PYRAMID Registry
Bibliographic record
Abstract
Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody, is approved for the treatment of Crohn's disease (CD) and has been shown to induce and maintain remission in patients with CD. Our objective was to assess the long-term safety of adalimumab as prescribed according to local product labels in PYRAMID (ProductivitY Safety and Efficacy: Long TermR esults inA daliMumab Treated PatIents with Crohn's Disease [Adalimumab Crohn's Safety Registry]), an ongoing observational registry initiated in September 2007 in 24 countries (421 sites), now at year 2. Patients enrolled in PYRAMID during a 2-year enrollment period, with a 6-year study duration for each patient. Study visits are recommended every 3 months through Year 1, then every 6 months. The primary endpoint is safety, including all serious adverse events (SAEs) and adverse events of special interest (AEIs) in an anti-TNF-exposed population. As of 1 December 2009, the fully enrolled study included 5043 patients (mean age, 38 years; 57% female; 96% white). The majority of patients were enrolled outside of North America (34% from US and Canada). Approximately half (49%) had been previously treated with biologics; 35% were treated with concomitant immunosuppressants and 29.5% with concomitant corticosteroids. Most patients (88%) were new adalimumab users at enrollment, with the remainder continuing from prior adalimumab studies. As of 1 December 2009, total adalimumab exposure was 5362.8 patient years. The discontinuation rate was 10.1%; 4.8% discontinued for lack of efficacy. At least 1 treatment-emergent SAE occurred in 11.5% of patients, the most frequent being CD (3.2%), intestinal obstruction (1.3%), and abdominal pain (0.6%); 1.1% of SAEs were uncoded (inquiries pending). There were 7 deaths: 1 motor vehicle accident, 2 suicides, 3 cases of sepsis, and 1 lymphoma. One of the sepsis cases was considered possibly related to the study drug. AEIs are listed in the table.
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 | 0.006 | 0.022 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.004 | 0.005 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.424 | 0.239 |
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".