Rapid improvement of patient-reported CDAI diary components by day 8 in active Crohnʼs disease patients treated with certolizumab pegol
Bibliographic record
Abstract
Patients (pts) with active Crohn's disease (CD) require rapid symptom relief. Published data give little resolution and offer only point assessments. The rapidity of a drug's onset of action can be examined through pt-reported diary card component of the CD Activity Index (CDAI). The aim was to investigate onset of action of certolizumab pegol (CZP) by assessing the CDAI components of response, and symptomatic improvement following CZP treatment in PRECiSE 2. Pts with active CD (CDAI 220-450) had open-label (OL) induction with CZP 400 mg (wks 0, 2 and 4). The CDAI was used to determine response (≥100-point CDAI reduction from wk 0). Post-hoc analyses of the 3 pt-reported CDAI components of the diary cards: number of loose/liquid stools/day, abdominal pain and general well-being (table), were examined from baseline to day 8. Findings for wk 6 responders were compared with nonresponders (NRs). Of pts on induction (n= 668), 428 (64%) responded at wk 6 (responders) and received double-blind q4-week maintenance treatment, while 240 (36%) were NRs at wk 6 and discontinued. At baseline (day 0), the mean number of loose/liquid stools was similar in the responders and NRs (4.9 vs 5.1). By day 8, the mean number of stools/day had decreased by 1.5 in the responders (95% CI: -1.7, -1.2) and 0.7 in the nonresponders (95% CI: -1.0, -0.3). At baseline, the majority of responders and NRs rated their abdominal pain as moderate and their general well-being as poor (table). By day 8, there appeared to be a difference in the responders and NRs ratings for abdominal pain (p= 0.002) and general well being (p= 0.001). In the responders and NRs with severe abdominal pain and a terrible general well being at baseline, 17.6% and 11.5% rated no pain, and 16.7% and 9.5% rated themselves as generally well by day 8. Anti-TNF-α therapy, as exemplified by CZP, rapidly improved symptoms as early as day 8, as shown by a reduction in the number of loose/liquid stools, abdominal pain and improvement of general well-being in pts with active CD. No Caption available.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| 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".