P601 Upadacitinib improves steroid-free clinical and endoscopic endpoints in patients with Crohn’s disease: Data from the CELEST study
Bibliographic record
Abstract
The efficacy and safety of upadacitinib (UPA), an oral selective JAK1 inhibitor, were assessed in patients with moderate-to-severe Crohn’s disease (CD) and with inadequate response/intolerance to an immunomodulator or tumour necrosis factor inhibitor (TNFi).1 We report the steroid-free endpoints in the 16-week induction phase of CELEST in patients receiving corticosteroid (CS) at baseline (BL). Patients with CD Activity Index (CDAI) 220–450, average daily very soft/liquid stool frequency (SF) ≥2.5 or abdominal pain score (AP) ≥2.0 and Simplified Endoscopic Score for CD (SES-CD) ≥6 (or ≥4 for those with isolated ileal disease) were randomised equally to receive either placebo (PBO) or UPA 3, 6, 12, 24 mg twice daily (BID) or 24 mg once daily (QD) for 16 weeks. Patients were also randomised 1: 1 at BL for follow-up ileocolonoscopy at either 12 or 16 weeks. Beginning at Week 2, CS was tapered in patients on CS at BL. The proportion of patients who discontinued CS and achieved endoscopic remission, endoscopic response, clinical remission, modified clinical remission (all defined in Figure), and CDAI <150 were assessed at Week 16 in patients on CS at BL. Patients with missing data or who prematurely discontinued or received CS dose higher than BL were considered non-responders. Comparisons of each dose of UPA vs. PBO were performed using Chi-square test. Treatment-emergent adverse events (AEs) collected throughout the study in patients with at least one UPA dose up to 30 days of the last dose were stratified by CS use at BL. Among 220 randomised patients, 96 (43.6%) received CS at BL: median (min–max) age 38.5 (19.0–69.0) years, CDAI 291.0 (162–599), CD duration 9.4 (0.1–44.7) years and 95 (99.0%) had failed one or more TNFi. More patients taking UPA were able to discontinue CS and achieve endoscopic endpoints at 12 of 16 weeks and clinical endpoints at 16 weeks than patients on PBO (Figure). Patients on 24 mg BID achieved a statistically significant difference from PBO in all clinical remission endpoints. The rates of any AEs were similar between patients with or without CS use in the UPA (85.2% and 80.4%, in all UPA arms, respectively) and PBO groups (73.3% and 72.7%). Proportion of subjects who discontinued corticosteroid and achieved clinical and endoscopic endpoints at 16 weeks. Patients with long-standing CD refractory to conventional/TNFi therapy who received CS at BL achieved statistically significant steroid-free endoscopic and clinical improvements at 16 weeks of treatment with UPA. The safety profile of UPA in patients taking CS at BL was consistent with the overall study population. 1. Sandborn WJ et al. Gastroenterology 2017;152(Suppl. 1):S1308–9.
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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 | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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".