What to Know About Biologics for Ulcerative Colitis

Ulcerative colitis (UC) is a long-term, chronic inflammatory bowel disease. People with UC can have periods of severe symptoms followed by periods of remission. Since UC is a chronic condition, flares and symptoms are expected to come back, and proper treatment can make the disease easier to live with.

One treatment option for UC is taking biologics. Biologics are different from other drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) or traditional disease-modifying antirheumatic drugs (DMARDs). Depending on the condition, biologics may be a first-line treatment or a treatment option down the line.

Biologics are made from living organisms or components of living organisms. Biologic drugs are sent to specific parts of the inflammatory process to target a particular process instead of affecting the entire body. The three types of biologics used to treat UC are anti-tumor necrosis factor (anti-TNF) agent, integrin receptor antagonists (IRAs), and interleukin (IL) inhibitors.

Uses

Biologics have many medical uses, including for treating some cancers and autoimmune diseases like rheumatoid arthritis (RA), Crohn's disease, psoriasis, ulcerative colitis, and more.

There are around 300 biologics products licensed by the Food and Drug Administration (FDA). Types of biologics approved to treat UC include anti-tumor necrosis factor agents, an integrin receptor antagonist, interleukin-12, and interleukin-23 biologics.

Biologic drugs approved by the FDA for treating ulcerative colitis include:

• Anti-TNF agents: Humira (adalimumab), Simponi (golimumab), and Remicade (infliximab)
• Integrin receptor antagonist: Entyvio (vedolizumab)
• Interleukin-12 and interleukin-23 antagonist: Stelara (ustekinumab)

Off-Label Uses

While not approved, some physicians prescribe biologics to treat other conditions. A 2020 study found effective off-label use in dermatology. Experts expect an uptick in off-label use for inflammatory skin conditions moving forward.

Before Taking

For people with ulcerative colitis, biologics should be used as a first-line treatment for moderate to severe symptoms. This means instead of working up to these drugs after other treatments fail (like NSAIDs and DMARDs), physicians can prescribe biologics first.

Working with a healthcare provider to evaluate the disease activity, other medical concerns, risk factors, and other factors will determine if and when biologics are right for you.

Precautions and Contraindications

While biologics can make enormous positive changes, there are certain precautions you should take:

• Infection: People starting biologics should be aware of the increased risk of infection when taking biologics. Since biologics affect the immune system, they can affect its ability to identify and fend off infections. Additionally, biologics can reactivate prior infections, including tuberculosis and hepatitis.
• Medical history: If you have a history of cancer, diabetes, a heart condition, or a nervous system disorder, your healthcare provider should be aware of that. Current or past treatment for these conditions can put you at greater risk of infection when you're on biologics.
• Vaccinations: Live vaccines aren't recommended when using a biologic. It's suggested that you get these vaccinations at least one month before biologic administration. While this is true, vaccinations are critical to helping you prevent infections since your immune system function is suppressed by biologics.

According to a 2020 review, authors found the rate of serious infection among people taking biologics was low, and they named Entyvio as the safest option for moderate to severe UC.

Be sure to keep up with visits to your healthcare provider and take note of any new or worsening symptoms. Avoid drug interactions by keeping a medication list and sharing medication changes with all the doctors you see.

Special considerations should be made for pregnant people and those who plan to become pregnant. Research is still needed to see what the significant effects or long-term effects of biologics are.

Dosage

Biologics are taken by injection or intravenous (IV) infusion. The dosage depends on the specific biologic:

• Entyvio (vedolizumab) is given via infusion in a doctor's office, at a hospital, or in an infusion center. The recommended dose is 300 milligrams (mg) at zero, two, and six weeks, then eight weeks thereafter. If no improvement is seen, it should be discontinued by week 14.
• Humira (adalimumab) is administered through independent injection (or help from someone else). Humira is started with four injections, followed by two injections two weeks later and then one injection every other week thereafter. Humira needs to be refrigerated before use.
• Remicade (infliximab) is given through IV starting with three doses. After the first dose, the second is administered two weeks later, and the third is four weeks after that.
• Simponi (golimumab) is given through an injection at home. Dosage starts with two injections, then one injection two weeks later, and one injection every four weeks after that. Simponi also must be refrigerated.
• Stelara (ustekinumab) is the last biologic commonly used for UC. It is a combination of injection and infusion. The first dose is given through infusion, and the following dose is given through an injection at home. Stelara must be refrigerated.

Side Effects

Biologics can cause side effects that can be mild to severe. Depending on the biologic, there are different side effects to expect.

Common side effects include:

• Entyvio: Infections, joint pain, nausea, fever, fatigue, cough, and itching with or without rash
• Humira: Pain or irritation at the injection site, headache, rash, and nausea
• Remicade: Abdominal pain, nausea, fatigue, and vomiting
• Simponi: Pain or irritation at the injection site, upper respiratory infection, and viral infections
• Stelara: Injection site reactions, infection, and vomiting
  

Warnings and Interactions

Be aware of the possible side effects of biologics, and speak with your healthcare provider about any therapies you have taken in the past or are currently using. Since biologics compromise the immune system, it is essential to get vaccinated against infections and be aware of new or worsening symptoms.

People on Entyvio should not use other anti-TNF medications, such as Humira (adalimumab), Remicade (infliximab), Simponi (golimumab), Enbrel (etanercept), Cimzia (certolizumab), Gilenya (fingolimod), and others. Combining these medications with Entyvio could increase the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection, and other infections.

Simponi and Humira should also not be combined with Orencia (abatacept), Kineret (anakinra), or other TNF inhibitors.

Stelara should not be used in people with a known hypersensitivity to ustekinumab or any of the drug's inactive ingredients. Stelara should also be used with caution with other immunosuppressive drugs. 

Other drugs that may potentially interact with these biologics include:

• Cyclosporine
• Decadron (dexamethasone)
• Imuran (azathioprine)
• Medrol (methylprednisolone)
• Methotrexate
• Prednisone
• Prograf (tacrolimus)
• Rapamune (sirolimus)
  

A Word From Verywell

Biologics may be the best treatment for your ulcerative colitis if you're living with moderate to severe symptoms. Work with your healthcare provider to find the best treatment for you, and weigh the benefits and shortcomings. Biologics have the potential to greatly improve the quality of life, but research is ongoing. Working with your healthcare team to disclose all past and present treatments is critical to treatment success.