Efficacy of certolizumab pegol in Crohnʼs disease patients with secondary failure to infliximab is not affected by concommittant medications
Bibliographic record
Abstract
The WELCOME study prospectively evaluated the efficacy of certolizumab pegol (CZP) in patients with moderate to severe Crohn's disease (CD) who had previously responded to infliximab (IFX) but were no longer responding or had developed hypersensitivity. The aim of this analysis was to assess the influence of concomitant corticosteroids (CS) or immunosuppressants (IS) on response and remission rates to CZP in the WELCOME study. Patients (≥ 18 y) with a CD Activity Index (CDAI) score of 220-450 and a history of IFX failure (loss of response and/or hypersensitivity) were eligible for inclusion in WELCOME, a 26-week, multicenter trial consisting of 2 phases: (1) a 6-week open-label induction (CZP 400 mg at Weeks 0, 2, and 4); and (2) a double-blind maintenance phase (CZP 400 mg every 2 or 4 weeks). The primary endpoint was response rate (decrease in CDAI score ≥100 points [CDAI-100]) at Week 6. Secondary endpoints included CDAI-100 response rate and clinical remission (CDAI score of ≤150) at Week 26. Permitted concomitant medications at baseline included: CS at a stable dose for 2 weeks and IS (azathioprine, 6-mercaptopurine, and methotrexate) at a stable dose for 8 weeks prior to screening. CDAI-100 response was achieved by 62% of patients at Week 6. Remission was achieved in 39% of patients at Week 6 and in 30% of patients at Week 26. Baseline use of CS or IS had no impact on response or remission (Table) rates to CZP at Week 6 or Week 26. No caption available. Induction and maintenance therapy with CZP was associated with consistent clinical remission in patients with moderate to severeCDwith secondary loss of response or hypersensitivity to IFX regardless of concomitant treatment with CS or IS.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 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".