Adalimumab safety in global clinical trials of patients with Crohnʼs disease
Bibliographic record
Abstract
BACKGROUND: Adalimumab, a fully human anti-tumor necrosis factor (anti-TNF) monoclonal antibody, is approved for the treatment of Crohn's disease (CD) in adults. We evaluated the overall safety profile of adalimumab in global clinical trials in patients with CD. Patients who participated in these trials, which included randomized induction and maintenance trials, Phase IIIb trials, and open-label extension studies, had moderately to severely active CD and were evaluated for safety at regular intervals. METHODS: Rates of adverse events of interest were assessed per 100-patient-years of adalimumab exposure. Standardized mortality rates and standardized incidence rates (for malignancies) were calculated using population-matched data. As of April 15, 2008, 3160 patients with CD had been treated with adalimumab in clinical trials, representing 3401.9 patient-years of adalimumab exposure. RESULTS: Serious infection was the most frequently reported serious adverse event of interest in the CD trials; abscess (intraabdominal and gastrointestinal related) was the most common serious infection. Low incidences of malignancies, lymphomas, opportunistic infections (including tuberculosis), demyelinating disorders, and lupus-like disorders were reported in the CD trials. The standardized mortality rate for adalimumab-treated patients with CD, 0.44 (95% confidence interval [CI], 0.12-1.12), is less than the rate of 1.52 (95% CI, 1.32-1.74) reported in a recent meta-analysis of patients with CD. CONCLUSIONS: The safety profile of adalimumab in patients with CD was similar to that of other TNF antagonists in CD populations, and the rates of adverse events were comparable to other approved indications for adalimumab spanning >10 years of clinical observation. No new safety signals were identified.
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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 | 0.082 | 0.050 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.003 | 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".