P519 Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: Multicentre study at 12 months results
Bibliographic record
Abstract
Infliximab have changed the natural history of inflammatory bowel diseases (IBD). However, with the advent of biosimilar treatment such as CT-P13 promises to improve availability of biological therapy. Nowadays switching data are currently limited. Here, we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product (RP) in patients with IBD. This was a multicentre prospective observational study conducted at the Virgen Macarena Hospital and Juan Ramon Jiménez Hospital (Seville- Huelva, Spain) from March 2015 to February 2016 in patients with Crohn’s disease (CD) and ulcerative colitis (UC). All patients were switched from infliximab RP (Remicade®) to CT-P13 treatment and followed for up to 12 months. The efficacy endpoint was the change in clinical response assessed at 0 and 12 months, according to the Harvey-Bradshaw score and partial Mayo score, and C-reactive protein (CRP) for patients with CD and UC, respectively. A total of 167 patients with IBD (116 with CD and 51 with UC) were included. The Baseline demographics according to the Montreal Classification are shown in Figure. Basal remission 87.4% (146 of 167), 12 months post switch 71.7% (109 of 152). Loss of efficacy at 12 months was 15.7%. 9% of patients discontinued CT-P13 during follow-up. CD patient group 88.8% (103 of 116) of patients with CD were in remission at the time of the switch and 69.7% were in remission at 12 months (P > 0.05. In total, 94.0% (109 of 116) of patients with CD completed 12 months of follow-up. The HB score showed significant changes over the 12-month period (median HB score: 1 [0–1] vs. 1 [0–2] (p = 0.001. No significant changes in median CRP levels were observed at 12 months (p = 0.49). UC patient group 84.3% (43 of 51) of patients with UC were in remission at the time of the switch and 76.7% were in remission at 12 months (p > 0.05). In total, 84.3% (43 of 51) of patients with UC completed 12 months of follow-up. No significant changes in the median partial Mayo score (p = 0.87) were observed at 12 months. Significant changes in the median CRP level were observed over the same period (0.8 [0–4] vs. 0.23 [0–0.58]) (p = 0.003). Serious adverse events related to medication were reported in 12 of 167 (7.2%). Abstract P519 – Baseline characteristics study patients. Switching from infliximab RP to CT-P13 is safe and efficacious at 12 months. Loss of efficacy at 12 months was 15.7%. Global remission in patients with IBD.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| 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) | 0.000 | 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 teacher head, 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".