P45 Combining clinical, biological, and health-related quality of life remission with endoscopic improvements: data from SELECTION
Bibliographic record
Abstract
<h3>Introduction</h3> For patients with UC, both subjectively and objectively reported measures are equally important treatment goals. We explored clinical, biological, HRQoL remission and endoscopic improvements as a combined endpoint (CE) from SELECTION (NCT02914522), a phase 2b/3 double-blind trial of filgotinib (FIL), a once-daily, oral, JAK1 preferential inhibitor, for the treatment of UC. <h3>Methods</h3> In SELECTION, patients with moderately to severely active UC were randomized 2:2:1 to FIL 200mg or 100mg (FIL200/100) or placebo (PBO) for an 11-week induction phase followed by a 47-week maintenance period in patients who achieved clinical remission or response. We defined a CE as achieving all of: 1) clinical remission defined as partial Mayo Score (excluding endoscopy domain) ≤2 and no subscore >1, 2) biological remission defined as faecal calprotectin <150 µg/g, 3) IBDQ remission defined as IBDQ >170 and 4) endoscopic improvement defined as Mayo endoscopic subscore ≤1. We evaluated the CE in patients treated with FIL200 vs PBO at week 10 and 58. Among those achieving the CE, we analysed MCID improvement during induction and decline during maintenance on generic QoL instruments (SF-36 and EQ5D). <h3>Results</h3> Overall population included 381 biologic-naïve and 401 biologic-experienced patients undergoing induction, of whom 297 entered maintenance. A higher proportion of patients receiving FIL200 achieved CE than PBO by week 10 in the biologic-naïve cohort (17.6% vs 4.41%, p<0.001) and by week 58 in the maintenance cohort (22.1% vs 7.14%, p=0.002) (<b>table 1</b>). Biologic-naïve CE achievers had higher MCID improvement across all generic QoL scales and domains. Patients achieving CE in maintenance experienced a lower proportion of MCID decline in EQ5D utility, and visual analogue scale. <h3>Conclusion</h3> Treatment with FIL resulted in a higher proportion of patients with combined clinical, biological, HRQoL remission and endoscopic improvements. Among patients achieving this combined composite endpoint, clinically meaningful improvements were observed in their overall QoL. Holistic assessment of several subjective and objective measures may help achieve better outcomes in 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 | 0.007 | 0.005 |
| 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 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.008 | 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".