P712 Real-World Efficacy And Safety Of Ustekinumab And Adalimumab In Patients With Crohn’s Disease: Propensity Matched Analysis
Shin, Y.(1);Hong, S.N.(1)*;Kim, E.R.(1);Chang, D.K.(1);Kim, Y.H.(1);
(1)Samsung Medical Center- Sungkyunkwan University School of Medicine, Department of Medicine, seoul, Korea- Republic Of;
Ustekinumab (UST), an anti-IL-12/23 p40 monoclonal antibody, was shown to be as effective and safe as the anti-TNF-alpha monoclonal antibody adalimumab (ADL) in the treatment of Crohn's disease (CD). Most studies on UST in patients with CD have been conducted in the Western patients and lack in Asian patients with CD. This study aimed to compare real-world clinical efficacy and safety of UST with ADL in Korean CD patients with anti-TNF naïve and failure group.
The retrospective single-center cohort study was conducted on the adult patients with moderated to severe active Crohn’s disease, from 2010 to July 2022. Medical records was extracted from the Clinical Data Werehouse of Samsung Medical Center, Seoul, Korea. Propensity-matched analysis was performed to evaluate patient-reported outcome (PRO)-based clinical remission (PRO3<13) at week 52 and 96 in patient treated with UST and ADL. Subgroup analysis was performed on the biologics-naïve and anti-TNF-failure patients.
A total of 188 CD patients treated with UST and and 299 received with ADL were enrolled. In a propensity -matched cohort adjusted with age, sex, initial CDAI score, and Montreal classification, the clinical remission rate was higher in UST group than ADL at week 52 (Odds ratio [OR] 2.7, 95% confidence interval [CI] 1.31-5.58, P = 0.007) and at week 96 (OR 12.0, 95% CI 1.56-92.29, p = 0.017). In subgroup analysis, there was no significant difference in both group in biologics-naïve group, whereas UST group showed higher clinical remission compared with ADL group in anti-TNF failure group (OR 4.67, 95% CI 1.34-16.23, p = 0.016). Biochemical remission (CRP < 0.05) showed no significant difference between both groups at week 52 and 96. Severe adverse effects leading to biologics discontinuation was numerically high in UST group and ADL group (1, 0.53% vs. 7, 2.34%, p = 0.160).
Compared with ADL, UST showed comparable efficacy in biologic-naïve patients and superior efficacy in anti-TNF failure patients with CD in Korean patients with CD.