4CPS-254 Biosimilar rituximab – a year beyond
Bibliographic record
Abstract
Background The introduction of a biosimilar drug represents similar efficacy at lower cost, providing savings without compromising patient treatment. In oncology, biological therapies account for more than 33% of health expenses.1 Rituximab has a particular profile of first infusion-related reactions (IRR), such as hypersensitivity reactions, hypotension and cardio-respiratory compromise, which may lead to treatment discontinuation.2 Purpose To evaluate the safety profile of biosimilar rituximab in the approved indications and the economic impact of the introduction of biosimilar rituximab. Material and methods Retrospective analysis of first IRR reported to the pharmacy services or described in the patient file with biosimilar rituximab, between July 2017 and July 2018. The switch to biosimilar rituximab was performed in all patients. Results During the analysis period, 127 patients had been treated with biosimilar rituximab. According to their pathology, they were classified into two categories: oncological, 48% and non-oncological disorders, 52%, which included rheumatoid arthritis (RA) and off-label use. In the oncological group, the switch was carried out in 9.8% of patients, 90.2% were naïve. The mean time between the last administration of rituximab and the first administration of biosimilar rituximab was 34 days [(21–58 days). Three suspension cases of biosimilar rituximab have been reported, resulting in two successful re-challenges and one permanent discontinuation. The rate of first IRR was 6.5% in oncological disorders, with three severe reactions (4.9%). Regarding the non-oncological group, the switch was performed in 39.4% of patients, 60.6% were naïve. The mean switch time was 13.6 months (0.9–48 months). One case of suspension was reported, which resulted in a successful re-challenge. The rate of first IRR was 2.9% for RA, with no severe reactions. Biosimilar rituximab introduction translated into a 64% cost reduction of €1 71 000. Conclusion Biosimilar rituximab introduction resulted in significant savings (64%) with no major changes in safety profile (4.5% oncological disorders and none for RA of severe first IRR), when compared with the summary of product characteristics of the originator (12% and 0.5%).2 The difference may be associated with an underestimated report, since it is a commonly used drug with a known IRR profile. References and/or acknowledgements 1. http://www.infarmed.pt/documents/15786/2682984/junho/34525a26–4c19–4035–8132-cfdb29105022?version=1.0 2. Mabthera SPC available at: https://www.ema.europa.eu/documents/product-information/mabthera-epar-product-information_en.pdf No conflict of interest.
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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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.033 | 0.011 |
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".