Biologic Therapies

Inflammatory bowel disease (IBD) is caused by long-term inflammation of the digestive tract. IBD includes both Crohn’s disease and ulcerative colitis.¹

There is no cure for IBD. But it can be managed. Biological therapies are one type of drug management for IBD. The goal of treating a person with IBD with biologics is to reduce inflammation. This helps:²

• Reduce symptoms
• Reach remission
• Stay in remission

Biologics may be used to treat moderate or severe IBD. Biologics are drugs made from living cells. These cells can come from parts of the blood, proteins, viruses, or tissue. The process of making biologics turns products made from cells into drugs that can prevent, treat, and cure disease. These are different from most traditional drugs. Traditional drugs are made from chemicals in a lab. Their ingredients are not directly derived from living cells.^2,3

How do biologics work for IBD?

It is the immune system’s job to produce inflammation. This helps healthy people fight off disease-causing microbes. When the immune system senses bacteria, viruses, or parasites, it releases inflammatory cells. These cells target and destroy the invading microbes.⁴

But sometimes the immune system is triggered too easily. The inflammatory cells then mistakenly attack healthy tissues. This causes chronic, or long-term, inflammation. Chronic inflammation of digestive tissues is a hallmark of IBD.^4,5

Biologics modify the immune system by lessening its activity. In IBD, this is key to reducing its attacks on healthy tissues.⁶

Examples of biologics for IBD

There are a number of different biologics approved by the US Food and Drug Administration (FDA) to treat IBD. They fall into 3 main categories:²

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

These categories are based on what the biologics target in the immune system’s inflammatory process.

Anti-TNF agents

Anti-TNF agents work against small proteins that promote inflammation in the intestine. They do this by binding to these proteins or blocking them. Anti-TNF agents help reduce inflammation in digestive tissues.²

Anti-TNF agents also help promote healing of tissues in the gut. But this takes time. It can take 8 weeks for people taking an anti-TNF for IBD to feel relief. But for some people, symptoms are relieved faster.²

Anti-TNF agents do not work for everyone with IBD.²

Examples of anti-TNF biologics include:²

• Cimzia^® (certolizumab pegol) – for moderate to severe Crohn's disease
• Humira^® (adalimumab) – For moderate to severe Crohn's disease and UC
• Remicade^® (infliximab) – For moderate to severe Crohn's disease and UC
• Simponi^® (golimumab) – for moderate to severe UC

Integrin receptor antagonists

Markers of IBD disease activity and symptoms do not always improve with anti-TNF agents. When IBD is moderate or severe, white blood cells may clump in lesions on the intestinal surface. Integrin receptor antagonists may offer relief for people with IBD who:⁷

• Developed intestinal lesions
• Did not respond well to anti-TNF agents

Integrin receptor antagonists work by binding to proteins that cause inflammation in the intestinal lining. When these proteins are bound, they cannot produce inflammation.⁷

Examples of integrin receptor antagonists include:^2,7

• Entyvio™ (vedolizumab) – for moderate to severe Crohn's disease and UC
• Tysabri^® (natalizumab) – for moderate to severe Crohn's disease

IL-12 and IL-23 inhibitors

Interleukins are immune proteins that play a key role in gut inflammation. IL-12 and IL-23 inhibitors work by blocking interleukins, thus reducing inflammation and symptoms of IBD.^2,8

Examples of IL-12 and IL-23 inhibitors include: ^2,8

• Omvoh™ (mirikizumab-mrkz) – for moderate to severe UC
• Skyrizi® (risankizumab) – for moderate to severe UC
• Stelara® (ustekinumab) – for moderate to severe Crohn's disease and UC
• Tremfya^® (guselkumab) – for moderate to severe UC

What are the possible side effects?

Side effects can vary depending on the specific treatment/drug you are taking. Some of the most common side effects of biologics include:^1,2,6-8

• Upper respiratory infection
• Sinus infection
• Runny nose
• Headache
• Rash
• Diarrhea
• Nausea
• Injection site reactions (redness, itching, swelling)

These are not all the possible side effects of biologics. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment.

Other things to know

Some biologics change the way the body’s immune system works. This can make you more likely to get infections and make it harder to fight them off. Your doctor will monitor you for any signs of infection or other serious side effects during treatment with a biologic.^1,2,6-8

Some biologic drugs can harm an unborn baby. Before starting IBD treatment with a biologic drug, tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. They can help you decide if a biologic drug is right for you.^1,2,6-8
Starting some biologic therapies may impact your ability to receive certain vaccines. Tell your doctor about any vaccines you are scheduled to get before starting treatment.^1,2,6-8

Before beginning treatment for IBD, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.