Entyvio (Vedolizumab)
Infusion Therapy

Understanding Entyvio (Vedolizumab)

Entyvio (vedolizumab) is a humanized monoclonal antibody biologic therapy specifically designed to treat moderate to severe inflammatory bowel disease (IBD), with particular efficacy in ulcerative colitis (UC) and Crohn's disease (CD). Administered by intravenous infusion, Entyvio represents a significant advancement in targeted intestinal anti-inflammatory therapy, offering a gut-selective mechanism that distinguishes it from other available IBD treatments.

At CarePoint Infusion Center, we provide expert Entyvio infusion therapy for patients throughout Northeast Ohio, including Cleveland, Beachwood, Westlake, Hudson, Akron, and surrounding communities. Our experienced team ensures safe, comfortable administration of this specialized biologic medication in our state-of-the-art infusion facility. For biologics, IV iron, and related GI care in one place, see our gastroenterology infusion therapy overview.

Wondering about prior authorization, step therapy, and benefits? Read our patient guide: How to get Entyvio covered by insurance. For our overall PA process, see prior authorization for infusion therapy.

If you are learning about chronic watery diarrhea and microscopic colitis (a separate condition from UC/CD, diagnosed by biopsy), see our patient guide to microscopic colitis—including how advanced therapies may be discussed with your gastroenterologist.

What Conditions Does Entyvio Treat?

Entyvio is FDA-approved for treating adults with:

Entyvio is typically prescribed when patients have:

• Failed to respond to conventional therapies (corticosteroids, immunomodulators)
• Lost response or become intolerant to TNF-α blockers (like infliximab, adalimumab)
• Moderate to severe disease activity requiring biologic intervention
• Need for a gut-selective treatment option with favorable safety profile

How Entyvio Works: The Gut-Selective Mechanism

Entyvio operates through a highly specific mechanism that targets immune cell trafficking to the intestines. The drug is a recombinant humanized IgG1 monoclonal antibody directed against the α4β7 integrin, a crucial protein found on the surface of certain white blood cells including T lymphocytes, B lymphocytes, and dendritic cells.

The Selective Gut-Homing Process

In inflammatory bowel disease, circulating immune cells abnormally infiltrate the inflamed intestinal tissue, driving chronic inflammation. Here's how Entyvio interrupts this process:

Entyvio Dosing and Administration

Entyvio is administered as a 300 mg fixed dose via intravenous (IV) infusion over approximately 30 minutes. The dosing schedule is divided into two phases: induction and maintenance.

Induction Phase (Weeks 0, 2, and 6)

The induction phase is designed to rapidly achieve therapeutic drug levels and gain control of active disease. This phase consists of three separate 300 mg IV infusions:

• Week 0: Initial dose (first infusion)
• Week 2: Second infusion
• Week 6: Third infusion

Most patients begin seeing clinical improvements during or shortly after the induction phase. In clinical practice, approximately 56% of patients achieve clinical response after just two induction infusions at weeks 0 and 2, with response rates increasing to over 86% after completing all three induction doses.

Maintenance Phase (Every 8 Weeks)

After completing induction therapy, patients who have responded transition to the maintenance phase:

• Standard schedule: 300 mg IV infusion every 8 weeks
• Dose intensification option: Every 4 weeks for patients experiencing loss of response or inadequate disease control

This schedule results in 8 total infusions in the first year (the 3 induction doses plus 5 maintenance doses). In subsequent years, patients receive 6 infusions per year (one every 8 weeks).

What to Expect During Your Infusion

At CarePoint Infusion Center, we ensure your Entyvio infusion experience is comfortable and safe:

Clinical Efficacy: What the Research Shows

The efficacy and safety of Entyvio were established in large, pivotal Phase 3 clinical trials known as the GEMINI program, which included randomized, double-blind, placebo-controlled studies published in The New England Journal of Medicine.

Efficacy in Ulcerative Colitis (GEMINI I Trial)

Induction Phase (Week 6):

• Clinical Response: 47.1% of vedolizumab-treated patients achieved clinical response compared to 25.5% with placebo (a significant 21.6% improvement)
• Clinical Remission: 16.9% achieved remission with IV vedolizumab compared to 5.4% with placebo—essentially three times as many patients
• Mucosal Healing: 40.9% of patients showed visible mucosal improvement compared to 24.8% with placebo

Maintenance Phase (Week 52):

• Clinical Remission: Approximately 41.8% of patients treated with vedolizumab every 8 weeks achieved clinical remission compared to 15.9% with placebo
• Steroid-Free Remission: Nearly one-third (31%) of vedolizumab-treated patients achieved corticosteroid-free clinical remission, enabling many to discontinue steroid therapy
• Endoscopic Improvement: Over half (52%) of vedolizumab-treated patients achieved visible mucosal improvement at week 52

Efficacy in Crohn's Disease (GEMINI II Trial)

Induction Phase (Week 6):

• Clinical Remission: 14.5% of patients in the vedolizumab group achieved clinical remission compared to 6.8% in the placebo group

Maintenance Phase (Week 52):

• Clinical Remission: 39.0% of patients who continued on vedolizumab every 8 weeks were in clinical remission compared to 21.6% on placebo
• Corticosteroid-Free Remission: 31.7% of the vedolizumab group achieved corticosteroid-free remission compared to 15.9% in the placebo group

Side Effects and Safety Information

The most frequently reported adverse events with Entyvio are generally mild to moderate in severity and often resolve without treatment discontinuation.

Common Side Effects (>10% incidence)

Other common adverse events include bronchitis, influenza, sinusitis, cough, rash, pruritus (itching), back pain, pain in extremities, fever, and urinary tract infections.

Serious Adverse Effects and Important Monitoring

Pre-Treatment Screening and Ongoing Monitoring

Before beginning Entyvio, patients require testing for:

• Hepatitis B infection
• Tuberculosis (TB) - may need to be repeated annually
• Other infectious diseases relevant to medical history

While on Entyvio maintenance therapy:

• Blood counts and liver function tests: Performed every 4 months
• TB screening: Annually as recommended
• Vedolizumab drug levels: May be checked if patients experience primary nonresponse or loss of response
• Anti-vedolizumab antibodies: Tested if drug levels are subtherapeutic (approximately 4% of patients develop antibodies over time)

Patient Resources & Financial Support

Biologic therapy can be costly, but support programs are available to help eligible patients access Entyvio. Takeda, the manufacturer, offers dedicated resources for patients starting or continuing treatment.