Clinical outcomes and drug sustainability after non-medical switch from ustekinumab originator to biosimilars in inflammatory bowel disease
Bibliographic record
Abstract
BACKGROUND Biologic therapies have transformed the management of inflammatory bowel disease (IBD), yet their high cost poses substantial challenges for healthcare systems. Biosimilars offer a cost-effective alternative, with extensive evidence supporting the safety and efficacy of non-medical switching for infliximab and adalimumab. However, real-world data on ustekinumab biosimilars in IBD remain limited. Given increasing mandates for non-medical switches in Canada, evaluating clinical outcomes is critical to ensure patient safety and treatment sustainability. We hypothesized that switching from originator ustekinumab to a biosimilar would preserve clinical efficacy, safety, and drug persistence in patients with IBD. AIM To evaluate clinical efficacy, treatment persistence, biomarker activity, and adverse events in IBD patients who underwent non-medical biosimilar switching from the ustekinumab originator to a biosimilar. METHODS This was an observational study of consecutive IBD patients who underwent a biosimilar switch. Disease activity, biomarkers, drug sustainability, and adverse events were captured 8 weeks before the switch, at the time of switch (baseline), 12 weeks, and 24 weeks after the switch. RESULTS Of 81 patients were included [85.2% had Crohn’s disease, the median age at inclusion: 42 years (interquartile ranges: 29-61)]. Previous biological exposure was 82.7% and a dose optimization of the originator ustekinumab was performed in 63% before the switch. Drug sustainability at 12 weeks and 24 weeks of switch was 96.3% and 95%, regardless of disease type or phenotype. The discontinuation rate was 4.9%. There was no significant difference in the rates of clinical remission at week 8 before switch, baseline, week 12, and 24 after switch: 87%, 85.9%, 84.3%, and 92.7%, P = not statistically significant. The biomarker activity was not significantly different for C-reactive protein, hemoglobin, albumin, and fecal calprotectin (P = not statistically significant). All patients who stopped therapy after the non-medical switch needed a dose optimisation of the originator ustekinumab and had previous biological therapy prior to starting the ustekinumab originator. CONCLUSION Despite prior biologic exposure and frequent dose escalation, switching to ustekinumab biosimilar showed stable efficacy, unchanged biomarkers, and high treatment persistence.
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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 | 0.002 | 0.001 |
| 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 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 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 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".