P0945 Improvement in Endoscopic Score in Patients with Moderately to Severely Active UC Treated with Risankizumab in the Phase 3 INSPIRE and COMMAND Studies
Bibliographic record
Abstract
Abstract Background The STRIDE-II recommendations highlighted the importance of targeting objective measures of disease control, including endoscopic healing, in patients (pts) with ulcerative colitis (UC).1 Risankizumab (RZB), an interleukin-23 specific inhibitor, showed improvement in the outcomes of clinical remission and endoscopic improvement compared to placebo in pts with moderately-to-severely active UC.2 Visualizing the changes of endoscopic scores from induction and maintenance may provide insight into pt disease course during treatment. Thus, this analysis sought to provide an overview of change in endoscopic scores of pts enrolled in UC clinical studies. Methods Using individual pt data from the Phase 2b/3 studies of RZB in UC, changes in Mayo endoscopic scores in induction and maintenance were assessed. For induction, pts received either intravenous (IV) placebo (PBO) or RZB for 12 weeks (wks). Pts from the Phase 2b and Phase 3 INSPIRE studies who had a clinical response to induction treatment were rerandomized into the maintenance study [COMMAND] and received subcutaneous PBO (withdrawal), RZB 180 mg, or RZB 360 mg every 8 wks for 52 wks. To be eligible for INSPIRE, pts had to have a baseline (BL) Mayo endoscopic score of 3 or 2 confirmed by central review. For this analysis, endoscopic scores are reported for induction BL and wk 12 and maintenance BL and wk 52 for each treatment. "Endoscopic improvement" was defined as a score of 1 or 0 at the time of follow-up. Results Among pts with a Mayo endoscopic score of 3 at induction BL, 28% achieved endoscopic improvement after 12-wk treatment with RZB 1200 mg; 57% of pts with a BL score of 2 showed endoscopic improvement (Fig. 1). In contrast, among PBO-treated pts with a score of 3 or 2 at BL, 11% and 18%, respectively, achieved endoscopic improvement after induction. Most PBO-treated pts (63%) had no score change at wk 12. During the maintenance study, 29%–35% of pts in the RZB treatment groups had an endoscopic score of 2 or 3 at maintenance BL. (Fig. 2). For those with a BL score of 3, most pts receiving RZB 360 mg achieved endoscopic improvement (62%); similarly, 65% of those with a BL score of 2 showed endoscopic improvement at wk 52. Trends were similar for RZB 180 mg with ≥80% of pts with a BL score of 1 or 0 maintained a 1 or 0 through wk 52. Among PBO-treated pts, ≥60% maintained a score of 3 or 2 from maintenance BL to wk 52; approximately one third of pts’ scores improved to 1 or 0. Conclusion This analysis showed that RZB treatment improved endoscopic outcomes from wk 0 to wk 12 of induction and wk 0 to wk 52 of maintenance. These findings may help inform treatment expectations and shared decision-making for pts with UC initiating RZB treatment. References 1.Turner D, et al. Gastroenterology. 2021;160(5):1570-1583. 2.Louis E, et al. JAMA. 2024;332(11):881-897.
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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 | 0.009 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.000 | 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 | 0.001 |
| 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".