P120 Upadacitinib for moderate-to-severe ulcerative colitis: interim results from U-ACTIVATE phase III open-label extension
Bibliographic record
Abstract
Introduction Upadacitinib (15 mg [UPA15] or 30 mg [UPA30] once daily) demonstrated efficacy vs placebo after 52 weeks (wks) of maintenance therapy in the U-ACHIEVE Maintenance study.1 2 Methods This interim analysis presents efficacy and safety data from patients (pts) receiving UPA15 or UPA30 for an additional 48 wks (~2 years total) in the ongoing, 288-wk, long-term extension (LTE) study U-ACTIVATE. Pts with dose adjustments at wk 48 of the LTE study were excluded from this analysis. Safety during U-ACTIVATE was assessed throughout. Results U-ACTIVATE interim analysis included 101 pts in UPA15 arm and 137 pts in UPA30 arm. At wk 48, clinical remission per adapted Mayo Score (aMS) was similar for UPA15 and UPA30 (78.2% [68/87] and 77.3% [92/19], respectively), as was clinical remission per partial Mayo Score (pMS) (92.4% [85/92] and 90.9% [110/121], respectively) and clinical response per aMS (97.7% [85/87] and 95.8% [114/119], respectively). Endoscopic endpoints were also similar between the groups, with maintenance of endoscopic remission numerically higher in UPA30 (81.1%, 43/53) vs UPA15 (71.8%, 28/39). The 238 pts included in the safety analysis achieved 426.5 pt-years (PYs) of exposure (UPA15, 186.0; UPA30, 240.5). Exposure-adjusted event rates (EAERs) of serious treatment-emergent adverse events (TEAEs) and TEAEs leading to treatment discontinuation were similar in both groups. No deaths occurred in either group. The EAERs for TEAEs of special interest were generally lower with UPA15 vs UPA30, including for serious infections, herpes zoster, neutropenia and creatine phosphokinase elevation. EAER for hepatic disorder was higher with UPA15 vs UPA30 (8.6 vs 4.2 Events/100PY, respectively). No adjudicated major adverse cardiovascular events occurred; no adjudicated venous thromboembolic events occurred with UPA15 and one with UPA30. One event of malignancy excluding non-melanoma skin cancer occurred in both UPA15 and UPA30. Conclusions Achievement of clinical and endoscopic endpoints observed with UPA15 and UPA30 after the 52-wk maintenance study1,2 was sustained through wk 48 of the LTE study. The safety profile of UPA was consistent with previous analyses. References Danese S, et al. Lancet 2022;399:2113–28. Vermeire S, et al. Presented at UEGW [OP001], 8–11 October 2022.
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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 | 0.002 |
| 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 | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".