Trial reportJournal of Crohn's & colitis2025
Impact of mirikizumab treatment on fatigue in patients with moderately to severely active Crohn's disease: results from the phase 3 VIVID-1 study.
Trial report in Journal of Crohn's & colitis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03926130 (A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The impact of ustekinumab and tumor necrosis factor antagonists on extraintestinal manifestations of Crohn's disease: a systematic review and meta-analysis.Frontiers in pharmacology · 2026Pooled it
- Is There a Way to Break the Glass Ceiling in the Diagnosis and Treatment of Extraintestinal Manifestations (EIMs) in the Course of Inflammatory Bowel Diseases? A Comprehensive Review of Diagnosis, Pathophysiology, and Treatment of EIM.Journal of clinical medicine · 2026Review
- Fatigue in inflammatory bowel disease: Mechanisms, assessment, and management strategies.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundFatigue is a debilitating multifactorial symptom experienced by patients with Crohn's disease (CD). Mirikizumab, an anti-interleukin-23p19 antibody, demonstrated significant efficacy and safety in the patients with moderately to severely active CD. This analysis investigated the impact of mirikizumab on fatigue and the association between changes in clinical, endoscopic, and patient-reported outcomes with improvement in fatigue from baseline in the Phase 3 VIVID-1 study.
methodsAdult patients with moderately to severely active CD that failed at least 1 biologic agent or conventional therapy were randomized to receive mirikizumab or placebo. Fatigue was assessed via the validated Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire. Fatigue associations with patient-reported outcomes, endoscopic, and clinical measures were assessed via Pearson correlation analysis.
resultsAt Week 12, 43% and 33%, and at Week 52, 46% and 36% of mirikizumab-treated patients achieved ≥ 6 and ≥ 9 fatigue score improvements vs placebo (Week 12, 31%, 22%; Week 52, 20%, 16%), respectively. Baseline fatigue scores were strongly associated with depressive symptoms and moderately associated with quality of life (QoL) at baseline. Improvements in fatigue at Weeks 12 and 52 were strongly associated with QoL and patient-reported outcomes and weakly with objective markers of inflammation and disease activity.
conclusionsMirikizumab-treated patients with CD achieved higher rates of clinically meaningful improvement in fatigue vs placebo at Weeks 12 and 52, which correlated with improvement in clinical and patient-reported outcomes. Baseline fatigue severity was strongly associated with depressive symptoms in VIVID-1 (NCT03926130).
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Registered trials
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