O23 Risankizumab vs ustekinumab for patients with moderate-to-severe crohn’s disease: results from the phase 3b SEQUENCE study
Bibliographic record
Abstract
Introduction The Phase 3b SEQUENCE study directly compared efficacy and safety of risankizumab (RZB, IL-23p19 inhibitor), and ustekinumab (UST, IL-12/23p40 inhibitor), in patients (pts) with moderate-to-severe Crohn’s disease (CD). Methods SEQUENCE, an open-label, multicentre, randomised, efficacy assessment-blinded study, enrolled pts with moderate-to-severe CD who previously failed ≥1 anti-tumour necrosis factor (TNF) agents. In Part 1 of the trial, pts were randomised 1:1 to receive RZB (600 mg IV at weeks [wks] 0, 4 and 8, followed by 360 mg SC every 8 wks [Q8W] from wk12) or UST (single weight-based IV dose at wk0, followed by 90 mg SC Q8W from wk8) over 48 wks. Mandatory steroid tapering started at wk2. Primary endpoints were clinical remission at wk24 (non-inferiority of RZB vs UST in 50% of planned pts) and endoscopic remission at wk48 (superiority of RZB vs UST). Safety was assessed throughout. Results 255 (RZB) and 265 (UST) patients were assessed. The primary endpoints of the study were met. At wk24 clinical remission (CD Activity Index <150) rates were 58.6% (75/128) for RZB and 39.5% (54/137) for UST (D18.4, non-inferiority met with the pre-defined margin of 10% in 50% of enrolled patients). At wk48, endoscopic remission rates were 31.8% (81/255) for RZB and 16.2% (43/265) for UST (D15.6%, p<0.0001 for superiority). RZB was superior to UST for all secondary endpoints (all p<0.0001). Exposure-adjusted adverse event (AE) rates (Events [E/100PYs]) were comparable between RZB (879 [341.2]) and UST (763 [282.7]). Serious AEs and AEs leading to discontinuation were numerically higher with UST vs RZB. Conclusions RZB demonstrated non-inferiority to UST for wk24 clinical remission, superiority for wk48 endoscopic remission, and superiority in secondary endpoints in moderate-to-severe CD refractory to anti-TNFs. RZB and UST were well tolerated.
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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 | 0.003 | 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 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| 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".