week 52-66 after ustekinumab treatment. SIBDQ scores were categorized into three levels of impairment: severe (10-45), moderate (45-60) and slight impairment (60-70).2,3 Results Among 464 enrolled patients, 368 completed baseline SIBDQ assessments with 139 completing assessments through week 52-66. Baseline Crohn’s Disease Activity Index scores were significantly higher in patients with severely impaired quality of life (298.7±72.6) versus moderately (269.6±44.2) or slightly (265.0±34.7) impaired quality of life (Table 1). The proportion of patients with severely impaired QoL decreased from 55.7% at baseline to 30.2% at week 52-66 (Figure 1). Biologic-naïve patients showed greater SIBDQ improvements than biologic-experienced patients in terms of change in slightly impaired QoL group (from 9.0% at baseline to 29.6% at week 52-66 in bio-naïve vs. from 7.5% to 10.6% in bio-experienced). Baseline SIBDQ score (p 0.0001), lower BMI (p = 0.0233), and shorter disease duration (p = 0.0110) predicted SIBDQ improvement. Conclusion This study demonstrated ustekinumab showed sustained improvements in HRQoL over one year in Korean patients with CD. Early treatment with ustekinumab in bio-naïve CD patients can be helpful in enhancing quality of life for CD patients. References: 1. Inflamm Bowel Dis. 2025 May 12;31(5):1306-1316. 2. Intest Res. 2021 Jan;19(1):45-52. 3. J Crohns Colitis. 2017 Feb;11(2):165-174. Conflict of interest: Hong, Sung Noh: Grant: National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIP) (2019R1A2C2010404) Future Medicine 20*30 Project of the Samsung Medical Center. Park, Su Bum: No conflict of interest Lee, Dong Hyun: No conflict of interest Lee, Hong Sub: No conflict of interest Moon, Jin Soo: No conflict of interest Ko, Bong Min: No conflict of interest Cho, Young-Seok: No conflict of interest Park, Soo Jung: No conflict of interest Bang, Chang Seok: No conflict of interest Kang, Sang-Bum: No conflict of interest Ryu, Chang Beon: No conflict of interest Cho, Dae Hyeon: No conflict of interest Kim, Hyun Jin: No conflict of interest Kang, Ho Suk: No conflict of interest Kim, Youngdoe: No conflict of interest Ms. Choi, Janet: No conflict of interest Lee, YoungJa: No conflict of interest Im, Jong Pil: No conflict of interest
Hong et al. (Thu,) studied this question.