Efficacy and Tolerability of a Biosimilar Infliximab Switch - A Large Single-Centre Experience From the U.K.
Bibliographic record
Abstract
Introduction: The infliximab biosimilar (CT-P13) received market authorisation for inflammatory bowel disease in late 2016 with the aim of reducing cost and increasing access to therapy. The prospect of “switching” patients from originator to biosimilar Infliximab is still concerning to clinicians. We present an experience of “switching” from originator infliximab(IFX-O) to CT-P13 and present efficacy and safety data from our cohort. Methods: We performed a retrospective review of patients who were switched from IFX-O to CT-P13 at our centre. Disease demographics, clinical course and outcomes were analysed from electronic case records until last follow-up. Results: Ninety-six patients (35 female) were “switched” from IFX-O to CT-P13. Of these 44 had Ulcerative colitis (UC) and 52 had Crohn's disease (CD) with mean age at diagnosis of 34.73 years (median = 33, IQR = 24.5). Montreal phenotype for UC was E1 = 1, E2 = 16, E3 = 27 and for CD (A1 = 8,A2 = 23,A3 = 21),(L1 = 10,L2 = 12, L3 = 29,L4 = 1) and ( B1 = 27, B2 = 14, B3 = 11), 9 patients had perianal disease. Mean duration of IFX-O treatment was 49.8months (median = 44, IQR = 52) and on CT-P13 s 7.9 months (median 8). Seventy six patients had a normal CRP (UC = 33, CD = 43), and in 15 patients it was elevated (UC = 10, CD = 5) at the time of switching. Eighty patients remained in biochemical remission (UC = 35, CD = 45) and in 14 patients (UC = 8,CD = 6 ) CRP increased at follow-up. Likewise, 19 patients had a faecal calprotectin at switch which remained normal in 16. Therapeutic drug monitoring was performed in 31 patients on CT-P13 .Of f these 28 patients maintained IFX within therapeutic range, 3 patients had sub-therapeutic IFX levels (< 4) and required dose intensification. At last follow up 72 patients ( UC = 34, CD = 38 ) were in clinical remission ( pMayo < 2 and HBI < 5) Mucosal assessment was performed in 51 patients (UC = 21, CD = 30) of which 31 achieved mucosal healing ( UC = 13, CD = 18). Conclusion: Biosimilar IFX (CT-P13) was well tolerated and maintained efficacy of IFX in patients who underwent a “switch” from originator IFX. This holds promise for a wider adoption of “switching” to fulfill the purported aims of improving access to treatment and reducing cost.
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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 | 0.004 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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".