A Randomized Placebo-Controlled Trial of Infliximab Therapy for Active Ulcerative Colitis
Bibliographic record
Abstract
Purpose: The ACT 1 trial evaluated the safety and efficacy of infliximab (IFX) in UC. Methods: 364 pts with active UC despite corticosteroids/AZA/6-MP, with endoscopic evidence of moderate/severe UC (endoscopy score ≥2) and total Mayo score of 6–12 inclusive, were randomized to placebo (PBO), infliximab (IFX) 5- or 10 mg/kg at wks 0, 2, 6 and q8 wks through wk 46. Primary endpoint was induction of clinical response, defined as decrease in Mayo Clinic score of ≥30% and ≥3 points, with decrease in rectal bleeding score of ≥1 or rectal bleeding score of 0 or 1 at wk 8. Secondary endpoints were clinical remission, defined as Mayo score ≤2 with no individual subscores >1, and mucosal healing defined as endoscopy subscore of 0 or 1. Results: More pts treated with IFX 5- (69.4%) and 10 mg/kg (61.5%) were in clinical response at wk 8 vs PBO (37.2%, p < 0.001 for both). At wk 54, 45.5% and 44.3% of IFX 5- and 10 mg/kg pts, respectively, achieved clinical response vs 19.8% of PBO (p < 0.001, for both). At wk 8, 38.8% and 32.0% of IFX 5- and 10 mg/kg pts, respectively, were in clinical remission vs 14.9% of PBO (p < 0.001 and p = 0.002); this persisted at wk 54 (34.7%, 5 mg/kg; 34.4%, 10 mg/kg vs 16.5%, PBO; p = 0.001 for both). Mucosal healing at wk 8 occurred in 62.0% and 59.0% of IFX 5- and 10 mg/kg pts, respectively vs 33.9% of PBO (p < 0.001, for both); this was maintained at wk 54 (45.5%, 5 mg/kg; 46.7%, 10 mg/kg vs. 18.2%, PBO; p < 0.001 for both). Proportion of pts with ≥1 AE in the IFX group was 89.3%, vs 85.1% in PBO. SAE's occurred in 22.6% vs. 25.6% in the combined IFX and PBO group, respectively. 10.7% of PBO and 11.1% in the combined IFX group experienced ≥1 infusion reaction. In the 5mg/kg IFX group, 1 pt each reported prostatic adenocarcinoma, intestinal dysplasia, and optic neuritis. Serious infections were reported in 4.5% vs 4.1% in the IFX and PBO groups, respectively. One TB case was reported in the 10 mg/kg IFX group. Conclusions: In active UC, IFX reduces signs and symptoms, induces and maintains remission, and attains mucosal healing.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 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".