Adalimumab therapy reduces hospitalization and Colectomy rates in patients with Ulcerative Colitis: Data from controlled trials
Bibliographic record
Abstract
The efficacy and safety of adalimumab (ADA) for the induction and maintenance of clinical remission in patients with moderate to severe ulcerative colitis (UC) was demonstrated in 2 double-blind, placebo-controlled trials (M06-826 and M06-827). We assessed the effect of ADA on the risk reduction of all-cause and UC-related hospitalization and colectomy in these 2 trials. Patients in the 160-/80-mg induction (N=223) and placebo (N=222) arms of M06-826 and patients in the ADA (N=248) and placebo (N=246) arms of M06-827 were combined into a single dataset (N=939). Hospitalization (all-cause and UC-related) and colectomy events were based on serious adverse event reports reviewed by 2 gastroenterologists who were blinded to the treatment groups. The risk of hospitalization was compared between the treatment arms using person-year (PY)-based incidence rates (IRs). Z-scores with confidence intervals were used to determine the statistical difference between treatment groups.1 The number of hospitalizations was compared with Poisson regression with time offset. The table summarizes the hospitalization and colectomy IRs. A 33% reduction in the percentage of patients hospitalized for any reason and a 35% reduction in the number of all-cause hospitalizations were observed with ADA treatment vs. placebo (p<0.05 for both comparisons). When UC-related hospitalizations were compared, the reductions for hospitalization rate (45%) and number of hospitalizations (48%) were both statistically significant. Rates of colectomy were numerically lower in the ADA group compared with the placebo group, representing a 22% reduction. ADA-treated patients had a significantly lower risk for UC-related and all cause hospitalization compared with placebo-treated patients. In addition, a numerically lower colectomy rate in patients receiving ADA therapy vs. placebo was observed. These data support a favorable benefit/risk profile of ADA in UC.
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 | 0.012 | 0.023 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.006 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".