P1005 Comparative short-term effectiveness of tofacitinib and upadacitinib in refractory, moderate-to-severe ulcerative colitis – An international, multicenter cohort study
Bibliographic record
Abstract
Abstract Background Limited comparative data is available on the real-world effectiveness and safety of tofacitinib (TOFA) and upadacitinib (UPA) in ulcerative colitis (UC). Methods We conducted an international, multicenter, real-life retrospective cohort study to assess and compare the short-term effectiveness of TOFA and UPA in bio-experienced, moderate-to-severe UC. The primary outcome was week 12 corticosteroid-free remission (CSFR) defined as clinical remission (CR; partial Mayo score [pMayo]<2 with a rectal bleeding subscore of 0) and C-reactive protein (CRP) ≤5 mg/L, as well as not receiving local and systemic steroids ≥30 days. The secondary outcomes were CR and biochemical remission (defined as CRP ≤5 mg/L and fecal calprotectin [Fcal] ≤ 250 mg/g) assessed at week 8 and week 12. Data was handled by intention to treat analysis. We performed multivariable logistic regression models with backward stepwise elimination to control potential confounders and to reduce bias. The most reliable models were selected based on ROC analyzes with highest area under the curve (AUC). Statistical power was calculated on the primary outcome with the number of subjects involved, resulting in 1-β=0.97. Results With the participation of 13 tertiary IBD centres, a total of 350 UC patients (Table 1.; mean age: 38.6 ± 13.8 years; 58.6% male) were enrolled in the study. Patients receiving UPA were more likely (OR=4.01 [95%CI: 1.49-10.82]) to achieve CSFR by week 12 compared to the patients on TOFA (47.1% vs. 22.4%). Additionally, higher baseline pMayo (OR=0.76 [95%CI: 0.59-0.98]) and baseline concomitant steroid use (OR=0.17 [95%CI: 0.08-0.40]) decreased the probability of reaching the primary outcome (AUC=0.80). Furthermore, UPA-treated UC patients were more likely to achieve CR at week 8 (54.8% vs. 26.4%; OR=4.06 [95%CI: 1.66-9.93; AUC=0.76]), and at week 12 (69.2% vs. 45.1%; OR=2.3 [95%CI: 1.04-5.13]; AUC=0.80), as well as biochemical remission at week 12 (43.3% vs. 27.3%; OR=6.96 [95%CI: 2.59-18.7]) than patients receiving TOFA. IBD-related hospitalisation was needed in 6.1% (15/246) of the patients on TOFA, as compared to 1.9% (2/104) of patients receiving UPA. Near-significant difference was observed in colectomy rates between the two patient groups (UPA vs. TOFA: 0% vs. 3.7%; p=0.066). Herpes zoster infection was reported in 1.6% (4/246) of the TOFA-treated patients, and in 1.0% (1/104) of the UPA-treated patients. No venous thromboembolism was observed. Conclusion Based on our real-life data, UPA might be associated with better short-term clinical outcomes compared with TOFA in refractory, moderate-to-severe UC.
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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 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".