Safety of Adalimumab in patients with Crohnʼs Disease: Analysis of global clinical trials
Bibliographic record
Abstract
Adalimumab, a fully human anti-tumor necrosis factor (anti-TNF) monoclonal antibody, is approved for the treatment of adults with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy or who have lost response to or are intolerant of infliximab. This analysis assessed the overall adalimumab safety across CD randomized pivotal trials, open-label extensions, and Phase IIIb studies in the US (Crohn's Disease WHO Failed Prior Infliximab to Collect Safety Data and Efficacy via Patient-Reported Outcome Measures [CHOICE]) and the European Union (Crohn's Treatment With Adalimumab: Patient Response to a Safety and Efficacy Study [CARE]). All participants in these trials were evaluated for safety at regular intervals. Rates of adverse events of interest to physicians prescribing TNF-antagonist therapy were assessed per 100-patient-years (E/100-PY). The standardized mortality ratio was calculated using the World Health Organization 2002 US mortality data as comparator. As of April 15, 2007, the adalimumab CD clinical trial safety database contained data for 2,228 patients (2,373.7 PYs of adalimumab exposure). Rates of adverse events of interest observed in all CD clinical trials as of April 15, 2007, compared with those from the February 14, 2006, safety update are summarized in the table below. The rate of serious infection was comparable to the rate observed in February 2006 and to rates in published reports of other TNF antagonists.1,2 The rates of adverse events in adalimumab CD and rheumatoid arthritis clinical trials were comparable. In CD trials, the calculated standardized mortality ratio, 0.31 (95% confidence interval, 0.03, 1.11), was less than the published ratio in patients with CD.3 Rates of Adverse Events of Interest The safety profile of adalimumab in the CD clinical trials was similar to that reported previously and to safety reports of other TNF antagonists in CD populations. Adalimumab was generally well-tolerated, and 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 | 0.084 | 0.085 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.006 |
| Bibliometrics | 0.003 | 0.005 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.001 | 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".