Long-term efficacy of ozanimod up to 3 years in patient response subgroups identified using group-based trajectory modelling
Bibliographic record
Abstract
Background: Ozanimod is approved in multiple countries for the treatment of adults with moderately to severely active ulcerative colitis (UC). A previous post hoc analysis of individual outcomes in the phase 3 True North trial (NCT02435992) identified 5 groups of patient-response trajectories to ozanimod using group-based trajectory modeling (GBTM) and found that populations with fast response had higher rates of disease control, including patient-reported intestinal symptoms and objective measures of disease activity. Objectives: This analysis of the True North open-label extension study (OLE; NCT02531126) evaluated the durability of ozanimod in the 5 groups for up to 3 years in the OLE (Week [W] 142). Methods: In patients who entered the OLE from the 5 patient groups (Group 1 [super-response], Group 2 [sustained improvement], Group 3 [partial improvement], Group 4 [fast rebound], and Group 5 [slow rebound]), symptomatic endpoints were evaluated throughout the OLE until W142. Clinical and mucosal endpoints were evaluated at OLE W46, W94 and W142. Efficacy endpoints were evaluated using nonresponder imputation analysis. Results: The percentage of patients who continued into the OLE was similar among the 5 trajectory groups, but higher proportions of patients in Groups 1–3 completed W52 before entering the OLE (Group 1 [84.2%], Group 2 [85.9%], Group 3 [86.7%], Group 4 [32.0%], and Group 5 [28.6%]). Notably, more patients from Groups 1 (60.6%), 2 (62.3%), and 3 (60.0%) completed OLE W142 than those in Groups 4 (20.0%) and 5 (26.3%). More patients in Groups 1–3, with the highest rates in Group 1, retained symptomatic response and remission through OLE W142 with continuous ozanimod treatment compared with those in Groups 4 and 5 ([ Fig. 1 ] [ 2 ]). Higher proportions of patients in Groups 1–3 achieved and sustained response in all clinical and mucosal outcomes at OLE W46, W94, and W142 compared with Groups 4 and 5 (Table). Fig. 1 Fig. 2 Conclusions: This analysis showed that personalized patient trajectory response-based modeling distinguished patients in terms of long-term outcomes. Specifically, patients with more robust patterns of response (Groups 1–3, especially Group 1) had higher sustained rates of symptomatic, clinical, and mucosal efficacy for up to 3 years of ozanimod treatment in the OLE than patients with less robust response patterns (Groups 4 and 5). Publication History Article published online: 26 September 2024 © 2024. Thieme. All rights reserved. Georg Thieme Verlag KG 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 | 0.005 | 0.010 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".