Reduced Steroid Usage in Ulcerative Colitis Patients With Week 8 Response to Adalimumab: Subanalysis of ULTRA 2
Bibliographic record
Abstract
To investigate corticosteroid (CS)-free remission and reduction in CS use in adult patients (pts) with moderately to severely active ulcerative colitis (UC) failing conventional therapy who responded to induction with the anti-TNF agent adalimumab (ADA) in the 52-week (wk), double-blind (DB), placebo (PBO)-controlled ULTRA 2 trial.1 Pts were stratified by prior anti-TNF use and randomized 1:1 to receive ADA induction (160/80 mg) or PBO at wks 0/2, then ADA 40 mg every other week or PBO from wk4. Pts using CS at baseline (BL) were included; CS tapering was allowed (not required) from wk8. Response to induction was assessed at wk8 in ADA-treated pts using full Mayo score (FMS; response = Mayo score decrease of ≥3 points and ≥30% from BL and decrease in rectal bleeding score [RBS] ≥1 or absolute RBS ≤1) and partial Mayo score (PMS, Mayo score without endoscopy subscore; response = PMS decrease ≥2 points and ≥30% from BL, and RBS criteria as above). At wk52, the proportion achieving CS-free remission (Mayo score ≤2, no subscore >1) and the proportion free of CS were compared for ADA-treated pts who responded at wk8 (FMS or PMS) vs. PBO-treated pts, overall (Cochran-Mantel-Haenszel) and by prior anti-TNF use (chi-square). Mean percent changes in CS dose from BL to end of DB treatment were compared (ANOVA). Of 150 ADA-treated pts using CS at BL, 90 (60%) responded per FMS, and 90 (60%) responded per PMS at wk8. Compared with all PBO-treated pts using CS at BL (n = 140), significantly more ADA wk8 responders (by FMS or PMS) achieved CS-free remission or were CS-free at wk52 (Table). Similar wk52 results were observed for anti-TNF-naïve and -exposed pts. For ADA-treated wk8 responders, mean percent changes in CS dose from BL to end of DB treatment were −64.4% (FMS) and −68.3% (PMS), vs. −17.5% for PBO-treated pts (P<0.003). In pts with moderately to severely active UC who used CS at BL in ULTRA 2, clinically meaningful long-term CS-free remission and CS-sparing efficacy with ADA was seen at wk52 in pts with wk8 response by full or partial Mayo score. ADA treatment resulted in clinically meaningful reductions in CS doses.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| 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".