Mucosal Healing in Ulcerative Colitis Patients With Week 8 Response to Adalimumab: Subanalysis of ULTRA 2
Bibliographic record
Abstract
To investigate mucosal healing in adult patients with moderately to severely active ulcerative colitis (UC) failing conventional therapy who responded to induction with the anti-tumour necrosis factor (TNF) agent adalimumab (ADA) in the 52-week (wk), double-blind, randomized, placebo-controlled ULTRA 2 trial.1 Patients were stratified by prior anti-TNF use and randomized 1:1 to receive induction dosing with ADA 160/80 mg or placebo (PBO) at wks 0/2, then ADA 40 mg every other week or PBO from wk 4. Concomitant medications were maintained at stable doses, except corticosteroids, which could be tapered beginning at wk 8. Response to ADA induction was assessed at wk 8 in ADA-treated patients by full Mayo score (FMS; response = Mayo score decrease of ≥3 points and ≥30% from baseline and decrease in rectal bleeding score [RBS] of ≥1 or absolute RBS of 0 or 1) and partial Mayo score (PMS, Mayo score without endoscopy subscore; response = PMS decrease ≥2 points and ≥30% from baseline, and RBS criteria as above). At wk 52, the proportion of patients with mucosal healing (defined as a Mayo endoscopy subscore of 0 or 1) was assessed for ADA-treated patients who responded at wk 8 by FMS or PMS, compared with all PBO-treated patients, using non-responder imputation to handle missing data or for patients who moved to open-label dosing at any time (including patients who escalated to weekly dosing) for inadequate response. Subgroup analyses by prior anti-TNF use were also performed. The treatment groups were compared overall (Cochran-Mantel-Haenszel) and by subgroups (chi-square). At wk 8 of ULTRA 2, 50.4% (125/248) of ADA-treated patients responded per FMS, and 49.6% (123/248) responded per PMS. Significantly more patients treated with ADA vs PBO achieved mucosal healing at wk 52, for both FMS and PMS responders (Table). Similar treatment effects at wk52 were observed for anti-TNF-naïve and anti-TNF-exposed patients. In patients with moderately to severely active UC in ULTRA 2, clinically meaningful long-term mucosal healing efficacy with ADA was seen at wk 52 in pts with wk 8 full or partial Mayo score response.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 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 | 0.001 |
| 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".