P493 Comparison of the efficacy of infliximab biosimilar (Remsima®) vs. infliximab original (Remicade®) in patients with inflammatory bowel disease
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. The annual risk of loss infliximab efficacy to be 13–15% per patient/year. The aim of the study is to compare the loss of efficacy of the treatment with Infliximab biosimilar (Remsima®) vs. original Infliximab (Remicade®) in patients with IBD who were “switched” from infliximab original (Remicade®). This was an observational ambispective cohort study of 1 year of follow-up. A cohort (retrospective) constituted by patients with IBD who had a treatment with original Infliximab (Remicade®) in the period of 2014–2015 and another cohort (prospective) constituted by patients whom were switched from infliximab reference (Remicade®) to CT-P13 treatment (Remsima®) in the period of 2015–2016. Baseline characteristics of the patients were analysed, as well as the loss of response in both periods after 12 months of treatment. The activity of the disease was evaluated at 0 and 12 months, according to the Harvey Bradshaw score and partial Mayo score for patients with CD and UC, respectively. The Baseline demographics and phenotypic characteristics of patients with CD and UC, according to the Montreal Classification, are shown in Table 1. Baseline demographics and phenotypic characteristics according to the Montreal classification. Prospective cohort, 98 patients with IBD were included (67 CD/31 CU), 56.1% men, 68.3% non-smokers. 83.6% (56 of 67) of the patients with CD were in remission at the time of the change and 67.7% (42 of 62) at 12 months. In patients with UC, 80.6% (25 of 31) were in remission at the time of the change and 69, 2% (18 of 26) at 12 months. In the retrospective cohort, 98 patients with IBD were included (67 CD/31 CU), 58.2% men, 68.3% non-smokers. 76.1% (51 of 67) of the patients with CD were in initial remission and 68.7% (46 of 67) at 12 months. In patients with UC, 83.9% (26 of 31) were in initial remission and 77.4% (24 of 31) at 12 months. When the loss of efficacy was compared in both periods, no statistically significant differences were observed (p > 0.5). Comparative results of the efficacy Remicade group vs. CT-P13. Both drugs have the same rate of loss of efficacy at 12 months. Therefore, the biosimilar of infliximab is as effective as the long-term reference drug. Comparative and prospective studies are needed to support these results.
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 | 0.002 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".