DOP47 Characterisation of endoscopic improvement in Crohn’s Disease with upadacitinib treatment
Bibliographic record
Abstract
Abstract Background Upadacitinib (UPA), an oral Janus kinase inhibitor approved for the treatment of moderately to severely active Crohn’s disease (CD), demonstrated significantly higher rates of endoscopic response and remission compared with placebo (PBO) in the phase 3 induction (U-EXCEL, U-EXCEED) and maintenance (U-ENDURE) trials.1 Improvements in the narrowing component of BL stenoses with UPA have been previously reported.2 This analysis evaluated changes in the individual components of the Simple Endoscopic Score for CD (SES-CD) among patients treated with UPA vs PBO. Methods Data were pooled from the two induction phase 3 studies evaluating patients who received PBO or UPA 45 mg (UPA45) once daily (QD) for 12 weeks. Patients who achieved clinical response to 12 weeks of UPA45 were re-randomised in the U-ENDURE maintenance study to receive PBO, UPA 15 mg (UPA15) QD, or UPA 30 mg (UPA30) QD for 52 weeks. This analysis evaluated the mean changes from baseline (BL) in total SES-CD and four individual components (size of ulcers, ulcerated surface, affected surface, presence of narrowing), as well as improvements by disease location and prior biologic failure (bio-failure) status. Results Mean [SD] total SES-CD at BL was similar across treatment groups (induction: PBO 13.9 [7.5], UPA45 14.6 [7.7]). In the overall population, mean [SD] changes from BL in total SES-CD were greater with UPA45 (–6.8 [7.6]) vs PBO (–0.5 [5.7]; P < .0001) at week 12, and at week 52 with UPA15 (–9.9 [8.6]) and UPA30 (–10.3 [8.1]) vs PBO (–2.4 [5.0]; all P < .0001; Figure 1A). Similar results were observed for patients with ileocolonic and colonic disease at week 12 and week 52 (Figure 1A). For patients with prior bio-failure, mean changes from BL in total SES-CD were greater with UPA45 (–6.6 [7.9]) vs PBO (0.0 [5.8]; P < .0001) at week 12, and with UPA15 (–10.4 [9.4]) and UPA30 (–9.7 [7.2]) vs PBO (–2.8 [4.8]; all P < .0001) at week 52; similar findings were reported for patients without prior bio-failure. At week 12 and week 52, treatment with UPA resulted in greater improvements vs PBO in the individual SES-CD components of size of ulcers, ulcerated surface, and affected surface, but not for the presence of narrowing (Figure 1B). Conclusion In patients with moderately to severely active CD, UPA induction and maintenance treatment vs PBO improved total SES-CD, irrespective of prior bio-failure. The changes were driven by the SES-CD components of the size of ulcers, ulcerated surface, and affected surface. When evaluated by disease location, appreciable improvements occurred in patients with ileocolonic and colonic CD, as compared to ileal disease. References: 1. Loftus, E. V. et al. N. Engl. J. Med. 2023;388,1966–80 2. Reinisch, W. et al. UEGW 2023. MP005 [Poster]
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 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 | 0.000 |
| 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".