Entyvio (Vedolizumab)
Gut selective integrin antibody for ulcerative colitis and Crohn's disease
Entyvio is the brand name of the humanised monoclonal antibody vedolizumab developed by Takeda. The European Medicines Agency granted marketing authorisation in 2014 for the treatment of adult patients with moderately to severely active ulcerative colitis or moderately to severely active Crohn's disease who had responded inadequately to conventional therapies or to a TNF α inhibitor. Vedolizumab has been established for years as an intravenous infusion, and since 2020 a subcutaneous pre filled syringe is also available for maintenance therapy.
The distinctive feature of vedolizumab is its gut selective action. Unlike TNF α antibodies, which modulate the systemic immune response broadly, vedolizumab specifically interferes with lymphocyte migration into the bowel wall. The risk of infection outside the gastrointestinal tract is therefore comparatively low, which makes vedolizumab a preferred option for patients with comorbidities or a history of severe infections.
Mechanism of Action
Vedolizumab is an IgG1 antibody that binds highly selectively to the α4β7 integrin on the surface of T lymphocytes. Integrins are adhesion molecules that regulate the homing of immune cells. α4β7 binds to the addressin MAdCAM-1 (mucosal addressin cell adhesion molecule 1), which is expressed on the endothelial cells of intestinal vessels. This interaction directs activated lymphocytes into the intestinal mucosa.
By binding α4β7, vedolizumab blocks the interaction with MAdCAM-1. Lymphocytes can no longer migrate from the bloodstream into inflamed gut tissue. The local inflammatory response wanes and the mucosa can heal. Because MAdCAM-1 is expressed almost exclusively in the gut, the effect is confined to this region. Immune function in the lung, skin and central nervous system is not meaningfully affected.
This selectivity is a decisive safety advantage. With other integrin antibodies such as natalizumab, which block both α4β1 and α4β7, there is a risk of progressive multifocal leukoencephalopathy (PML) caused by the JC virus. For vedolizumab this risk was not confirmed in phase III studies or in extensive post marketing surveillance.
Indications
- Ulcerative colitis: moderately to severely active disease in adults with inadequate response, loss of response or intolerance to conventional therapy or TNF α inhibitors
- Crohn's disease: moderately to severely active disease in adults with analogous treatment failure
- Pouchitis: chronic inflammation of the ileal pouch after colectomy in ulcerative colitis, authorisation extended in 2024
- Refractory inflammatory bowel disease: an option for patients in whom previous biologics have failed or whose infection risk limits other therapies
Dosage and Administration
Intravenous induction: 300 mg as an infusion over 30 minutes at weeks 0, 2 and 6. Intravenous maintenance: 300 mg every 8 weeks, with interval shortening to every 4 weeks possible if efficacy wanes. Subcutaneous maintenance: 108 mg every 2 weeks after completed intravenous induction (no earlier than week 6).
The infusion is administered in a specialised unit, with monitoring for at least one hour after dosing. Premedication with antihistamines or corticosteroids is not routinely recommended. Renal impairment: no dose adjustment required. Hepatic impairment: no dose adjustment required; data in severe impairment are lacking. Older patients: no dose adjustment, clinical experience over age 75 is limited.
Response is evaluated at week 10. Patients without therapeutic response by week 14 should stop treatment. When there is a response, therapy is typically continued for a year or longer, with the duration guided by remission stability and mucosal healing.
Side Effects
Very common (over 10 percent): nasopharyngitis, headache, arthralgia.
Common (1 to 10 percent): upper respiratory tract infections, sinusitis, bronchitis, gastroenteritis, fatigue, fever, rash, pruritus, back pain, myalgia, hypertension, infusion associated reactions (flushing, chills, nausea).
Uncommon: local reactions at the subcutaneous injection site (redness, pain, itching), anal fissures, pneumonia, herpes zoster, oral candidiasis.
Rare and important: severe hypersensitivity reactions including anaphylaxis, elevated liver transaminases, opportunistic infections. Progressive multifocal leukoencephalopathy (PML) was not observed under vedolizumab in registration trials; a theoretical residual risk cannot be fully excluded, so any unexplained neurological symptom must be evaluated urgently.
Interactions
- Live vaccines (MMR, varicella, yellow fever, BCG, oral polio): avoid during and for up to 3 months after therapy, optimise vaccination status before starting treatment
- TNF α inhibitors (infliximab, adalimumab): do not use concomitantly, higher infection risk without a clear additional benefit
- Natalizumab: avoid combination, additive integrin blockade potentially hazardous
- Corticosteroids, thiopurines (azathioprine, 6 mercaptopurine), methotrexate: clinically common combinations, infection risk moderately increased
- Inactivated vaccines (influenza, pneumococcal, COVID-19): can be given during vedolizumab therapy, immune response partly attenuated
Special Notes
Screening before start: tuberculosis test, hepatitis B and C serology, review of vaccination status. Active severe infection: contraindication; start therapy only after resolution.
Pregnancy: data are limited, but the Takeda PIANO registry in patients with inflammatory bowel disease showed no increase in malformations. Continuation during stable remission is considered acceptable in current ECCO guidelines, with individual gastroenterological and gynaecological assessment. Breastfeeding: small amounts pass into breast milk, current recommendations consider breastfeeding during therapy possible.
Monitoring: clinical response, stool frequency, rectal bleeding, faecal calprotectin, endoscopy and mucosal histology for mucosal healing. In loss of efficacy, check antibody titre and trough levels; interval shortening is possible. Regular routine laboratory tests (blood count, liver values, inflammatory markers).
You might also be interested in
- Infliximab, TNF α antibody as an alternative in inflammatory bowel disease
- Ustekinumab, IL-12/23 antibody as reserve therapy
- Mesalazine, basic therapy for mild ulcerative colitis
- Methotrexate, immunosuppressant in Crohn's disease
- Azathioprine, thiopurine for remission maintenance
Frequently Asked Questions
How long does it take for Entyvio to work?
The onset of action is comparatively slow. Many patients notice improvement between week 6 and week 10, and full remission may take further months. Those who show no response at all by week 14 should not continue treatment.
Is vedolizumab safer than TNF blockers?
Because of its gut selectivity, systemic infections are less frequent under vedolizumab than under TNF α inhibitors. This applies in particular to respiratory infections, tuberculosis reactivation and opportunistic infections. In older patients and in those with a high baseline infection risk this is a frequent argument for using vedolizumab first.
Can I switch from infusion to pre filled syringe?
Yes. After completed intravenous induction (at least two infusions) you can switch to subcutaneous maintenance therapy with 108 mg every two weeks. After training, the pre filled syringe or the autoinjector is used at home, which reduces hospital visits.
Can I be vaccinated while on Entyvio?
Inactivated vaccines such as the seasonal flu shot, pneumococcal and COVID-19 vaccines are possible during therapy and expressly recommended, although the immune response may be partially reduced. Live vaccines (MMR, varicella, yellow fever) must not be given during ongoing therapy; they should be updated before treatment starts whenever possible.
Sources
- EMA, Entyvio (Vedolizumab) EPAR
- ECCO, European Crohn's and Colitis Organisation Guidelines
- AWMF, S3 Guidelines on Ulcerative Colitis and Crohn's Disease
- Gelbe Liste, Vedolizumab active substance profile
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