P51 Benefit-risk of upadacitinib in patients with moderately to severe ulcerative colitis (UC)
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
<h3>Introduction</h3> Here, key safety and efficacy data from the maintenance study of Upadacitinib (UPA) phase 3 clinical trial in UC are summarized. <h3>Aims and Methods</h3> Patients with a clinical response (per Adapted Mayo score) after 8 weeks induction with UPA 45 mg OD were re-randomized in maintenance to receive UPA 15 mg OD, UPA 30 mg OD, or placebo (PBO). For efficacy outcomes, point estimates and 95% confidence intervals (CI) of the PBO-adjusted treatment effect were calculated. For the risk analysis, exposure-adjusted event rates (events per 100 patient-years [E/100 PY]) were evaluated. <h3>Results</h3> Primary endpoint of clinical remission at Week 52 were 30.1% (95% CI: 22.7, 37.4) with UPA 15 mg and 42.9% (35.4, 50.4) with UPA 30 mg (p<0.001 for both; <b>table 1</b>). All secondary endpoints were significantly different. Serious infections were 5.9 E/100 PY with PBO vs 5.0 and 3.2 with UPA 15 mg and30 mg, respectively. Herpes Zoster with UPA 15 mg and 30 mg were 6.0 and 7.3 E/100 PY, respectively versus 0 in placebo. Malignancy excluding non-melanoma skin cancer were 0.7 E/100 PY with PBO vs 0.5 and 0.9 with UPA 15 mg and 30 mg, respectively; non-melanoma skin cancer were 1.4 E/100 PY with UPA 30 mg, with no cases with UPA 15 mg or PBO. Venous thromboembolic events were low in the UPA groups with no cases reported in PBO (<b>table 1</b>). <h3>Conclusion</h3> Response rates were significantly greater with UPA 15 mg and 30 mg versus PBO across all endpoints. Generally, both UPA doses were well tolerated and have a favorable benefit-risk profile after 52 weeks’ maintenance. The safety of UPA will continue to be monitored.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| 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 | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 it