Adalimumab Long-term Effectiveness in Adalimumab-Naive Patients With Crohnʼs Disease: Final Data From PYRAMID Registry
Bibliographic record
Abstract
Introduction: PYRAMID was an international multi-center non-interventional postmarketing registry assessing long-term safety and effectiveness of adalimumab (ADA) as used in routine clinical practice. Patients (Pts) with and without prior ADA experience were allowed to enroll. The final long-term effectiveness of ADA is reported in adult ADA-naïve pts (those who had not received ADA before registry enrollment) with moderate to severe Crohn's disease (CD) who were treated according to the local product label. Methods: All pts entering the registry were followed for up to 6 years. Effectiveness of ADA was measured using Physician's Global Assessment (PGA; [a composite of Harvey Bradshaw Index and rectal bleeding score]), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), and 4 components of the Work Productivity and Activity Impairment (WPAI) questionnaire, including absenteeism, presenteeism, overall work impairment, and activity impairment. Effectiveness measures, captured in all pts who received at least 1 dose of ADA in the registry and had at least 1 post-enrollment measurement, were summarized descriptively by the number of observations that were not missing at each registry visit; data were reported as observed. Values at enrollment are considered as baseline values. Results: Among 5025 pts evaluated in the registry, 2057 (40.9%) were ADA-naïve. Of these, 1199 pts (58.3%) were female; mean age 37.1 years at enrollment. Mean±SD ADA exposure for the ADA-naïve subgroup during the registry was 1118.5±842.3 days. A total of 1082 pts (52.6%) had prior exposure to at least 1 anti-TNF/biologic; 853 (41.5%) and 831 pts (40.4%) used immunomodulators and corticosteroids, respectively, at enrollment. Mean change from baseline in effectiveness measures for pts with CD is shown in the table. Mean PGA score and SIBDQ as well as WPAI domains improved in ADA-naïve pts from enrollment to 1 year and were sustained for up to 6 years (table). No new safety signals were identified in the registry. Conclusion: At 1 year after entering the international postmarketing registry of ADA use in routine clinical practice, clinically meaningful improvements in disease activity, work productivity, and activity impairment were achieved in ADA-naïve pts with moderately to severely active CD. These improvements were maintained for up to 6 years of the registry among the pts who remained in the study.Table: Table. Change from enrollment (baseline) in effectiveness measure scores in ADA-naïve pts with CD ( N =2057)
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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 | 0.005 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 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".