P247 Comparison of discontinuation/switching between infliximab biosimilar and originator among Inflammatory Bowel Disease patients: a real-world analysis of two Canadian cohorts
Bibliographic record
Abstract
Abstract Background Biosimilar infliximab (INF-B) has been approved in Canada for Inflammatory Bowel Disease (IBD) for over five years, but real-world descriptions of therapy persistence (discontinuation/switching) comparing INF-B to bio-originator (INF-O) are still scarce. Our objectives are to describe and compare therapy discontinuation/switching of INF-B and INF-O in IBD. Methods We used data from two IBD tertiary care clinics in Canada, in Montreal (QC) and Hamilton (ON). We studied biologic-naïve and biologic-experienced IBD adult initiating INF-B or INF-O between Jan. 2015 and Jul. 2020. We assessed time to discontinuation/switching through Kaplan-Meier curves (right-censoring due to loss to follow-up or end of the observation period). Reasons for discontinuation were assessed. Multivariable Cox regression models were performed to assess difference in time to discontinuation/switching between the two infliximab types. Model variables included age at infliximab initiation, sex, underlying condition (Ulcerative Colitis or Crohn’s Disease), disease duration, race/ethnicity, calendar year of infliximab start, current smoking, clinical centre, and previous use of other biologics, as well as previous/current use of corticosteroids, non-biologic immunosuppressants, budesonide, or 5-aminosalicylates. Results We studied 306 patients followed an average of 1.4 (standard deviation, SD=0.99) years. Patients were 46.7% female, with median age at infliximab initiation of 32 (interquartile range, IQR 21 to 47) years and median disease duration of 3.5 (IQR 0.9 to 11.7) years. Age, sex, and other baseline characteristics were comparable between the two groups, though there was a trend towards more INF-B initiation in recent years (Table 1). We identified 70 discontinuation/switching events; the main reasons for discontinuation/switching were adverse events (37.1%) and secondary loss of response (28.6%). The median time to discontinuation/switching was 4.1 (95% confidence interval, CI 3.4–5.5) years among INF-O and 3.0 (95% CI 2.2–3.5) years in the INF-B group. In the multivariate model, risk of the main outcome was not clearly different between the two groups (hazard ratio, HR 1.21, 95% CI 0.64–2.32 – Table 2). Older age and corticosteroids were significantly associated with discontinuation/switching of the initial infliximab therapy. Conclusion In this real-world analysis, we were unable to demonstrate differences in risk of discontinuation/switching among initiators of infliximab biosimilar or originator in IBD.
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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 | 0.001 | 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) | 0.000 | 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".