P555 Outcomes of multiswitching from original infliximab to biosimilars in patients with inflammatory bowel disease
Bibliographic record
Abstract
Abstract Background Since 2013 multiple Infliximab (IFX) biosimilars became available in the market. While there is evidence that switching from original IFX (RemicadeÒ) to an approved biosimilar product is safe and effective, little is known about outcomes of reverse switching and multiple switching among biosimilars in IBD patients. As the access to biosimilars at competitive prices increases, it is necessary to evaluate multiple switches to provide data on their interchangeability. Our aim was to evaluate the efficacy, safety and pharmacokinetic profile in a cohort of IBD patients who experienced multiple switches. Methods This is a cohort retrospective observational study, enrolling patients with IBD who were successively switched from original IFX to one or more biosimilars (multiswitching). We compared clinical disease activity, assessed using the Harvey-Bradshaw index (HBI) and partial Mayo Score (pMS), biochemical markers (hemoglobin, C-reactive protein (CRP) and albumin), IFX trough levels (ITL) and anti-IFX antibodies (ADA) immediately before and after multiswitching. Adverse and infusion-related events leading to drug discontinuation were registered. Results We included 26 patients (59% male, mean age 35±12 years), 85% (n=22) with Crohn’s Disease (CD) and 15% (n=4) with ulcerative colitis (UC) or indeterminate colitis. The mean disease duration from diagnosis was 9±6 years. According to Montreal classification, most patients were A2 (68%), had ileocolonic disease (L1 51%; L2 9%; L3 50%) and an inflammatory phenotype (B1 41%; B2 23% and B3 36%). Perianal disease was present in 44%. Half of patients had pancolitis (E3). About 51% of the patients had a prior resection surgery and 27% was on combination therapy when the first switch occurred. In 35% (n=9) of the patients three switches were observed. The mean follow-up from the first switch was 15±18 months. There was no significant difference in the proportion of patients in clinical remission (HBI < 5; Mayo score < 3) (91% vs 96%, p=NS). We found no differences in laboratory markers such as CRP (0,79 vs 0,67 mg/dl, p=NS), hemoglobin (13,83 vs 13,75g/dl, p=NS) and albumin (3,98 vs 4,37mg/dl, p=NS) before and after the multiswitching. No significant difference was observed in mean ITL (4,9 vs 4,05 μg/mL, p=NS) or in the proportion of patients with ITL>3ug/ml (p=0.205). None of patients developed ADA, infusion-related events or loss of response leading to drug discontinuation. During our follow-up none of patients was operated. Drug persistence was 100%. Conclusion In our cohort, no significant changes in efficacy, safety or immunogenicity were observed when IBD patients experienced multiple switches between the original IFX and its biosimilars.
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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 | 0.001 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| 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".