4CPS-141 Indirect comparison of risankizumab versus upadacitinib for the maintenance of moderate to severe crohn’s disease
Bibliographic record
Abstract
Background and Importance Risankizumab has recently been approved for use in patients with moderate to severe Crohn’s disease (msCD). There is a direct comparison between risankizumab and ustekinumab, but the clinical benefit versus upadacitinib is unknown. Aim and Objectives The aim of this study was to perform an indirect treatment comparison (ITC) of the efficacy during the maintenance phase of risanlizumab and upadacitinib in patients with msCD using a common comparator, and to establish whether both treatments can be declared equivalent therapeutic alternatives (ETA). Material and Methods A bibliographic search was conducted in MEDLINE-Pubmed to identify phase III clinical trial (CTs), with similar population and with the same variable, which could allow comparison between risanlizumab and upadacitinib. The clinical remission (CR) beteween week 44–52 was used as the main variable. An ITC was performed using the Bucher method, using the Indirect Treatment Comparisons calculator from the Canadian Agency for Health Technology. Delta value (D, maximum difference as a clinical criterion of equivalence) was calculated using the reference value used for the sample calculation in the clinical trial of risankizumab vs ustekinumab (absolute risk reduction (ARR)=10%). To establish the positioning, ETA guidelines were applied. Results A total of 3 CTs were included in the ITC: SEQUENCE (risanlizumab 360mg every 8 week vs ustekinumab 90mg every 8 week), IM-UNITI (ustekinumab 90 mg every 8 week vs placebo) and U-ENDURE (upadacitinib 30mg every 24 hours vs placebo). The results of each trial and the conducted ITC are summarised in table 1. Applying the ETA guidelines, both treatments can be declared ATE, as the probability of clinically relevant difference is minus 50%, and the failure does not involve serious/irreversible damage. Conclusion and Relevance ITC showed no statistically significant differences in CR between risankizumab and upadacitinib. According to the ETA guidelines, as the percentage outside the delta margin was small, both drugs could be considered as ETA in most patients with msCD during the maintenance phase. References and/or Acknowledgements Conflict of Interest No conflict of interest
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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 | 0.008 | 0.015 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.005 | 0.014 |
| Bibliometrics | 0.003 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.027 | 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".