An in vitro comparison of four different immunoassays for the monitoring of Infliximab biosimilars drug levels
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Bibliographic record
Abstract
BACKGROUND: SB2 (Renflexis®, Merck) and CT-P13 (Inflectra®, Pfizer) are biosimilars of the reference Infliximab (Remicade®, Janssen) and are approved in Canada for use in indications for which Infliximab is approved, including inflammatory bowel disease. These biosimilars are structurally different but exhibit comparable physicochemical characteristics, pharmaceutical effectiveness and immunogenicity compared to Infliximab. Optimal Infliximab therapy currently relies on therapeutic drug monitoring offered by several reference laboratories. OBJECTIVE: Because the appropriate dosing depends on accurate determination of drug levels and anti-drug antibodies, the ability of current Infliximab assays to measure the biosimilars and corresponding antibodies needs to be demonstrated. METHODS: The correlation between Infliximab and the biosimilars measured with four different enzyme-linked immunosorbent assays for Infliximab detection was evaluated. Spiked serum samples were assayed with kits from (A) Immunodiagnostik/ALPCO Diagnostics, (B) R-Biopharm, (C) Theradiag and (D) Progenika Biopharma. The impact of various concentrations of antibodies to Infliximab on the quantification of biosimilars was also tested. RESULTS: A good correlation of SB2, CT-P13 and reference Infliximab spiked serum samples was observed with the four assays. The observed bias between the original drug and biosimilars is clinically insignificant and less than the usual analytical variability observed with these methods. The quantification of the biosimilars and Infliximab was equally impacted in serums containing antibodies to Infliximab. The recovery of the drugs was inversely correlated with the concentration of anti-Infliximab antibodies, suggesting common immunodominant epitopes for SB2, CT-P13 and Infliximab. CONCLUSION: The ability of these assays to properly quantify the biosimilars Renflexis® and Inflectra® has been demonstrated. The therapeutic drug monitoring required for Infliximab therapy can be adequately performed with the biosimilars using the kits currently in use or available in clinical laboratories.
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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 | 0.001 |
| 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 | 0.001 | 0.000 |
| Research integrity | 0.000 | 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 it