ENTYVIO for UC

Results for Patients with Ulcerative Colitis

ENTYVIO helps control gastrointestinal (GI) inflammation that occurs in adults with moderately to severely active ulcerative colitis when certain other medicines have not worked well enough or cannot be tolerated.

In clinical studies, ENTYVIO was shown to help many patients achieve results.

Early Results

6 weeks

Early Results

  • At Week 6, 47% of patients on ENTYVIO achieved clinical response compared to 26% on placebo.

Long-Term Remission

42% of Patients Achieved Remission

Long-Term Remission

  • At 1 year, 42% of patients achieved remission compared to 16% of patients on placebo.

Some patients with ulcerative colitis experienced improvement in how their intestinal lining looked to their doctor.

  • As early as Week 6, 41% of patients experienced improvement in how their intestinal lining looked to their doctor*
  • At 1 year, 52% of patients experienced improvement in how their intestinal lining looked to their doctor

    *Compared to 25% of patients on placebo at 6 weeks.

    Compared to 20% of patients on placebo at 1 year.

Individual results may vary.

In a separate head-to-head study, at one year, ENTYVIO helped significantly more moderate to severe ulcerative colitis patients than HUMIRA®‡ (adalimumab) to achieve remission.

Superior
  • At 1 year, 31.3% of ENTYVIO patients achieved remission compared to 22.5% of HUMIRA patients in a clinical study.

    HUMIRA® AbbVie, Inc. North Chicago, IL.

    For more information related to adalimumab, please see www.abbvie.com.

Individual results may vary.

Important Safety Information about ENTYVIO® (vedolizumab)

  • Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients.
  • ENTYVIO may cause serious side effects, including:
    • Infusion-related and serious allergic reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get immediate medical help if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing).
    • ENTYVIO may increase your risk of getting a serious infection. Before receiving and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or symptoms of an infection, such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination.
    • People with weakened immune systems can get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). Although unlikely while receiving ENTYVIO, a risk of PML cannot be ruled out. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision.
    • Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your abdomen, dark urine, or yellowing of the skin and eyes (jaundice).
  • The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO. Call your healthcare provider for medical advice about side effects.
  • Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have or think you may have an infection or have infections that keep coming back; have liver problems; have tuberculosis (TB) or have been in close contact with someone with TB; have recently received or are scheduled to receive a vaccine; or if you are pregnant, breastfeeding, plan to become pregnant, or plan to breastfeed.

Please see the full Prescribing Information, including the Medication Guide, for ENTYVIO and talk with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Uses of ENTYVIO® (vedolizumab)

ENTYVIO is a prescription medicine used in adults for the treatment of:

  • moderately to severely active ulcerative colitis
  • moderately to severely active Crohn’s disease

Important Safety Information about ENTYVIO® (vedolizumab)

Please see the full Prescribing Information, including the Medication Guide, for ENTYVIO and talk with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Uses of ENTYVIO® (vedolizumab)

ENTYVIO is a prescription medicine used in adults for the treatment of: