Efficacy and Safety of Certolizumab Pegol in patients with active Crohnʼs Disease who previously lost response or were intolerant to Infliximab: Open-Label induction results of the WELCOME Study
Bibliographic record
Abstract
The availability of new anti-tumor necrosis factor (TNF-α) agents has made it increasingly common for patients with Crohn's disease (CD) to switch therapies. Current guidelines, however, provide little indication of the expected outcomes of such a strategy. The purpose of this analysis was to assess Week 6 response rates to certolizumab pegol (CZP) in patients with CD who have responded to infliximab (IFX) but who are no longer responding or who have developed intolerability due to acute or delayed infusion reactions. WELCOME is Phase IIIb, multicenter, 26-Week open-label trial Evaluating the clinical benefit of certoLizumab pegol induCtiOn and Maintenance in patients suffering from CD with prior loss of response or intolErance to IFX. Two periods are defined: an open-label induction (CZP 400 mg, Weeks 0, 2, and 4) and a double-blind maintenance phase (CZP 400 mg, Weeks 6-24). Patients with a CD Activity Index (CDAI) score of 220-450 points and a history of IFX failure (any reason) were randomized to CZP 400 mg maintenance either every 2 or every 4 weeks from Week 6. Patients withdrawing (any reason) before Week 6 were considered to be nonresponders. Nonresponders at Week 6 were withdrawn. The primary endpoint was defined as the rate of response (decrease in CDAI score ≥ 100 points) at Week 6. Remission was defined as a CDAI score of ≤ 150 points. In total, 539 patients were enrolled. Median CDAI score at baseline was 293 points (interquartile range: 257.3-349.5). At Week 6, 62.2% (57.9-66.3) (intent-to-treat analysis) of patients achieved response and 39.3% (35.2-43.6) achieved remission. These rates were comparable to those in PRECiSE 2 (64.1% in the overall population and 53.9% in patients previously exposed to IFX),1 suggesting that prior IFX exposure may not reduce response to CZP induction. One-third of patients had responses by Week 2 (33.2%); at Week 4, 43.8% were responders. No new safety concerns were identified. Week-6 data from the WELCOME study indicate that the majority of patients with prior exposure to IFX respond to CZP. CZP is an additional treatment option in patients with CD who have had previous biologic exposure.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| 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 | 0.000 | 0.000 |
| 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".