P98 Efficacy and safety of 4 years of continuous ozanimod treatment: an interim analysis of the true north open-label extension study
Bibliographic record
Abstract
Introduction The phase 3 True North (TN) study (NCT02435992) demonstrated the efficacy and safety of ozanimod (OZA) over 52 wk in patients (pts) with moderately to severely active ulcerative colitis (UC). This interim analysis of the ongoing TN open-label extension (OLE; NCT02531126) assessed pts with up to ~4 y of OZA treatment. Methods Pts in clinical response at Week (W) 52 of OZA treatment during TN who subsequently entered the OLE were analyzed up to OLE W142, representing up to ~4 y of continuous OZA treatment. Symptomatic response and symptomatic remission were evaluated from OLE W5 through OLE W142. Clinical remission, clinical response, endoscopic improvement, and corticosteroid (CS)-free remission were evaluated at OLE W46, W94, and W142. Adverse events were monitored throughout TN and the OLE. Results In all, 131 pts entered the OLE after achieving clinical response on OZA at TN W52. At data cutoff, 64.1% completed OLE W142. Symptomatic response and symptomatic remission were observed in 100.0% and 84.4% of pts, respectively, at OLE W5 in observed case (OC) analyses (93.1% and 78.6%, respectively, in nonresponder imputation [NRI] analyses). By OLE W142, symptomatic response and symptomatic remission rates were 98.7% and 88.3%, respectively, in OC analyses (58.0% and 51.9%, respectively, in NRI analyses). Clinical and endoscopic endpoints are shown in figure 1. Of note, 65.3% of TN W52 clinical responders achieved clinical remission and CS-free remission at OLE W142 (OC analyses; 35.9% in NRI analyses). In the last year of follow-up in the OLE, there were no new bradycardia, third-degree atrioventricular block, hypertension, herpes zoster, or macular edema cases, and no clinically meaningful change in malignancy rates. No serious hepatic events occurred. Conclusions Clinical responders after 1 y on OZA sustained response for an additional 3 y and achieved clinical remission with continuous OZA exposure. OZA is a well-tolerated, durable therapy for pts with UC.
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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 | 0.004 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| 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) | 0.005 | 0.001 |
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".