P820 Targeting MM-SES-CD < 22.5 for endoscopic improvement is feasible in a clinical trial of Crohn’s disease: A post-hoc analysis of SEAVUE
Bibliographic record
Abstract
Abstract Background It has been demonstrated that a Modified Multiplier of the SES-CD (MM-SES-CD) < 22.5 is the optimal endoscopic threshold that is associated with a low risk of disease progression using data from the CALM long-term extension study. To determine whether or not this threshold would be a pragmatic target within the setting of a clinical trial, we performed a feasibility analysis using data from the phase 3 SEAVUE clinical trial. Methods We considered data from 373 patients from the SEAVUE clinical trial who had available endoscopic data at baseline and were treated with ustekinumab (n=187) or adalimumab (n=186). As participants were only required to have a single ulcer at the time of enrollment in SEAVUE, we further restricted the population to those with MM-SES-CD > 22.5. The primary outcome was MM-SES-CD < 22.5 at week 52. Secondary outcomes were common targets for endoscopic healing in clinical trials, including SES-CD reduction of ≥ 50%, SES-CD < 4, and SES-CD < 3. Clinical remission, defined as CDAI < 150, was also assessed at week 52. Sensitivity analyses were planned to restrict the population to those with moderate to severely active disease activity, defined as MM-SES-CD ≥ 31. Results Of the 373 participants, 55.2% (206/373) participants achieved a MM-SES-CD < 22.5. A total of 206 participants had a MM-SES-CD > 22.5 at baseline, of which 91 (44.2%) attained a MM-SES-CD < 22.5 at week 52. A greater proportion of participants achieved this outcome compared to SES-CD reduction of ≥ 50% (85/206, 41.3%), SES-CD < 4 (52/206, 25.2%), and SES-CD < 3 (36/206, 17.5%) at week 52 (Table 1). A total of 144 participants had moderate to severely active endoscopic disease at baseline (MM-SES-CD ≥ 31), of which 55 (38.2%) achieved a MM-SES-CD < 22.5 at week 52. This was similar to the number of patients who achieved SES-CD reduction of ≥ 50% (61/144, 42.4%), and greater than the number of patients who achieved SES-CD < 4 (34/144, 23.6%) or SES-CD < 3 (21/144, 14.6%) at week 52. Of the 144 participants with a MM-SES-CD ≥ 31 at baseline, a total of 71 received adalimumab and 73 received ustekinumab. Compared to adalimumab, a numerically greater proportion of those treated with ustekinumab achieved MM-SES-CD < 22.5 [33/71 (45.2%) vs. 22/71 (31%), p=0.079] and clinical remission [48/73 (65.8%) vs. 36/71 (50.7%), p=0.067] at week 52. Conclusion Based on this feasibility analysis, a MM-SES-CD < 22.5 is a feasible target to attain in clinical trials of Crohn’s disease. Further, use of the MM-SES-CD for measurement of endoscopic burden could lead to different conclusions being obtained from clinical trials of CD that are clinically and prognostically more relevant.
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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 | 0.024 | 0.025 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.010 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
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".