How Does Entyvio Work for Ulcerative Colitis and Crohn’s Disease?

Medically Reviewed by Andrea Wessell, PharmD, BCPS on May 30, 2024
8 min read

Entyvio is a biologic medicine used to treat moderate to severe ulcerative colitis and Crohn’s disease in people who have failed or cannot tolerate other treatments. Studies have shown that some people who took Entyvio were able to achieve remission (free from noticeable symptoms) as early as 6 weeks after starting treatment. Some people were also able to discontinue oral steroid medicine.

Ulcerative colitis and Crohn’s disease are types of inflammatory bowel disease (IBD) that cause irritation and inflammation in the gastrointestinal tract (GI tract). The immune system attacks the GI tract by sending lymphocytes (a type of white blood cell) to it, causing inflammation. Entyvio blocks the lymphocytes from entering the GI tract, decreasing inflammation and promoting healing. 

The effect of Entyvio on disease remission was studied in people with moderate to severe ulcerative colitis and Crohn’s disease. People in these studies were between the ages of 18 and 80 years old and had failed other treatments. These studies looked at the overall response to treatment, endoscopy findings, and whether people could stop taking oral steroids. 

The average age for people with ulcerative colitis was 40 years, 58% of people were male, and 82% were White. Fifty-four percent of people used oral steroid medicine to help control their disease. 

The average age for people with Crohn’s disease was 38, 47% were male, and 84% were White. Forty-eight percent used oral steroid medicine to help control their disease. 

Ulcerative colitis

More people showed a response to treatment with intravenous (IV) Entyvio versus a placebo (no medicine) for ulcerative colitis. Entyvio decreased inflammation and symptoms, and some people were able to stop taking steroids. Results are provided in the tables below. Your results may be different from those seen in the studies. 

Clinical response to treatment

 6 weeks52 weeks
Placebo26%24%
Entyvio47%57%

Clinical remission

 6 weeks52 weeks
Placebo5%16%
Entyvio17%42%

Rate of mucosal healing

 6 weeks52 weeks
Placebo25%20%
Entyvio41%52%

Steroid-free at 52 weeks

Placebo14%
Entyvio 31%

Another study compared the safety and efficacy of Entyvio taken as a shot under the skin vs. a placebo for ulcerative colitis. After two IV treatments, patients received a shot every 2 weeks. Results were comparable with IV treatment and allowed for a more convenient way for some people to get their medicine. The only new side effects discovered were reactions where people got the shots.

Crohn’s disease

More people achieved remission with IV Entyvio vs. placebo for Crohn’s disease. More people taking Entyvio had improvements in symptoms and were able to stop using steroids. Results are provided in the tables below. Your results may be different from what was seen in the studies. 

Clinical remission

 6 weeks52 weeks
Placebo7%22%
Entyvio15%39%

Clinical response at 52 weeks

Placebo30%
Entyvio44%

Steroid-free at 52 weeks

Placebo16%
Entyvio32%

A study was done to compare the safety and efficacy of Entyvio taken as a shot under the skin for Crohn’s disease to that of a placebo. Results were similar to those of the IV treatment, with more people on Entyvio achieving remission and more people being steroid-free, compared to a placebo. 

For both ulcerative colitis and Crohn’s disease, you may start to see improvement in symptoms within 6 weeks. Some patients can achieve remission as early as 6 weeks, but most require longer treatment to achieve full effects. You may see fewer bowel movements, less stomach pain, and less bleeding as early as 2 weeks after starting treatment. If you do not feel a benefit by week 14, your health care provider may recommend a different treatment. 

The most common side effects are the common cold, headache, joint pain, fever, and nausea. 

You may be more likely to get infections, like the common cold, during treatment. Be sure you are up to date on vaccinations before starting Entyvio. Also, be sure you are getting enough sleep, eating a balanced diet, and washing your hands often. Notify your health care provider if you have signs of an infection. 

To limit headaches, be sure you are getting enough sleep, staying hydrated, exercising, and not skipping meals. Hot or cold compresses, meditation, resting in a cool, dark room, and massage may also help.

If you have joint pain or a fever, your health care provider may recommend an over-the-counter (OTC) medication such as acetaminophen. 

If you have nausea, try eating smaller, more frequent meals. Avoid spicy foods, fried foods, and alcohol, as they can make nausea worse. Try eating bland foods like toast, rice, bananas, and applesauce. If your nausea is bothersome or severe, talk with your health care provider. They may recommend an OTC or prescription medication. 

The Entyvio Pen can cause reactions where you get the shot. These reactions are usually mild and include rash, swelling, redness, itching, and warmth. During the studies, these reactions improved with each injection and did not lead to people needing to stop the drug. If you have a reaction, apply a warm or cool compress to the area for 15 to 20 minutes. Your health care provider may recommend an over-the-counter (OTC) pain reliever, such as ibuprofen, or an OTC antihistamine, like diphenhydramine, for itching. 

These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

Entyvio comes as an IV infusion and a self-administered injectable pen or prefilled syringe. It will first be given as an IV by your health care provider at a hospital, doctor’s office, or clinic. Entyvio can cause IV-related reactions and allergic reactions, so your health care provider will monitor you for side effects during the first doses. Tell your health care provider right away if you have a rash; itching; swelling of the lips, tongue, throat, or face; shortness of breath; trouble breathing; wheezing; dizziness; a hot feeling; or a feeling of skipped heartbeats. 

The IV treatment requires a first dose, a dose 2 weeks later, another dose 4 weeks later, and then every 8 weeks. An IV will be placed in your arm and will take about 30 minutes to complete. 

If you choose to self-administer the pen or syringe, you will need a first IV dose and then one 2 weeks later. Four weeks after that, you will have shots under your skin every 2 weeks. The pen and syringe should be stored in the refrigerator. It should be taken out of the refrigerator at least 30 minutes before you plan to inject it. It can be left out of the refrigerator for up to 7 days. After 7 days, the medicine is no longer usable. The pen and syringe can be used to inject the drug into the thigh, belly area, or upper arms. Only health care providers or caregivers should give the shot in the upper arm area. You should not inject into moles, scars, bruises, or irritated areas. Rotate Injection sites with each shot. 

How to use the Entyvio Pen

  1. Take it out of the refrigerator and leave it at room temperature for at least 30 minutes.
  2. Wash your hands.
  3. Inspect the pen. It should be clear to slightly yellow in color and free from floating particles.
  4. Clean the injection site with alcohol and let your skin dry.
  5. Remove the purple cap from the pen.
  6. Place the pen on the injection site at a 90-degree angle and push down.
  7. Hold it down for at least 10 seconds. You may hear two clicks; keep holding. Once the medicine window is purple, you may lift the pen.
  8. Safely throw the pen away in a sharps container.
  9. Report any issues to your health care provider.

How to use the subcutaneous prefilled syringe

  1. Take it out of the refrigerator and leave it at room temperature for at least 30 minutes.
  2. Wash your hands.
  3. Inspect the syringe. It should be clear to slightly yellow in color and free from floating particles.
  4. Clean the injection site with alcohol and let your skin dry.
  5. Remove the needle cap by pulling it straight off. Throw the cap away.
  6. Pinch the skin and keep holding it until the shot is complete.
  7. Insert the syringe at a 45-degree angle.
  8. Push down on the plunger until all of the medicine is injected. 
  9. While keeping pressure on the plunger, pull the needle out of the skin.
  10. Release the plunger, which will activate the needle cover.
  11. Safely throw the syringe away in a sharps container.
  12. Report any issues to your health care provider.

Entyvio can increase your risk of getting an infection, so you should avoid other medications that increase this risk. These include immunosuppressants such as natalizumab and TNF blockers. 

You should also avoid live vaccines such as yellow fever; measles, mumps, and rubella (MMR); and FluMist. Before starting treatment, your health care provider should make sure you are up to date on all vaccines. 

Chronic inflammation, seen in ulcerative colitis and Crohn’s disease, can suppress a group of enzymes called CYP450. Some medicines are metabolized by these enzymes. If you take a CYP450 substrate medicine, your dosage may need to be adjusted when starting or stopping Entyvio. Ask your pharmacist or other health care provider if any of your medicines are CYP3A4 substrates. 

This is not a complete list of interactions. Tell your pharmacist or other health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them find out if there are any interactions, or if you need a dose adjustment.

Entyvio requires a prescription from a health care provider. A specialty pharmacy will coordinate the delivery of your medicine. 

A copay assistance program from the drugmaker may allow you to pay as little as $5 per dose. Eligibility depends on your current prescription insurance coverage.

Those with government insurance and those without insurance can call EntyvioConnect at 844-ENTYVIO (844-368-9846) to review your options.