📈 New decision support for vedolizumab in UC: Real-world validation
🔥 Main in 3 points
- A clinical decision support tool (CDST) reliably stratifies UC patients by chance of vedolizumab response.
- In a Dutch real-world cohort, high-probability UC patients had markedly better clinical, biochemical, and steroid-free remission at week 54 (e.g., clinical remission: 81.8% vs 33.3%, p = 0.003).
- No predictive value of the CDST was found in Crohn's disease patients.
🧪 Context
Retrospective cohort (n = 41 UC, 32 CD) using validated CDST, compared vedolizumab responses in groups predicted to have high vs low/intermediate response probability.
📍 Practical significance
- For UC: Use CDST tools to guide patient selection for vedolizumab—high-score patients much more likely to achieve remission.
- For CD: Current scoring systems may not inform vedolizumab outcomes—clinical judgement prevails.
- Consider implementing validated prediction tools at point-of-care in UC for optimising therapy and resource allocation.
🔗 Source — PubMed | DOI
🔄 Vedolizumab is increasingly used post-liver transplant for UC—safety reassuring
🧾 For patients with UC after liver transplantation
- Most maintain clinical remission long-term post-LT (81.2%), similar to pre-LT levels.
- Moderate-to-severe endoscopic inflammation persists in ~28% despite stable symptoms.
- Use of advanced therapies—especially vedolizumab—increased significantly after LT (12.7% vs 3.7%, p = 0.005), with no uptick in infection risk.
⚠️ With caution
- Endoscopic surveillance remains crucial: symptoms may not reflect mucosal disease.
- Interdisciplinary collaboration is needed for therapy individualisation.
📍 What to do
- Don’t hesitate to use vedolizumab post-LT if needed; monitor for persistent endoscopic activity.
- Infection risk does not appear to rise with advanced therapy in this setting.
🔗 Source — PubMed | DOI
🛡️ Pharmacovigilance update: Gastrointestinal AEs with vedolizumab—FAERS decade review
🔥 Main in 3 points
- 10 years of FAERS data: 17,943 GI adverse event (AE) reports linked to vedolizumab, 95 event types exceeded signal threshold.
- 74% of signalled GI events are not detailed on current product labelling (notably, diarrhea, abdominal pain, haematochezia, frequent bowel movements).
- Serious GI AEs are more common in males and patients <50 kg; median onset: ~190 days.
🧪 Context
Retrospective review, 59,976 cases in the US FAERS 2014–2024, disproportionality analysis.
📍 Actions
- Stay vigilant for unlabelled GI AEs, especially early after initiation and in at-risk groups (men, lower body weight).
- Encourage AE reporting; integrate signal awareness into patient monitoring.
🔗 Source — PubMed | DOI
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