Comparative Efficacy of Mesalazine and Ozanimod following Induction Treatment in Mesalazine-Exposed Advanced Therapy-Naïve Adult Ulcerative Colitis Patients
Bibliographic record
Abstract
Introduction: Both mesalazine and ozanimod are oral treatment options for patients with moderately active ulcerative colitis (UC). Methods: Comparative analysis comparing efficacy endpoints of an 8-week non-inferiority induction study (TP0503) with 3.2 g/day mesalazine (n = 321) to the True North 10-week induction study of 1 mg/day ozanimod (n = 281). We compared the efficacy of oral mesalazine (Asacol) as monotherapy and ozanimod (Zeposia) as add-on therapy to mesalazine, without concomitant corticosteroids, following induction treatment in mesalazine-exposed but immunomodulator- and advanced therapy-naïve UC patients. Endpoints from the non-inferiority study were re-calculated using the definitions from the True North study. Results: The two cohorts had similar age (45 ± 14 years vs. 44 ± 13.5 years) and baseline disease severity (total Mayo score; 8.5 ± 0.8 vs. 8.6 ± 1.1) for mesalazine- and ozanimod-treated patients, respectively. No differences were observed in patients achieving clinical response (reduction from baseline in the 3-component Mayo score [sum of rectal bleeding subscore/RBS, stool frequency subscore/SFS, and Mayo endoscopic score/MES) of ≥2 points and ≥35%, and a reduction from baseline in the RBS of ≥1 point or an absolute RBS ≤1} (58% vs. 58%; p = 0.917) and clinical remission (RBS = 0, SFS ≤1 [and decreases of ≥1 point from baseline SFS], and MES ≤1) (22% vs. 28%; p = 0.074) treated with mesalazine (at 8 weeks) and ozanimod (at 10 weeks), respectively. A higher percentage of patients treated with ozanimod achieved endoscopic improvement (MES ≤1 without friability) compared to mesalazine (38% vs. 29%, p = 0.018). Conclusion: Among individuals previously exposed to mesalazine, a similar effect on clinical efficacy was observed between patients treated with mesalazine and those treated with ozanimod.
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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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 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".