Impact of Adalimumab (HUMIRA®) on Patient-Reported Outcomes among Patients with Fistulizing Crohnʼs Disease in the CHARM Trial
Bibliographic record
Abstract
Purpose: Fistulas occur in 17–43% of patients with Crohn's disease (CD), and fistulizing disease is associated with worsening quality of life. Complete and sustained fistula closure has been associated with adalimumab (ADA) therapy in the CHARM trial, a Phase III randomized, double-blinded, placebo-controlled assessment of ADA in maintaining clinical remission in patients with CD.[1] Methods: We assessed the impact of ADA maintenance therapy on CD-specific health-related quality of life (HRQOL) among randomized patients with draining fistulas observed at screening visits and at baseline (BL) of the CHARM trial. Inflammatory Bowel Disease Questionnaire (IBDQ) evaluations were conducted at BL and at Weeks 4, 12, 26, and 56 of the CHARM trial. IBDQ scores over time between groups receiving ADA, 40 mg every other week (EOW) or 40 mg every week (EW), or placebo (PBO), were compared using analysis of covariance. The proportions of patients achieving ≥16-point improvement in IBDQ from BL, the minimum clinically meaningful improvement, were compared using chi-square tests. Results: The baseline CDAI and IBDQ were similar for fistulizing patients and non-fistulizing patients (mean CDAI: 314 vs. 311; IBDQ: 123 for both groups). Of 117 patients with fistulizing CD who entered the study, 75 had IBDQ measurements after Week 4 and were followed through Week 56. Statistically significant and clinically meaningful results observed with ADA maintenance were sustained through Week 56. Mean changes in IBDQ scores from BL and the percentage of patients achieving ≥16-point improvement in IBDQ from BL at Week 56 are presented (table).Table: Change From Baseline IBDQ and% of Patients With ≥16-Point Total IBDQ Gain at Week 56Conclusion: Adalimumab maintenance therapy is associated with sustained and clinically meaningful improvement of CD-specific quality of life among patients with fistulizing Crohn's disease as measured by the IBDQ. [1] Colombel JF, et al. Gastroenterology. 2007;132:52–65.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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".