P712 Real-World Efficacy And Safety Of Ustekinumab And Adalimumab In Patients With Crohn’s Disease: Propensity Matched Analysis
Bibliographic record
Abstract
Abstract Background 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. Methods 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. Results 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). Conclusion 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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".