Mirikizumab effect on bowel urgency resolution in a randomised controlled phase 3 trial of participants with crohn’s disease
Bibliographic record
Abstract
Introduction: Bowel urgency (BU), the sudden or immediate need to have a bowel movement, is an impactful symptom of Crohn’s disease (CD) that varies in intensity. We report the efficacy of the IL-23 p19 inhibitor, mirikizumab (miri) in improving BU among patients with moderately-to-severely active CD from the phase 3 VIVID-1 trial (NCT03926130). VIVID-1 co-primary and gated endpoints, including comparison with ustekinumab, are already reported. Methods: Adult patients (N=1065) were randomised to placebo (PBO) or miri 900mg intravenously at weeks (W) 0, 4, and 8, then 300mg subcutaneously every 4 weeks (Q4W) from W12 to W52. At W12, PBO responders continued PBO to W52, non-responders received the blinded miri regimen per protocol. BU was assessed at W12 and W52 using the Urgency Numeric Rating Scale (UNRS). We evaluated the proportion of patients with baseline (BL) UNRS≥3 and≥6 who achieved BU Clinically Meaningful Improvement (CMI;>3 change in UNRS) and BU remission (UNRS≤2). Treatment comparisons used Cochran-Mantel-Haenszel tests with non-responder imputation for missing values. Results: Study population: 55.1% male. Mean (SD) age 36.2 (13.0) years. Disease duration 7.4 (7.9) years. At BL, median (Q1, Q3) UNRS 6.9 (5.2, 8.1), 94.5% patients achieved UNRS≥3 and 66.0% patients achieved≥6. In patients with BL UNRS≥3, nominally significantly higher proportions of miri versus PBO patients achieved BU CMI and BU remission at both W12 and W52 ([ Table 1 ]). A nominally significantly greater proportion of miri-treated patients achieved W52 BU CMI-composite and BU remission-composite ([ Table 1 ]). Similar results were seen with BL UNRS≥6. Table 1 W12 PBO W12 Miri W12 p-value W12 95% CI W52 PBO W52 Miri W52 p-value W52 95% CI UNRSa CFB (LSM±SE) -1.58 (0.168) -2.44 (0.099) 0.00011 -1.24, -0.48 -1.23 (0.180) -3.24 (0.106) <0.0001 -2.42, -1.60 Patients with BL UNRS≥3 BU CMI-TT 50/186 (26.9) 227/547 (41.5) 0.0004 6.7, 22.0 38/186 (20.4) 301/547 (55.0) <0.0001 28.0, 42.1 BU CMI-compositeb 38/186 (20.4) 251/547 (45.9) <0.0001 18.5, 32.8 BU Remissionc-TT 29/186 (15.6) 134/547 (24.5) 0.01 2.3, 15.0 21/186 (11.3) 209/547 (38.2) <0.0001 21.0, 33.2 BU Remission-composite 21/186 (11.3) 180/547 (32.9) <0.0001 15.7, 27.8 Patients with BL UNRS≥6 BU CMI-TT 38/137 (27.7) 180/376 (47.9) 0.0001 9.8, 28.2 31/137 (22.6) 229/376 (60.9) <0.0001 30.1, 47.3 BU CMI-composite 31/137 (22.6) 188/376 (50.0) <0.0001 18.4, 36.0 BU Remission-TT 11/137 (8.0) 70/376 (18.6) 0.007 3.8, 15.8 13/137 (9.5) 126/376 (33.5) <0.0001 17.1, 31.1 BU Remission-composite 13/137 (9.5) 111/376 (29.5) 0.0002 13.2, 27.0 PBO, N=199; Miri, N=579. Data are N (%) unless otherwise stated. a UNRS scale: 0 (no urgency)-10 (worst possible urgency) 3 . b Composite=Clinical response by PRO (2 of the patient-reported items of the CDAI, AP and SF) at W12 and W52 parameter (CMI or Remission). c BU remission=no to minimal BU (UNRS≤2). Treatment comparison: CFB used a mixed model for repeated measures model containing treatment, BL value, visit, stratification factors and interaction of BL value by visit and treatment by visit. Response rates used Cochran-Mantel-Haenszel tests with non-responder imputation. AP=abdominal pain; BL=baseline; CFB=change from BL; CI=confidence interval; CMI=clinically meaningful improvement; LSM=least squares mean; PBO=placebo; PRO=Patient Reported Outcome; SD=standard deviation; SE=standard error; SF=stool frequency; TT=treat-through; UNRS=Urgency Numeric Rating Scale; W=week. Conclusion: BU is one of the most unrecognised symptoms in patients with CD. Patients enrolled in VIVID-1 had high BU scores at BL. Compared to PBO-treated pts, miri-treated pts achieved nominally significantly higher rates of BU CMI and remission at W12 and W52. Publication History Article published online: 04 September 2025 © 2025. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 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".