S852 Long-Term Clinical and Endoscopic Outcomes in True North Week 52 Clinical Remitters Over 3 Years of Treatment With Ozanimod: An Interim Analysis of the True North Open-Label Extension Study
Bibliographic record
Abstract
Introduction: Ozanimod (OZA), a selective sphingosine 1-phosphate receptor modulator, is approved for the treatment of moderately to severely active ulcerative colitis (UC) based on results from the phase 3 True North (TN) study, which demonstrated the efficacy and safety of OZA over 52 weeks. A subsequent post hoc analysis demonstrated the durability of OZA efficacy and favorable safety profile of OZA over 3 years during the ongoing TN OLE in patients with UC who achieved clinical response at TN Week (W) 52. Methods: The present interim analysis of the TN OLE expands the evaluation of TN W52 clinical responders to include those who achieved clinical remission at TN W52 (ie, clinical remitters) vs those who did not (ie, clinical nonremitters) before entering the TN OLE. Clinical remission, clinical response, endoscopic improvement, and corticosteroid (CS)–free remission were evaluated in TN W52 clinical remitters vs nonremitters at OLE W46 and OLE W94 using observed case (OC) and nonresponder imputation (NRI) analyses. Results: In all, 131 patients entered the OLE as TN W52 clinical responders on continuous OZA therapy; of these patients, 63% (83/131) were clinical remitters. All patients had received 146 weeks of continuous OZA treatment up to OLE W94 or discontinued treatment. TN baseline demographic and disease characteristics were generally similar between the 2 groups, but a lower incidence of prior tumor necrosis factor (TNF) inhibitor use was reported in clinical remitters (25.3% [21/83]) vs clinical nonremitters (43.8% [21/48]); prior non–anti-TNF biologic use was similar between groups. Compared with clinical nonremitters, more clinical remitters achieved the evaluated efficacy endpoints at OLE W46 and OLE W94 in the OC analysis (Table 1). A similar trend was observed in the NRI analysis. Durability of response for all efficacy endpoints was sustained from OLE W46 to OLE W94 in most clinical remitters and nonremitters, respectively: 68.5% (37/54) and 75.0% (12/16); clinical response: 75.0% (48/64) and 75.9% (22/29); endoscopic improvement: 66.1% (41/62) and 68.4% (13/19); and CS-free remission: 67.9% (36/53) and 80.0% (12/15). Conclusion: Most patients who achieved clinical remission after 1 year of OZA had sustained efficacy for an additional 2 years of continuous OZA treatment. These findings provide further evidence for the long-term durability of OZA treatment in patients with moderately to severely active UC. Table 1. - OZA efficacy at OLE W46 and OLE W94 in TN W52 clinical responders with or without clinical remission (OC analysis) Clinical remitters at TN W52 (n=83) Clinical nonremitters at TN W52 (n=48) OLE W46 OLE W94 OLE W46 OLE W94 Clinical remission,a % (n/N) 97.0 (64/66) 94.4 (51/54) 93.5 (29/31) 85.2 (23/27) Clinical response,b % (n/N) 81.8 (54/66) 75.9 (41/54) 51.6 (16/31) 55.6 (15/27) Endoscopic improvement,c % (n/N) 86.1 (62/72) 78.6 (44/56) 59.4 (19/32) 63.3 (19/30) CS-free remission,d % (n/N) 80.3 (53/66) 74.1 (40/54) 48.4 (15/31) 55.6 (15/27) Note: Denominators for the OC analyses were based on the numbers of patients who completed OLE W46 or OLE W94 and had data available for the endpoints in question.aClinical remission: RBS=0 point and SFS ≤1 point, a decrease of ≥1 point from the baseline SFS, and endoscopy subscore ≤1 point.bClinical response: reduction from baseline in the 9-point Mayo score (sum of the RBS, SFS, and endoscopy subscore) of ≥2 points and ≥35%, and a reduction from baseline in the RBS of ≥1 point or an absolute RBS of ≤1 point.cEndoscopic improvement: endoscopy subscore of ≤1.dCS-free remission: clinical remission while off CS for ≥12 weeks.RBS, rectal bleeding subscore; SFS, stool frequency subscore.
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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 | 0.006 | 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 | 0.000 | 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".