S712 Benefits of High versus Low Dose Upadacitinib as Maintenance Treatment in Ulcerative Colitis Patients Who Were Responders to 8-week Induction with Upadacitinib: Results From the U-ACHIEVE Phase 3 Maintenance Trial
Bibliographic record
Abstract
Introduction: Evaluate the benefits of upadacitinib (UPA) 30mg (UPA30) vs 15mg (UPA15) once daily (QD) as maintenance treatment in patients (pts) with active ulcerative colitis (UC). Methods: This post-hoc analysis included pts with clinical response after 8 wks of induction (16-wk induction responders were excluded) with UPA 45mg QD who were enrolled in U-ACHIEVE maintenance trial and re-randomized 1:1:1 to UPA15, UPA30, or placebo (PBO) QD for 52 wks. Clinical remission per Partial Adapted Mayo score were evaluated in subgroups of pts with mild (Adapted Mayo score < 5), moderate (Adapted Mayo score 5 to ≤7), or severe (Adapted Mayo score >7) UC at wks 0 and 52 of maintenance. For each UPA dose, area under the curve (AUC) analysis on proportion of pts in clinical remission per Partial Adapted Mayo score at wks 0, 4, 8, 12, 20, 28, 36, 44 and 52 of maintenance was used to calculate the number of wks pts were in clinical remission. To assess these benefits in the non-elder population, analysis was replicated for UPA doses in pts < 65 years. Results: Data from 451 pts (UPA15, n=149; UPA30, n=148; PBO, n=154) were analyzed. At Wk 0 of maintenance, at least 91% of pts had mild disease and no pts had severe disease across treatment groups (Table). At the end of 52-wks maintenance, 19.7% more UPA30 pts were in lesser disease severity (10.5% and 9.2% more pts with mild and moderate disease, respectively) vs UPA15. Based on AUC analysis, PBO pts, UPA15 and UPA30 pts were in clinical remission for 15.8 (95% CI: 12.2, 19.5), 30.5 (95% CI: 26.4, 34.6), and 34.4 (95% CI: 30.5, 38.3) wks, respectively. UPA30 pts were in clinical remission for an additional 3.8 wks (26.9 days) over a year of maintenance vs UPA15. In pts < 65 years old (n=411), 26% more UPA30 pts were in lesser disease severity (14% and 12% more pts with mild and moderate disease, respectively) vs UPA15 and were in clinical remission for an additional 4.2 wks (29.3 days) over a year of maintenance vs UPA15. Conclusion: After 52-wks of maintenance treatment with UPA 30mg QD, pts had less severe disease and were in clinical remission for approximately 1 additional month/year vs pts treated with UPA 15mg QD indicating clinical benefit of high dose UPA as maintenance treatment in UC. Table 1. - Patients with mild, moderate, and severe UC at Weeks 0 and 52 and weeks in clinical remission Patients with mild, moderate, and severe UC at Weeks 0 and 52 and weeks in clinical remission Week 0 Week 52 a Weeks in Clinical Remission b n (%) N Mild Moderate Severe Mild Moderate Severe Mean (95% CI) PBO 149 137 (92.0) 12 (8.1) 0 34 (22.8) 70 (47.0) 45 (30.2) 15.8 (12.2, 19.5) UPA 15 mg 148 136 (91.9) 11 (7.4) 0 94 (63.5) 25 (16.9) 28 (18.9) 30.5 (26.4, 34.6) UPA 30 mg 154 141 (91.6) 13 (8.4) 0 114 (74.0) 24 (15.6) 15 (9.7) 34.4 (30.5, 38.3) aPatients with Adapted Mayo scores collected at or after initiation of UC-related rescue medications through the end of the maintenance study or who prematurely discontinued from the study were assumed to have Week 52 Adapted Mayo score return to baseline. Patients with missing data for reasons other than UC-related rescue medications or premature discontinuation were handled by last observation carried forward. Disease severity was defined by Adapted Mayo score: mild (Adapted Mayo < 5), moderate (Adapted Mayo 5 to ≤7), and severe (Adapted Mayo >7).bClinical remission was defined as Partial Adapted Mayo score ≤2 with no subscore >1.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| 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".