What is Entyvio (Vedolizumab)?
Entyvio (vedolizumab) is an integrin receptor antagonist—specifically a humanized monoclonal antibody targeting α4β7 integrin—FDA-approved for treating adults with moderately to severely active ulcerative colitis and Crohn's disease. 1
Mechanism of Action
- Vedolizumab selectively blocks α4β7 integrin receptors, which prevents gut lymphocyte trafficking and provides gut-specific anti-inflammatory effects 2, 3
- This gut-selective mechanism distinguishes it from less selective integrin antagonists (like natalizumab), making it unlikely to cause progressive multifocal leukoencephalopathy (PML), a serious brain infection risk seen with broader integrin blockade 2, 3
FDA-Approved Indications
Entyvio is indicated for adults with:
The medication is approved for patients who have had inadequate response, loss of response, or intolerance to conventional therapies including corticosteroids, immunomodulators, or TNF-α inhibitors 3, 4
Clinical Positioning in Treatment Algorithms
For Ulcerative Colitis (Biologic-Naive Patients):
- The AGA suggests using infliximab or vedolizumab rather than adalimumab for induction of remission in moderate-to-severe ulcerative colitis 5
- Vedolizumab demonstrated superior clinical remission rates compared to adalimumab (34.2% vs. 24.3%) in the head-to-head VARSITY trial 5
- All biologics (infliximab, adalimumab, golimumab, vedolizumab, tofacitinib, ustekinumab) are superior to placebo for both induction and maintenance of remission, with vedolizumab showing a relative risk of 2.22 for induction and 2.31 for maintenance 5
For Ulcerative Colitis (TNF-Antagonist Exposed Patients):
- In patients previously exposed to infliximab (especially primary non-responders), the AGA suggests using ustekinumab or tofacitinib rather than vedolizumab or adalimumab 5
- However, patients prioritizing safety over maximal efficacy may reasonably choose vedolizumab as an alternative 5
For Crohn's Disease:
- Vedolizumab is effective for moderate-to-severe Crohn's disease, though clinical trial results showed mixed outcomes at early timepoints 2, 6
- The GEMINI II trial demonstrated significant efficacy at 52 weeks for both clinical remission and CDAI-100 response in maintenance therapy 2
Administration and Dosing
Intravenous formulation:
- 300 mg administered via IV infusion over approximately 30 minutes 1, 3
- Dosing schedule: at weeks 0,2, and 6, then every 8 weeks thereafter 3
Subcutaneous formulation:
- Available as single-dose prefilled syringe or prefilled pen (ENTYVIO PEN) 1
- Administered every 2 weeks after at least 2 IV infusions 1
- Can be self-administered at home after proper training 1
Safety Profile
Common adverse effects include: 3
- Nasopharyngitis, headache, arthralgia, nausea, pyrexia
- Upper respiratory tract infection, fatigue, cough, bronchitis
- Back pain, rash, pruritus, sinusitis
Serious potential risks: 1
- Infusion-related and allergic reactions (rash, itching, swelling, shortness of breath, wheezing, dizziness) 1
- Infections due to immune system effects 1
- Liver injury with elevated transaminases and/or bilirubin 1
- PML risk cannot be entirely ruled out, though no cases have been reported to date and the gut-selective mechanism makes this unlikely 2, 3
Key Clinical Considerations
- Vedolizumab is generally well-tolerated with low rates of serious adverse events comparable to placebo in clinical trials 5
- The gut-selective mechanism provides a favorable safety profile compared to systemic immunosuppression 2
- Combination therapy with thiopurines or methotrexate may enhance efficacy, though this applies more broadly to TNF antagonists 7
- Patients should be monitored during and after IV infusions for allergic reactions 1
- Screen for active infections before initiating therapy and monitor for new infections during treatment 1