Upadacitinib Maintenance Therapy in Crohn’s Disease: Final Results From the Randomized Phase 3 U-ENDURE Study
Bibliographic record
Abstract
BACKGROUND & AIMS: Upadacitinib, an oral, reversible Janus kinase inhibitor, demonstrated efficacy and safety in patients with Crohn's disease in 2 phase III induction trials (U-EXCEL and U-EXCEED) and in a primary analysis of the first 502 patients entering the subsequent maintenance trial (U-ENDURE). Here, we present the overall results of the entire population of U-ENDURE (N = 673). METHODS: Clinical responders to 12 weeks of upadacitinib 45 mg once daily (QD) induction were randomized (1:1:1) to receive upadacitinib 15 mg QD (n = 221), upadacitinib 30 mg QD (n = 229), or placebo (n = 223) as maintenance therapy for 52 weeks. Coprimary endpoints were Crohn's Disease Activity Index (CDAI) clinical remission and endoscopic response at week 52. Safety was assessed through week 52. RESULTS: At week 52, more upadacitinib-treated vs placebo patients achieved CDAI clinical remission (upadacitinib 15 mg, 36.2% and upadacitinib 30 mg, 51.5% vs placebo, 15.2%). The rates of endoscopic response were 27.3% for upadacitinib 15 mg and 40.7% for upadacitinib 30 mg vs 7.2% for placebo. Exposure-adjusted event rates for treatment-emergent adverse events were numerically lower with upadacitinib 15 mg and 30 mg vs placebo (351.3 and 324.5 per 100 patient-years, respectively, vs 462.8 per 100 patient-years) except for COVID-19 and adverse events leading to early discontinuation of study treatment. No deaths, active tuberculosis, lymphoma, nonmelanoma skin cancer, adjudicated major cardiovascular adverse events, or venous thromboembolic events were reported from any treatment group. Herpes zoster infections occurred more frequently in the upadacitinib groups compared with placebo; all were nonserious, and most involved a single dermatome. CONCLUSIONS: Consistent with the primary analysis, upadacitinib was more efficacious than placebo in achieving clinical and endoscopic endpoints in patients with Crohn's disease. The safety profile remained consistent with no new safety signals. CLINICALTRIALS: gov Number: NCT03345823.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| 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".