OP05 Primary efficacy and safety of mirikizumab in moderate to severe Crohn’s Disease: results of the treat-through VIVID 1 study
Bibliographic record
Abstract
Abstract Background Mirikizumab (miri) is a selective IL23p19 monoclonal antibody approved for the treatment of ulcerative colitis. The primary focus of the VIVID-1 trial (NCT03926130) was to demonstrate the efficacy and safety of mirikizumab (miri) compared to placebo (PBO) in patients (pts) with moderate-to-severe Crohn’s disease. Here we present primary efficacy and safety of miri compared to placebo (PBO) up to Week 52 (W52) 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 6:3:2 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. At W12, PBO responders continued PBO to W52; PBO non-responders received the same blinded miri regimen (IV then SC) as described above. The co-primary endpoints assessing superiority of miri over PBO were composite endpoints: 1) PRO clinical response at W12 and endoscopic response at W52, and 2) PRO clinical response at W12 and clinical remission by Crohn’s Disease Activity Index (CDAI) at W52. The adjusted risk differences were calculated, and the comparison was performed by CMH test. Nonresponder imputation was used. Results Baseline characteristics were similar across treatment groups. 48.7% of pts in the PBO, and 48.5% in the miri, group 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 (Figure 1A, 1C, all p<.000001) and all key secondary endpoints (Figure 1E, 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 (Figure 1B, 1D, all p<.0001). Overall safety was consistent with the known safety profile of miri (Table 1). Conclusion In this phase 3 CD study, 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.
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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 | 0.002 | 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 | 0.001 | 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".