Long-term use of ozanimod in patients with moderately to severely active ulcerative colitis
Bibliographic record
Abstract
Introduction Ozanimod is approved in Europe and the United States to treat patients (pts) with moderately to severely active ulcerative colitis (UC) based on results from the 52-week (wk) phase 3 True North (TN) study. Objectives This interim analysis evaluated long-term efficacy and safety of ozanimod in the ongoing TN open-label extension (OLE). Methods Pts entered the OLE from the TN parent study if they were non-responders after induction, lost response during maintenance, or completed maintenance. Clinical remission, clinical response, endoscopic improvement, and corticosteroid-free remission were evaluated at OLE Wks 46, 94, and 142 for all pts who entered from the TN parent study, and in the subset of TN pts in clinical response at OLE entry. Partial Mayo score was assessed at every visit. Data were analysed in the intent-to-treat population using observed cases (OC; pts remaining in the study at the corresponding time point) and non-responder imputation (NRI; pts remaining in the study at the corresponding time point and those who withdrew before the time point but would have reached it had they stayed). Treatment-emergent adverse events were evaluated from pooled UC studies. Results A total of 823 pts from TN entered the OLE; as of the cutoff date (30 Sept 2020), 64% completed Wk 46, 34% completed Wk 94, and 14% completed Wk 142 of the OLE. The most common reason for discontinuation was lack of efficacy (21%). Baseline demographics were similar to the TN study. A total of 261 pts were in clinical response at OLE entry. In the OC analysis, efficacy was maintained over time and was higher in responders vs the totalpopulation. Clinical response was achieved in 80%, 84%, and 86% of pts at OLE Wks 46, 94, and 142, respectively, and in 95% and 98% at OLE Wks 46 and 94 in pts entering the OLE in clinical response. Using the more conservative NRI analysis, the proportion of pts achieving each endpoint was lower than in the OC; however, 34% of all pts and 55% of responders maintained clinical response at Wk 94. Partial Mayo scores declined by Wk 5 and remained low for the duration of the OLE in the total population and in the responders. No new safety signals were seen with long-term ozanimod use in the pooled population (N=1158). Conclusion UC pts from the TN study demonstrated maintenance of response with long-term ozanimod treatment. These data reflect approximately 2 years of additional ozanimod treatment, with no new safety signals identified. Publication History Article published online: 19 August 2022 © 2022. Thieme. All rights reserved. Georg Thieme Verlag Rüdigerstraße 14, 70469 Stuttgart, Germany
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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 source (direct Gemma or distilled Codex), 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".