P337 Switching from originator infliximab to CT-P13: single-centre experience from the UK
Bibliographic record
Abstract
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 CT-P13 has concerned clinicians. #8232;We present an experience of ‘switching’ from originator infliximab (IFX-O) to CT-P13 and present efficacy, safety, and immunogenicity data from our cohort. We performed a retrospective review of patients switched from IFX-O to CT-P13. Disease demographics, clinical course and outcomes were analysed from electronic case records at a median of 8 months and at last follow-up at 13 months. Ninety-six patients (35 females) were ‘switched’ from IFX-O to CT-P13. Of these 44 had Ulcerative colitis (UC) and 52 had Crohn’s disease (CD) with a mean age at diagnosis of 34.7 years (median = 33, IQR = 24.5). Montreal phenotype for UC was E1 = 1, E2 = 16, E3 = 27 and for CD (L1 = 10, L2 = 12 , L3 = 29, L4 = 1) and (B1 = 27, #8232;B2 = 14 , B3 = 11), 9 patients had perianal disease. Mean duration of IFX-O treatment was 49. 8 months (median = 44, IQR = 52) and on CT-P13 11.5 months (median 13). At switch, 76 patients had a normal CRP (UC = 33, CD = 43), and in 15 patients it was elevated (UC = 10, CD = 5). At 8 months, 80 patients remained in biochemical remission (UC = 35, CD = 45 ) and in 14 patients (UC = 8, CD = 6 ) CRP increased. Seventy-two patients (UC = 34, CD = 38 ) were in clinical remission (pMayo < 2 and HBI < 5). Of 51 patients (UC = 21, CD = 30) undergoing endoscopic assessment, 31 achieved mucosal healing (UC = 13, CD = 18). At 13 months, 69 patients remained on CT-P13. Twenty-seven discontinued the drug due to immunogenicity (n = 10), loss of response (n = 5), surgery (n = 5), remission (n = 5) , side effects (n = 2 ), and 1 patient died of hospital acquired pneumonia. 39 out of 96 patients had therapeutic drug levels checked within 13 months of switch, of whom 27 had sub-therapeutic levels (below 4 μg/ml). Antibodies to Infliximab were seen in 15 of 39 patients (38.5%), of whom 8 were switched to an alternative biologic, 2 had dose escalation (10 mg/kg IFX), 4 patients stopped IFX with no other intervention, and 1 person continued treatment at same dose with low antibody titre of 6. Biosimilar IFX (CT-P13) was well tolerated. Clinical efficacy and loss of response rates with CT-P13 appears to be similar to IFX-O. This holds promise for a wider adoption of ‘switching’ to fulfil the purported aims of wider access to treatment at a lower 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 | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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 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".