Bowel Urgency in Crohn’s Disease: Effects of Mirikizumab in a Randomized Controlled Phase 3 Study
Bibliographic record
Abstract
BACKGROUND & AIMS: Bowel urgency (BU) is an underrecognized and debilitating symptom of Crohn's disease. Mirikizumab, an interleukin-23p19 inhibitor, is efficacious for BU resolution in ulcerative colitis. We evaluated the efficacy of mirikizumab in achieving early BU response and remission among participants with Crohn's disease enrolled in the phase 3 VIVID-1 study. The associations of disease characteristics with baseline BU and BU resolution were explored. METHODS: Adult participants were randomized to receive mirikizumab or placebo. BU was assessed using the Urgency Numeric Rating Scale (NRS) (range 0-10) at baseline, and every 4 weeks. The proportion of participants with baseline Urgency NRS ≥3 and ≥6 who achieved BU clinically meaningful improvement (CMI) (≥3 change in Urgency NRS) and BU remission (Urgency NRS ≤2) was calculated, and associations of BU CMI and BU remission with clinical outcomes were assessed. RESULTS: At baseline, 94.2% of participants had an Urgency NRS score ≥3. BU positively correlated with the Crohn's Disease Activity Index and abdominal pain. Improvement in BU from baseline was significantly greater in mirikizumab-treated participants as early as week 6 and sustained to week 52 vs patients receiving placebo. Participants treated with mirikizumab achieved significantly higher rates of BU CMI and BU remission at weeks 12 and 52 vs placebo. Mirikizumab-treated participants who achieved BU CMI at week 12 had better clinical and endoscopic outcomes at weeks 12 and 52. CONCLUSIONS: Mirikizumab-treated participants achieved significantly higher rates of BU CMI and remission at weeks 12 and 52, which was associated with better short- and longer-term clinical outcomes. CLINICALTRIALS: gov, Number: NCT03926130.
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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 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".