P694 Non-medical mandatory reversed and back and forth switch between infliximab and its biosimilar: Early clinical outcomes
Bibliographic record
Abstract
The use of biosimilar infliximab (IFX) is effective and safe in inflammatory bowel disease (IBD). Switching from the originator to a biosimilar in patients with IBD has been successful in multiple IBD cohorts, although scientific and clinical evidence is absent on reverse and/or multiple switching. The aim of the present study was to evaluate short-term drug sustainability, safety and immunogenicity profile of reversed switching from biosimilar to originator IFX in a consecutive multicentre real-life IBD cohort. Consecutive stable patients on maintenance biosimilar IFX were included in from four IBD centres. Clinical, laboratory parameters, therapeutic drug monitoring (TDM) and safety profile is collected at switch and after 24 weeks after the switch. Since 2014, the use of biosimilar IFX was mandatory for IFX-naïve patients or IFX-exposed patients with at least a 1-year drug holiday in Hungary. In August 2017, due to the policy change of the National Health Insurance Found (OEP) a non-medical reversed switch was mandatory in all patients from the biosimilar to the originator IFX. One hundred and seventeen IBD patients (98 cD/19UC, 49.6% males, median age: 36 (IQR: 28–43.5) years, age at onset: 25 (IQR: 19.5–34) years) were included. CD patients had in 28/58.1% colonic/ileocolonic, in 43% complicated disease with 54.8% of patients with perianal disease. Majority of UC patients had left-sided colitis or extensive colitis (41.7/50%). The frequency of previous originator therapy was 14.1% in CD and 8.3 % in. Concomitant immunomodulators and steroids were used in 53.8/45.8% and 7.5/37.5% of CD/UC patients at switch. Before the switch, median CDAI, PDAI and partial Mayo score was 54 (IQR: 40–97), 1 (IQR: 1–4), and 1 (IQR: 0–3). Median baseline CRP was 5 (IQR: 3–10) /3 (IQR: 2–5) in CD/UC. All but one patients tolerated the first infusion after the switch (one infusion reaction). Follow-up and TDM measurements are in progress. According to our knowledge, this is the first real-life cohort on mandatory reverse switch from biosimilar to originator IFX in IBD patients. Short-term drug sustainability was high, follow-up and TDM results are in progress.
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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 | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| 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".