Long-Term Safety of Adalimumab in Clinical Trials in Adult Patients With Crohnʼs Disease or Ulcerative Colitis
Bibliographic record
Abstract
Introduction: Adalimumab (ADA) is a fully human anti-tumor necrosis factor (TNF) monoclonal antibody used for the treatment of moderate to severe Crohn's disease (CD) and ulcerative colitis (UC) in patients who have inadequately responded to conventional therapies. Safety from ongoing ADA trials continues to be collected, allowing assessment of long-term safety as the number of patients and the amount of exposure to ADA increase. The aim is to provide an update on the long-term safety profile of ADA in CD and UC patients. Methods: Safety data were evaluated for adult patients with CD or UC treated with ADA in randomized, placebo-controlled, phase 3 and 3b trials as well as their open-label extension studies. Treatmentemergent adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities, version 17.1(2014), and collected from the first dose to up to 70 days after the last dose or through the cutoff date of 31 Dec 2014. AE rates were assessed as events (E) per 100 patient-years (PYs) of exposure to ADA. Results: As of 31 Dec 2014, the ADA clinical safety database contained data for 3689 CD patients and 1789 UC patients, representing 4178.7 and 3371.9 PYs of ADA exposure, respectively. Overall, AE, SAE, and malignancy rates per PYs exposure were similar between the prior and the most recent data cutoffs for each disease state (Table). The type of infections in the Opportunistic infections (excluding TB) category changed in 2014 resulting in an apparent decreased rate (Table). Conclusion: ADA continues to be well tolerated in patients with moderately to severely active CD and UC. No new safety signals were identified with prolonged ADA use in these patient groups.Table 1: Safety Profile of Adalimumab in Adult CD and UC Patients
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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 | 0.046 | 0.057 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| 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".