S867 Ozanimod for Moderate-to-Severe Ulcerative Colitis: Results From the North American Population During Induction and Maintenance in the Phase 3 True North Study
Bibliographic record
Abstract
Introduction: True North was a phase 3, randomized, double-blind (DB), placebo (PBO)-controlled trial conducted at 285 sites in 30 countries (NCT02435992). Treatment with once-daily ozanimod (an oral sphingosine 1-phosphate [S1P] receptor modulator selectively targeting S1P1 and S1P5) in patients (pts) with moderately-to-severely active ulcerative colitis (UC) showed significant improvements in primary and all key secondary endpoints. Here we report findings on the consistency of clinical and endoscopic endpoints in the global and North American population. Methods: In True North, pts received either DB treatment with ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching PBO, or open-label ozanimod 1 mg over a 10-week (wk) induction period. Pts with clinical response to ozanimod at wk 10 were re-randomized 1:1 to receive DB maintenance treatment with ozanimod 1 mg or PBO through wk 52. The primary endpoint was proportion of pts in clinical remission at wks 10 and 52; key secondary endpoints included clinical response and endoscopic improvement. The global population included 1012 pts who received at least 1 dose of study medication during induction, and 457 who received at least 1 dose of study medication during maintenance. Here, we examine results from pts in North American sites. Results: A total of 247 pts were enrolled in North America, of which 167 received DB ozanimod (n=107) or PBO (n=60) during induction. At baseline, 41.1% and 48.3% of pts in the ozanimod and PBO groups, respectively, had previously received a biologic treatment for UC. At wk 10, 15.9% and 3.3% of pts in the ozanimod and PBO groups, respectively, achieved clinical remission. In addition, greater proportions of pts achieved clinical response and endoscopic improvement with ozanimod at wk 10 (Table 1). During maintenance, 105 pts from North America were re-randomized to treatment with ozanimod (n=56) or PBO (n=49). At wk 52, 39.3% and 12.2% of pts in the ozanimod and PBO groups, respectively, achieved clinical remission, and greater proportions of pts achieved clinical response and endoscopic improvement with ozanimod (Table 1). These outcomes from the North American population are consistent with those previously reported from the global population. Conclusion: In this post-hoc analysis, consistent with the global population, ozanimod treatment for up to 52 wks in North American pts with moderately-to-severely active UC showed benefits on clinical and endoscopic endpoints.Table 1.: Efficacy Outcomes from the North American Participants in True North.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| 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 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".