PYRAMID registry: An observational study of adalimumab in Crohnʼs disease: results at year 3
Bibliographic record
Abstract
Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody, is approved as treatment for Crohn's disease (CD) and has been shown to induce and maintain remission in CD patients. Our objective was to assess the long-term safety of adalimumab as prescribed according to local product labels in PYRAMID, an ongoing observational CD registry in 24 countries, now at Year 3. PYRAMID has a planned 6-year study duration for each enrolled patient. Study visits are scheduled every 3 months through Year 1, then every 6 months thereafter. Safety data is collected including all serious adverse events (SAEs) and adverse events of special interest (AEIs), including serious infections, intestinal obstructions, malignancies, and demyelinating diseases. No Caption available. Of the 5080 enrolled patients, 3866 (76.1%) were ongoing as of December 1, 2010 (mean age, 38 years; 57% female; 96% white) with a cumulative adalimumab exposure of 9249 patient years including exposure from prior adalimumab trials. 24% of patients have discontinued from the registry, most frequently due to lack of efficacy or occurrence of an AE. 51% of patients had been previously treated with biologics, 36% were treated with concomitant immunosuppressants at enrollment, and 30% with concomitant corticosteroids at enrollment. 20% of patients experienced at least 1 treatment-emergent SAE, the most frequent being worsening of CD (5.9%) and small intestinal obstruction (1.4%). AEIs are listed in the table. At the 3-year timepoint, there were no new clinical concerns regarding incidence of SAEs, or AEIs; no new safety signals were observed. These findings are in line with the results from earlier timepoints of PYRAMID.
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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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".