P116 Primary efficacy and safety of mirikizumab in moderate to severe Crohn’s disease: results of the treat-through VIVID 1 study
Bibliographic record
Abstract
Objective Here we present primary efficacy and safety of mirikizumab (miri), a selective IL23p19 monoclonal antibody, compared to placebo (PBO) up to Week 52 (W52) in patients with moderate to severe Crohn’s disease from the Phase 3, randomised, double-blind, double-dummy, active- and PBO-controlled, treat-through VIVID-1 study. Methods Adult pts (N=1065) were randomized 6:2:3 to miri (N=579) 900mg intravenously (IV) at W0, W4, and W8, then 300mg subcutaneously (SC) every 4 weeks (Q4W) from W12 to W52, placebo (PBO) (N=199), or ustekinumab (N=287) ~6mg/kg IV at W0 and SC dose of 90mg Q8W from W8 to W48. Results 48.7% of pts in the PBO, and 48.5% in the miri, groups previously failed at least one biologic. 15.6% and 18.3% of the PBO and miri groups respectively failed more than one biologic. Both co-primary endpoints (all p<.000001) and all key secondary endpoints (all p<.000001 except endoscopic remission at W12: p<.001 and W12 clinical remission by CDAI: p=0.001) were achieved. Robust and consistent efficacy at W52 was also demonstrated with similar response rates and treatment effect in patients with and without prior biologic failure (all p<.0001). Conclusion Miri demonstrated statistically significant and clinically meaningful improvements vs PBO in both co-primary composite endpoints and all key secondary endpoints, with an acceptable safety profile.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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 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".