Clinically Meaningful Improvement in Health-Related Quality of Life in a Randomized Controlled Trial of Certolizumab Pegol Maintenance Therapy for Crohn's Disease
Bibliographic record
Abstract
OBJECTIVES: Moderate-to-severe Crohn's disease (CD) is associated with important impairment in health-related quality of life (HRQOL). The aim of this study was to assess the effects of certolizumab pegol (CZP) maintenance therapy on HRQOL. METHODS: During an open-label induction phase, study participants with moderate-to-severe CD were treated with 400 mg CZP every other week. Responders were randomized to monthly maintenance therapy with CZP or placebo. Clinically meaningful improvement in HRQOL was evaluated with three patient-reported outcome (PRO) instruments. Quality-adjusted life-years (QALYs) were calculated from utility scores derived from the EuroQoL-5 dimensions (EQ-5D). Normal life rating was measured by combining clinical disease activity, HRQOL, and measures of professional work productivity and daily activity. RESULTS: A total of 425 responders to induction therapy were randomized to CZP maintenance (n=215) or placebo (n=210). Participants assigned to CZP maintenance reported clinically meaningful improvements in HRQOL relative to baseline and to placebo-treated participants. More participants receiving treatment with CZP reported clinically meaningful improvement in Inflammatory Bowel Disease Questionnaire (IBDQ) score (60 vs. 43%, P<0.001) and in Short-Form 36-Item Health Survey (SF-36) physical (51 vs. 34%, P<0.001) and mental component summary responses (44 vs. 32%, P=0.016) than did those receiving placebo. The proportion of participants who achieved clinically meaningful improvement in the EQ-5D plus health status visual analogue scale (VAS) was significantly greater in those assigned to CZP maintenance than in those assigned placebo (57 vs. 38%, P<0.001). There was also a significantly greater gain in QALYs for the CZP group as compared with the placebo group (mean+/-s.d. 0.25+/-0.10 and 0.21+/-0.11; P=0.001). Significantly more participants receiving CZP maintenance reported living a normal life (21.4%) than did those receiving placebo (12.9%, P=0.019). CONCLUSIONS: Maintenance therapy with CZP resulted in statistically significant and clinically meaningful improvements in HRQOL, as assessed by multiple PRO instruments. CZP improved and maintained the quality and quantity of the remission and response, as measured by QALYs. Furthermore, a significant proportion of study participants who received CZP returned to a normal life compared with those who received placebo.
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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) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".