Treatment of Moderate to Severe Crohn's Disease

Introduction to Vedolizumab

The European Crohn's and Colitis Organisation (ECCO) strongly recommends vedolizumab for induction of response and remission in patients with moderate-to-severe Crohn's disease with inadequate response to conventional therapy and/or to anti-TNF therapy (strong recommendation, moderate-quality evidence) 1
ECCO also strongly recommends vedolizumab for maintaining clinical remission in patients with moderate-to-severe Crohn's disease who achieved remission with vedolizumab 1
The American Gastroenterological Association strongly recommends vedolizumab for induction and maintenance therapy in moderate-to-severe Crohn's disease, with a strong recommendation and moderate-quality evidence 2

Vedolizumab is specifically recommended for patients who have previously failed anti-TNF therapy 1
The European Society of Gastrointestinal Endoscopy supports the use of vedolizumab as a gut-selective α4β7 integrin antagonist that limits systemic immunosuppression, particularly important in elderly patients with comorbidities 3

Clinical trials demonstrated that vedolizumab was superior to placebo in achieving clinical remission (RR: 2.01; 95% CI: 1.50–2.71) and clinical response (40.8% vs 25.7%) 1
Clinical remission rates at week 52 were 46.9% for vedolizumab versus 19.0% for placebo in clinical trials, indicating effective control of symptoms 3
Maintenance therapy with vedolizumab every 8 weeks resulted in clinical remission at week 52 1

The proposed regimen for vedolizumab is induction with 300mg IV at weeks 0, 2, and 6, and maintenance with 300mg IV every 8 weeks thereafter, consistent with FDA-approved guidelines and standard dosing recommendations from ECCO and the American College of Gastroenterology 1, 2, 4

Vedolizumab has a favorable safety profile with no increased risk of serious adverse events compared to placebo 1
Vedolizumab has a favorable safety profile in elderly patients with comorbidities, such as hypertension, diabetes, and dementia, due to its gut-selective mechanism of action 3
Long-term safety data show no new or unexpected safety concerns 4

Assess response between weeks 8-14 before first maintenance dose, and continue maintenance dosing every 8 weeks if response is adequate 1, 4
Monitor for clinical improvement in symptoms, including reduction in perianal discomfort and drainage, improvement in stool frequency and consistency, resolution of rectal bleeding, and normalization of inflammatory markers (calprotectin) 1
If inadequate response is observed, treatment modification, such as dose escalation to every 4 weeks, may be considered, with approximately 50% of patients recapturing clinical response 4