P687 Clinical remission demonstrated with oral ozanimod in the overall population and across multiple subgroups of patients with moderately to severely active ulcerative colitis in the TOUCHSTONE trial
Bibliographic record
Abstract
Ozanimod is an oral immunomodulator that selectively targets S1P1 and S1P5. TOUCHSTONE, a randomised, double-blind, placebo-controlled phase 2 trial that evaluated patients with moderately to severely active ulcerative colitis (UC) showed significantly higher rates of clinical remission, clinical response, and endoscopic mucosal healing (Mayo endoscopic subscale score of 0/1) at Weeks 8 and 32 in patients assigned to ozanimod 1 mg compared with those who received placebo (Sandborn et al., NEJM, 2016).1 Clinical remission at Week 32 also was assessed across subgroups of interest. Patients were randomised 1:1:1 and received ozanimod 1 mg, ozanimod 0.5 mg, or placebo. Mayo score, based on stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician rating of disease activity was calculated at baseline, end of induction (Week 8), and end of maintenance (Week 32). Clinical remission was defined as total Mayo score ≤2, with no subscore >1. A post hoc sub-group analysis evaluated clinical remission rates at Week 32 according to baseline Mayo score, years since UC diagnosis, and body mass index (BMI). A total of 197 patients were randomised to ozanimod 1 mg (n = 67), 0.5 mg (n = 65), or placebo (n = 65), with 103 (52.3%) entering a maintenance period based on response criteria and 91 (88.3%) completing the study. Differences in the proportion of patients in clinical remission with ozanimod 1 mg vs. placebo by subgroup illustrate that the treatment effect favoured ozanimod 1 mg in every subgroup analysed (see Figure 1). Forest plot of clinical remission at Week 32 in the overall population and by subgroup (ITT population, non-responder imputation) – RPC1063 1 mg vs. placebo. The 95% confidence intervals for the treatment difference between ozanimod 1 mg and placebo exclude 0 for the overall population and subgroups of baseline Mayo score >8, years since UC diagnosis >6, and BMI >21. In the TOUCHSTONE trial, ozanimod therapy was consistently more efficacious than placebo for induction of clinical remission across a wide range of patient subtypes including those with relatively long disease duration and high disease activity. References 1. Sandborn WJ, Feagan BG, Wolf DC, et al. Ozanimod induction and maintenance treatment for ulcerative colitis. N Engl J Med 2016.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".