Biologics 2 – Entyvio/Stelara – Dr Paul Froomes – Consultant Gastroenterologist

Entyvio (Vedolizumab) Stelara (Ustekinumab)

for Ulcerative Colitis or Crohn's disease

STELARA® is a prescription medicine used to treat adults 18 years and older with moderately to severely active Crohn’s disease who have already taken other medicine that did not work well enough or they could not tolerate it. There are many different naturally occurring molecules in the body that contribute to inflammation. Patients with Crohn’s disease are found to have elevated levels of two of these molecules, IL-12 and IL-23. STELARA® works differently and is the only FDA-approved medicine that targets IL-12 and IL-23, which are thought to be associated with gastrointestinal inflammation in Crohn’s disease.

STELARA® is the only Crohn’s disease treatment that starts with a one-time IV infusion, followed by maintenance injections given under the skin every 8 weeks.

Over the last seven years, more than 180,000 patients have been prescribed STELARA® for the treatment of other autoimmune conditions. It has also been approved by the FDA for the treatment of adult patients with moderately to severely active Crohn’s disease. Clinical studies included patients who were new to, had experience with, or did not respond to biologics.* Of the patients who were new to, or had experience with biologics, the majority found relief from their Crohn’s disease symptoms in just six weeks after the one-time intravenous (IV) infusion of STELARA®, with noticeable improvement as early as three weeks.

Additionally, the majority of those continuing treatment with STELARA® subcutaneous maintenance doses were in remission through the end of the one-year study.

Risks of Stelara

STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

• Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment with STELARA®.

• If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA®.

You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay. Before starting STELARA®, tell your doctor if you:

• think you have an infection or have symptoms of an infection such as: fever, sweats, or chills. muscle aches, cough, shortness of breath, blood in phlegm, weight loss

• are being treated for an infection

• get a lot of infections or have infections that keep coming back

• have TB, or have been in close contact with someone with TB

After starting STELARA®, call your doctor right away if you have any symptoms of an infection (see above).

Cancers

STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your doctor if you have any new skin growths.

Reversible posterior leukoencephalopathy syndrome (RPLS) RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.

Serious Allergic Reactions

Serious allergic reactions can occur. Stop using STELARA® and get medical help right away if you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.

Lung Inflammation

Cases of lung inflammation have happened in some people who receive STELARA® and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with STELARA®.

ENTYVIO is a prescription medicine used in adults with moderate to severe ulcerative colitis (UC) or Crohn’s disease (CD). If you have moderate to severe UC or CD, and one or more of the following is true, talk to your healthcare provider and ask if ENTYVIO may be right for you.

How ENTYVIO Works

Normal Immune Response – As part of your natural immune response, white blood cells are programmed to travel to different body tissues, defending against disease.

GI-Directed White Blood Cells – There are certain white blood cells that are directed to enter the GI tract. In people with ulcerative colitis (UC) and Crohn’s disease (CD), the increased number of these cells causes inflammation and certain symptoms.

ENTYVIO’s Focus – ENTYVIO works to block the movement of these gut‑directed white blood cells into the GI tract. This helps to control inflammation and symptoms of UC and CD.

ENTYVIO is a prescription medicine used in adults:

with moderate to severe ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, induce and maintain remission, reduce or stop the use of corticosteroids, and improve the way the lining of your large intestine looks to your healthcare provider.
with moderate to severe Crohn’s disease (CD) when certain other CD medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, achieve remission, and reduce or stop the use of corticosteroids.

ULCERATIVE COLITIS – ENTYVIO treats gastrointestinal (GI) inflammation that occurs in adults with moderately to severely active UC. If you have not experienced the results you’re looking for from other treatments, including steroids, immunosuppressants, or biologic therapies, or if certain medications cannot be tolerated, talk to your doctor and ask if ENTYVIO may be able to help.

In as early as 6 weeks, 47% of patients with UC achieved response*

At 1 year, 42% of patients with UC achieved remission^†

2x as many patients with UC taking ENTYVIO were likely to achieve steroid-free remission at 1 year versus those who took a placebo

*Compared to 26% of patients with UC in response on placebo at 6 weeks

^†Compared to 16% of patients with UC in remission on placebo at 1 year

Individual results may vary.

Improvement beyond remission – In addition to early response and long-term remission at one year, some patients experienced improvement in how their intestinal lining looked to their doctor indicating that their disease was less active.

In as early as 6 weeks, 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

CROHNS DISEASE – ENTYVIO treats gastrointestinal (GI) inflammation that occurs in adults with moderately to severely active CD. It works by focusing at the site of inflammation in the GI tract. If you have not experienced the results you’re looking for from other treatments, including steroids, immunosuppressants, or biologic therapies, or if certain medications cannot be tolerated, talk to your doctor and ask if ENTYVIO may be able to help.

In as early as 6 weeks, 15% of patients with CD achieved remission*

At one year, 39% of patients with CD achieved remission^†

*Compared to 7% of patients with CD in remission on placebo at 6 weeks

^†Compared to 22% of patients with CD in remission on placebo at 1 year

Individual results may vary.

ENTYVIO provided remission without depending on steroids:

2x as many patients with CD taking ENTYVIO achieved steroid-free remission compared to patients on placebo at 1 year.

Precautions

ENTYVIO may cause serious side effects, including:
- Infusion 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.
- It may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). People with weakened immune systems can get PML, which 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.