Improvement in Work Productivity and Daily Activities by Certolizumab Pegol in Crohnʼs Disease Patients with Prior Loss of Response or Intolerance to Infliximab
Bibliographic record
Abstract
Purpose: Certolizumab pegol (CZP), a PEGylated Fab' anti-tumor necrosis factor-α (TNF-α), is effective in inducing and maintaining clinical response and remission in active Crohn's disease (CD). Benefits in work productivity and daily activities have been shown in the PRECiSE 1 and 2 trials. In the WELCOME trial, patients with CD with prior loss of response or intolerance to infliximab who responded to induction therapy of CZP 400 mg at Weeks 0, 2, and 4 were randomized to receive CZP 400 mg every 2 or 4 weeks until Week 26. The impact of every 2 weeks (q2w) compared with every 4 weeks (q4w) dosing regimes on work productivity and daily activities was assessed in the WELCOME trial. Methods: Overall work and daily activity levels were evaluated at Weeks 0, 6, 16, and 26 using the validated self-reported Work Productivity and Activity Impairment (WPAI) questionnaire. Mean WPAI scores at Weeks 6, 16, and 26 were compared to those at Week 0 using paired t-tests for each treatment group. The differences in the mean changes of these scores from baseline (BL) to Week 26 between the two groups were evaluated using the Wilcoxon test. Results: Statistically significant improvements (P values ranging from <0.001 to 0.029) were observed in both treatment groups (n=161 in q2w group; n=168 in q4w group) from baseline to Weeks 6, 16, and 26 (Table).The differences in these changes between the two groups were not significant (P values ranging from 0.91 to -0.858).Table: Table. WPAI mean changes from BL at weeks 6, 16 and 26Conclusion: The benefits of CZP on work productivity and daily activities were seen throughout the study period and as early as from the first assessment at Week 6 in patients who have previously failed infliximab treatment. No statistically significant difference was observed in these improvements between CZP 400 mg dosing every 2 or 4 weeks. Disclosure: Dr Feagan is a consultant for UCB; Dr Wolf is a consultant for UCB; Dr Tan is an employee of UCB; Dr Brabant is an employee of UCB; Dr Brown is an employee of UCB. This research was supported by an industry grant from UCB.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| 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 | 0.000 |
| 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".