P-145 WELCOME 54-week Open-label Extension
Bibliographic record
Abstract
Studies have suggested that patients with Crohn’s disease who respond to infliximab (IFX) then lose response may benefit from switching to another TNF antagonist. The WELCOME study (NCT00308581) assessed clinical response and remission at six weeks with certolizumab pegol (CZP) treatment in patients who previously responded to IFX and then lost response. Here, we present clinical response and remission data at 1.5 years in patients from the WELCOME open-label extension study (NCT00333788) according to baseline antibody to infliximab (ATI) status. In the WELCOME study, patients with secondary failure of IFX or adverse events with IFX (N=539) were treated with CZP 400 mg every 2 weeks at weeks 0, 2, and 4. At Week 6, responders (ΔCDAI ≥100) were randomized to CZP 400 mg either every 2 weeks or every 4 weeks for 26 weeks. After 26 weeks, patients who maintained clinical response (ΔCDAI ≥70) were given the opportunity to continue in the WELCOME open-label extension study with CZP 400 mg every 4 weeks up to an additional 54 weeks (total study time, 1.5 years). The primary outcomes include response (ΔCDAI ≥100 points) and remission (CDAI score ≤150). In this analysis, outcomes were studied at Week 54 of the open-label extension study in subsets of patients that were grouped by ATI status. Safety was monitored throughout. Of the 201 participants in the open-label extension study, 94 (47%) were positive for ATIs and 107 (53%) were negative; the mean age was 39 ± 12.1 years (ATI positive) and 38 ± 11.1 (ATI negative). At Week 54, for observed cases, 80%/59% (ATI positive/negative, respectively, p=0.04) of patients maintained response (ΔCDAI ≥100 points), and 63%/56% (p=ns) maintained remission (Table). Adverse events occurred in 87%/93% and serious adverse events occurred in 16%/17% of patients. Clinically important adverse events, including injection site reactions, arthropathies, gastrointestinal events and immune disorders were similar between the two groups (data not shown). No deaths were recorded. Patients who experienced secondary failure of IFX treatment were able to maintain response and remission during 1.5 years of treatment with CZP, irrespective of their ATI status. The incidence of adverse events was similar to previous studies. These data suggest that CZP is a good long-term treatment alternative for patients who had secondary failure of IFX treatment and are ATI positive.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.034 | 0.005 |
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".