Effects of Adalimumab Maintenance Therapy on Health-Related Quality of Life of Patients With Crohn's Disease: Patient-Reported Outcomes of the CHARM Trial
Bibliographic record
Abstract
OBJECTIVES: We evaluated the effects of adalimumab maintenance therapy on health-related quality of life (HRQOL) in patients with moderate to severe Crohn's disease. METHODS: In a Phase III, randomized, double-blind clinical trial (CHARM) of moderate to severe Crohn's disease patients, HRQOL outcomes were compared between the adalimumab maintenance treatment groups (every other week and weekly injection) and the adalimumab induction-only group. The Zung Self-Rating Depression Scale, functional assessment of chronic illness therapy (FACIT)-Fatigue, visual analog pain scales, Inflammatory Bowel Disease questionnaire (IBDQ), and Medical Outcomes Study 36-item Short Form Health Survey (SF-36) were analyzed for 499 randomized responders (a decrease of > or =70 points from baseline in the Crohn's Disease Activity Index [CDAI]) at baseline and weeks 4, 12, 26, and 56. RESULTS: CHARM patients' HRQOL was substantially impaired at baseline. Following a 4-week adalimumab induction therapy, patients experienced statistically significant improvements in all HRQOL measures (P < 0.0001). Compared with patients who were assigned to placebo after induction therapy, patients who continued adalimumab at 40 mg every other week maintenance therapy reported less depression (P < 0.01), fewer fatigue symptoms (P < 0.001), greater improvements in the IBDQ (P < 0.05), greater SF-36 physical component summary scores (P < 0.05), and less abdominal pain (P < 0.05) from weeks 12 to 56. They also had greater SF-36 mental component summary scores at week 56 (P < 0.05). Patients who continued adalimumab at 40-mg weekly maintenance therapy reported less depression and fewer fatigue symptoms at week 56, greater improvement in IBDQ, and less abdominal pain from weeks 12 to 56 (all P < 0.05 vs. placebo). CONCLUSIONS: Adalimumab maintenance therapy provided sustained improvements in HRQOL for patients with moderate to severe Crohn's disease through week 56.
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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 | 0.004 | 0.004 |
| 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 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| 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".