P-138 Sustained Efficacy in Patients with Ulcerative Colitis Treated with Adalimumab
Bibliographic record
Abstract
The efficacy and safety of adalimumab (ADA) for induction and maintenance of remission in patients with moderately to severely active ulcerative colitis (UC) was demonstrated in ULTRA 2.1 Sustained efficacy at weeks 8, 32, and 52 with ADA treatment has not been reported. Adults with UC for >3 months (Mayo score 6–12; endoscopy subscore 2–3) failing corticosteroid or immunosuppressant therapy were randomised to placebo (PBO) or ADA (160/80 mg, week 0/2; 40 mg every other week [eow] from week 4). Anti-TNF-exposed patients were eligible. Patients with inadequate response could move to open-label (OL) ADA (40 mg eow) from week 12. Endoscopy was performed and full Mayo score was calculated at weeks 8, 32, and 52, using the worst rectal bleeding and stool frequency scores from the previous 3 days. Remission (Mayo score ≤2, no subscore >1), response (Mayo score decrease ≥3 points and ≥30% from baseline, and rectal bleeding subscore ≤1 or decreased by ≥1), and mucosal healing (endoscopy subscore ≤1) were assessed at each timepoint. The proportion of patients with efficacy at all 3 timepoints was determined (non-responder imputation: patients who moved to OL ADA or with missing data were considered not to have achieved the endpoint). Results were compared for ADA- versus PBO-treated patients (ITT, Cochran-Mantel-Haenszel test,) and in subgroups by prior anti-TNF use (chi-squared or Fisher’s exact test). ADA-treated patients were significantly more likely than PBO-treated patients to achieve sustained remission, response, and mucosal healing (Table). Anti-TNF-naïve ADA-treated patients were significantly more likely than PBO-treated patients to achieve each of the sustained efficacy endpoints. Anti-TNF-exposed ADA-treated patients had significantly greater rates of response, while remission or mucosal healing rates were numerically but not statistically greater, compared with PBO-treated patients. In ULTRA 2, ADA treatment resulted in statistically significantly greater rates of sustained efficacy at weeks 8, 32, and 52 than PBO treatment, with anti-TNF-naïve patients deriving the largest treatment benefit. Reference: 1. Sandborn WJ, et al. Gastroenterology. 2012:142.
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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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".