Biologic Therapies

Inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC), is caused by long-term inflammation of the digestive tract. While there is no cure for IBD, several types of medicines are used to treat the disease.

The goals of treatment are to reduce inflammation, relieve symptoms, and help people with IBD enter and stay in remission. One type of medicine used to treat moderate to severe IBD is biologic therapy.¹

What are biologic therapies?

Biologic therapies, or biologics, are drugs used to treat IBD. Biologics are made from living cells and are grown in a laboratory.¹

Biologics work in different ways to help to reduce inflammation in the body. They do this by targeting and stopping specific proteins involved in causing inflammation.¹

How does the inflammatory process work?

The inflammatory process is an important part of the body's immune system. When the immune system senses bacteria, viruses, or other infections, it triggers an inflammatory response. This helps the body fight off the infection.²

But people living with IBD have overactive immune systems. They have too much inflammation in their digestive tract. Too much inflammation can damage the digestive tract. This can cause many different symptoms, like cramps, diarrhea, and constipation.³

Biologics work by acting like substances naturally made in the body. They can also block other substances that play a role in inflammation. This helps to relieve IBD symptoms.¹

Examples of biologics used to treat people with IBD

At this time, there are three types of biologic therapies used to treat IBD. These are:¹

• Anti-tumor necrosis factor (anti-TNF) medicines
• Integrin receptor antagonists
• Interleukin-12 (IL-12) and interleukin-23 (IL-23) inhibitors

Biologics can be very effective for people with moderate to severe IBD. They are usually recommended for people who have tried other treatments like anti-inflammatory drugs (aminosalicylates), antibiotics, corticosteroids, or immunomodulators, but:^1,3,4

• The medicines did not work
• The medicines worked at the beginning, but no longer work
• There was a bad reaction to the medicines

Biologic therapy does not work for all people with IBD. However, many patients experience benefits. Some people may notice immediate improvements, but for others it may take up to 8 weeks before symptoms improve. Work with your doctor to make a treatment plan that is right for you.¹

What are anti-TNF medicines?

A protein called tumor necrosis factor alpha (TNF-alpha) is one cause of inflammation in the body. Anti-TNF drugs work by seeking out and blocking the function of these TNF-alpha proteins. This helps stop inflammation.¹

For many people with IBD, anti-TNF drugs can help:¹

• Reduce inflammation
• Relieve symptoms
• Enter and stay in remission
• Heal damage to the walls of the intestines caused by chronic inflammation

Examples of anti-TNF biologics are:¹

• Infliximab (brand name: Remicade®)
• Renflexis®, Inflectra, Avsola (Remicade biosimilars)
• Adalimumab (brand name: Humira®)
• Certolizumab pegol (brand name: Cimzia®)
• Golimumab (brand name: Simponi®)

What are integrin receptor antagonists?

Integrin receptor antagonists are another type of biologic medicine that affects white blood cells. White blood cells are an important part of the body’s inflammatory process.¹

Integrin receptor antagonists target and block a certain protein found on the surface of white blood cells. This prevents the white blood cells from traveling into the body’s tissues from the blood vessels. In this way, these medicines interrupt inflammation.¹

Examples of integrin receptor antagonists are:¹

• Natalizumab (brand name: Tysabri®)
• Vedolizumab (brand name: Entyvio™)

What are interleukin-12 and interleukin-23 inhibitors?

IL-12 and IL-23 are proteins that play a role in inflammation. The biologics that help stop them are called IL-12 and IL-23 inhibitors.¹

Examples of IL-12 and IL-23 inhibitors are:^1,5,6

• Ustekinumab (brand name: Stelara®) – Stelara is approved to treat CD and UC.
• Risankizumab-rzaa (brand name: Skyrizi®) – Skyrizi is an IL-23 inhibitor that was originally approved to treat psoriasis and psoriatic arthritis. As of June 2022, it is approved to treat CD as well.

What are the possible side effects?

Like any medicine, biologic therapy does have the potential for side effects. Side effects can vary depending on the specific drug you are taking. Tell your doctor about any and all medicines or supplements you take. Some drug interactions can have dangerous side effects.^1,5

While serious side effects are rare, people do experience side effects from biologic therapy. These can include:^1,5

• Redness, bruising, or itching at the injection site. This is common and should go away within a day or so.
• Skin reactions. These typically involve a rash or psoriasis-like symptoms.
• Infections. Because biologics affect your immune response, they can make you more likely to get infections. Be sure you are up to date on all vaccines. And tell your doctor if you develop a fever, cough, or flu-like symptoms.
• Severe allergic reactions. If you develop hives or an intense rash after getting a shot or infusion, tell your doctor.

Sometimes, biologics cause immunogenicity. This is when the drug causes the immune system to trigger an unwanted response to the drug. This can cause the drug to not work. Doctors do not know the exact cause of this response, and it does not happen to everyone who takes a biologic.⁷

These are not all the possible side effects of biologics. Talk with your doctor about what to expect with biologic therapy and what may be right for you. You also should call your doctor if you have any changes that concern you when taking a biologic.^1,5

Other things to know

Biologic therapies are given either as a shot (injection) or through an IV (intravenous infusion). How frequently a person receives each dose depends on the type of biologic therapy. In most cases, people start off receiving a dose every 1 to 2 weeks, which then tapers off to less frequent dosing. Your doctor will decide on a dosing schedule that is right for you.¹

Injections are typically given in the thigh or stomach. A doctor or nurse will give you the injection. Or, after instruction by your doctor, you or a loved one can give the injections at home.¹

IV infusions are generally delivered in an infusion center or a doctor's office. It can take anywhere from 30 minutes to several hours to deliver each dose of the infusion.¹

Some vaccines are not safe to get when taking certain biologic drugs. Talk to your doctor about which vaccines you should get.⁵

Biologic therapies are a key area of focus in IBD research. New types of treatments are being designed and tested. In the future, more types of biologics will likely become available.