7 Biologics for Ulcerative Colitis: What to Know About Humira, Remicade, and More
Key takeaways:
Ulcerative colitis (UC) is an autoimmune disorder that affects the large intestine. Many medications, including biologic medications, are FDA approved to treat it. Humira (adalimumab), Remicade (infliximab), and Entyvio (vedolizumab) are all common choices.
Biologics for UC work in different ways. Many biologics, such as Humira, reduce immune system activation in general. Others, such as Entyvio, are more specific to your gut.
The best biologic for UC varies for everyone. Your personal preferences, medical history, and specific symptoms are all factors to consider. Your healthcare professional can help you decide which biologic is most appropriate for you.
Ulcerative colitis (UC) is a common autoimmune disorder. The condition prompts your immune system to attack your large intestine, causing inflammation and symptoms such as abdominal pain, diarrhea, rectal bleeding, and more. It’s never ideal when this inflammation is left unchecked.
Thankfully, it doesn’t have to be. Several medications can treat UC — no matter how intense your symptoms are. Oral medications are often recommended for mild to moderate cases of UC. In more severe cases, your healthcare professional may turn to an injectable biologic medication.
Biologics are complex medications that come from living sources. They’re made using cutting-edge biotechnology, and they can treat UC in a few unique ways. Here’s what to know about seven FDA-approved biologics for UC.
1. Humira
Humira (adalimumab) is a popular biologic medication. It’s approved to treat moderately to severely active UC in people ages 5 and older. It can also treat many other inflammatory health conditions, including rheumatoid arthritis, Crohn’s disease, psoriasis, and more.
This treatment belongs to a class of medications known as tumor necrosis factor (TNF) blockers. TNF is an immune system protein that causes inflammation, which can worsen conditions like UC. Humira blocks TNF to lower inflammation and improve gut symptoms like rectal bleeding.
Like other biologics for UC, Humira comes as an injectable medication. It’s given under the skin every week or every other week. It comes in pre-filled syringes and pens that you can administer on your own — without needing to go to your healthcare professional’s office or health clinic.
While Humira is an effective treatment option, it has some possible risks to keep in mind. Most side effects — such as injection site reactions, skin rashes, and headaches — are relatively mild and should go away with time.
Other side effects are more serious. Humira has a boxed warning, the FDA’s most serious medication warning, for serious infections and certain types of cancer. These risks are rare. Still, make sure to let your healthcare professional know if you experience any possible symptoms of infection, such as fever, cough, or shortness of breath.
Humira biosimilars
Many brand-name medications have generic alternatives. In the same light, some biologics have biosimilars. Biosimilars don’t have any meaningful safety or effectiveness differences, and they’re often available at a lower cost.
Many Humira biosimilars became available in the U.S. during the course of 2023. This includes Amjevita, Cyltezo, Hyrimoz, and several others. All of Humira’s biosimilars can treat UC. Anyone with a valid prescription can use GoodRx to purchase two adalimumab-adbm (unbranded Cyltezo) pens at an exclusive cash price of $550.
2. Remicade
Remicade (infliximab) was the first biologic approved to treat UC. It’s another TNF blocker that treats moderately to severely active UC in people ages 6 and older. Remicade also treats other inflammatory health conditions.
Unfortunately, though, you typically can’t administer Remicade on your own. It’s given as an intravenous (IV) infusion. Your healthcare professional will give it to you at an infusion center or health clinic, and each dose takes about 2 hours.
When you’re first starting Remicade, you’ll need to make visits to your infusion center relatively frequently. After your first dose, you’ll need 2 more infusions after 2 weeks and 6 weeks, respectively. After this initial 6-week period, you will settle into a more regular schedule of receiving it every 8 weeks (2 months).
The most common Remicade side effects are infusion reactions, nausea, and headaches. Remicade also has boxed warnings for potentially serious infections and cancer — similar to Humira. Your healthcare professional can help you manage and prevent rare risks like these.
Remicade biosimilars
Depending on where you receive your infusions, you may receive Remicade or a Remicade biosimilar. Available options include Inflectra, Renflexis, and Avsola. All three are approved to treat UC.
What’s more, an under-the-skin version of Inflectra has also been approved. It’s called Zymfentra. You can self-administer it at home.
3. Simponi
Simponi (golimumab) is another TNF-blocking UC medication. But it’s only approved for adults. It can also treat rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.
If your healthcare professional prescribes Simponi for moderately to severely active UC, you’ll inject it under your skin using an autoinjector or pre-filled syringe. You’ll likely inject your first 2 doses 2 weeks apart. After that, you can inject it as infrequently as every 4 weeks.
The most common Simponi side effects are injection site reactions and common cold symptoms. Similar to other TNF blockers, it also has boxed warnings for potentially serious infections and cancer. While these risks are rare, make sure to tell your healthcare professional if you’re feeling sick or experience anything out of the ordinary.
4. Entyvio
Entyvio (vedolizumab) is a different type of biologic for UC and Crohn’s disease. Because of how it works, Entyvio is the only UC biologic that’s “gut-specific.” It doesn’t have significant effects on other parts of your body.
This injectable product works by blocking integrins, which are proteins that live on certain inflammation-causing immune cells. These integrins act like house keys, giving your immune system access to your large intestine. When you receive Entyvio, you essentially “change the locks” and prevent immune cells from using the keys to enter your gut. This helps lessen inflammation from UC.
The side effects possible with Entyvio are different from other biologics for UC. It doesn’t have boxed warnings for serious infections or cancer. Infections are still possible, but the risk is less substantial compared to TNF-blocking medications. Some of Entyvio’s most common side effects are mild infections, headache, and body pain.
Entyvio is given as an IV infusion that’s administered by a healthcare professional. Your first 3 infusions will take place across a 6-week time period. After your third infusion, they’ll likely administer Entyvio every 8 weeks. Each infusion should only take about 30 minutes.
5. Stelara
Stelara (ustekinumab) is another biologic for UC. It’s approved to treat adults with moderately to severely active UC. Stelara also treats psoriatic arthritis, psoriasis, and Crohn’s disease.
It works in a unique way, too. Your immune system uses proteins called interleukins to send messages and communicate with itself. These messengers can activate your immune system and cause inflammation. Stelara blocks two of these proteins — IL-12 and IL-23 — to calm inflammation and gut symptoms from UC.
If Stelara ends up being the next step in your treatment plan, you’ll likely receive your first dose as an IV infusion. Your healthcare professional will infuse it into a vein over 1 hour. After this initial dose, you can inject Stelara under your skin at home every 8 weeks for maintenance treatment.
Some of Stelara’s most common side effects are headaches, common cold symptoms, and stomach pain. It’s occasionally been linked to more serious infections and cancer, but the risk is lower than with TNF blockers. Your healthcare professional will work with you to prevent these risks.
Stelara biosimilars
The FDA approved the first Stelara biosimilar in late October 2023. It’s called Wezlana (ustekinumab-auub). It’s approved to treat the same health conditions as Stelara, and the two are even interchangeable. However, due to patent restrictions, Wezlana likely won’t be commercially available in the U.S. until early 2025.
Another interchangeable Stelara biosimilar, called Pyzchiva (ustekinumab-ttwe), was approved to treat UC more recently. It’s set to launch in February 2025.
6. Omvoh
Omvoh (mirikizumab) is a newer biologic medication for UC. Like Wezlana, it was approved in late October 2023. It can treat adults that are living with moderately to severely active UC.
This medication is slightly different from many other UC biologics. It blocks an interleukin called IL-23p19 to lessen intestinal inflammation. It can help improve UC-related symptoms, such as bowel urgency, and help people enter remission.
One downside is that Omvoh’s initial dosages are somewhat complex. But they become more simple over time. Here’s a three-step breakdown of how Omvoh dosages work:
Your first three doses of Omvoh are given as an IV infusion. Each infusion is spaced apart by 4 weeks and should take at least 30 minutes to receive. Your healthcare professional will administer these doses to you.
Your fourth dose of Omvoh will be injected under your skin using a prefilled injection pen. This dose will take place 4 weeks after your last Omvoh infusion.
From this point on, you’ll inject Omvoh under your skin once every 4 weeks. Each monthly dose will consist of two back-to-back injections. This is considered your “maintenance” dose.
Omvoh’s side effects are somewhat comparable to Stelara’s side effects. The most common side effects in clinical trials were common cold symptoms, joint pain, and injection site reactions. Omvoh may also increase the risk of infection and liver problems.
7. Skyrizi
Skyrizi (risankizumab) is a biologic that treats several health conditions, including UC. It was approved to treat moderately to severely active UC in adults in June 2024.
Skyrizi lessens gut inflammation by blocking IL-23p19, similarly to Omvoh. However, unlike Omvoh, Skyrizi is approved to treat both forms of inflammatory bowel disease (IBD) — Crohn’s disease and ulcerative colitis.
If you’re prescribed Skyrizi for UC, you’ll likely receive your first three doses as an IV infusion. These three doses will be spaced apart over an 8-week timeframe. After that, you can self-administer your maintenance doses under the skin. Your first maintenance dose should take place about 4 weeks after your last infusion. After that, you’ll likely be told to inject Skyrizi every 8 weeks. You can administer these doses using a prefilled syringe or on-body injector.
Injection site discomfort, joint pain, and skin rashes are some of Skyrizi’s most common side effects. It may also increase the risk of infection.
How do you know which ulcerative colitis biologic is right for you?
The best biologic for UC isn’t straightforward. It depends on many factors. Medications you’ve tried in the past, the severity of your symptoms, and other medical conditions you have can all take center stage. Your personal preferences and your insurance plan’s formulary are important, too.
Still, the American Gastroenterological Association has some general suggestions on how to use biologics in moderately to severely active UC:
If you’ve never tried a biologic before and you’re looking to enter remission (get rid of your symptoms), Remicade or Entvyio may be your best bets. Humira is a good alternative if you want a more convenient option.
If a medication like Remicade didn’t help you enter remission, Stelara is one of several options to try next.
If you’re in remission (currently symptom free), there’s no specific recommendation on what to use. Any of the approved biologics could be considered. If a certain medication is already working well, you’ll likely keep using it.
Selecting a biologic can take some trial and error. A medication that successfully treats UC for someone else may not be as beneficial for you — and vice versa. In most cases, you’ll make a collaborative decision about the best biologic for you with your healthcare professional.
The bottom line
Many biologics can treat moderately to severely active ulcerative colitis (UC), an autoimmune disorder that affects the large intestine. Humira (adalimumab), Remicade (infliximab), and Simponi (golimumab) are three common examples. Stelara (ustekinumab), Omvoh (mirikizumab), and Skyrizi (risankizumab) are newer biologics that are beneficial, too. The best biologic for UC depends on factors that are specific to your circumstances.
Why trust our experts?
References
AbbVie Inc. (2021). Humira - adalimumab injection, solution [package insert].
AbbVie Inc. (2024). Skyrizi - risankizumab-rzaa injection [package insert].
Amgen Inc. (2023). Avsola - infliximab-axxq injection, powder, lyophilized, for solution [package insert].
Awan, H., et al. (2023). The efficacy of currently licensed biologics for treatment of ulcerative colitis: A literature review. Cureus.
Centocor, Inc. (2007). Remicade becomes first anti-TNF biologic therapy to treat 1 million patients worldwide. EurekAlert.
Cheng, D., et al. (2022). Risk of infections with ustekinumab and tofacitinib compared to tumor necrosis factor α antagonists in inflammatory bowel diseases. Clinical Gastroenterology and Hepatology.
Eli Lilly and Company. (2023). Omvoh - mirikizumab-mrkz injection, solution [package insert].
Entyvio. (n.d.). Mechanism of action.
Feuerstein, J. D., et al. (2020). AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterology.
Godron, K. B., et al. (2012). Long-term safety experience of ustekinumab in patients with moderate to severe psoriasis (Part II of II): Results from analyses of infections and malignancy from pooled phase II and III clinical trials. Journal of the American Academy of Dermatology.
Healio. (2024). Skyrizi snags FDA approval for moderate to severe UC; first IL-23 approved for UC, CD.
Janssen Biotech, Inc. (2022). Remicade - infliximab injection, powder, lyophilized, for solution [package insert].
Janssen Biotech, Inc. (2022). Stelara - ustekinumab injection, solution [package insert].
Janssen Biotech, Inc. (2023). Simponi - golimumab injection, solution [package insert].
Jeremias, S., et al. (2023). FDA approves first subcutaneous infliximab product. American Journal of Managed Care.
Ko, C. W., et al. (2018). AGA clinical practice guidelines on the management of mild-to-moderate ulcerative colitis. Gastroenterology.
Lilly. (2023). FDA approves Lilly's Omvoh (mirikizumab-mrkz), a first-in-class treatment for adults with moderately to severely active ulcerative colitis.
Managed Healthcare. (2023). FDA approves first interchangeable Stelara biosimilar.
Managed Healthcare. (2023). Lilly’s first-in-class therapy for ulcerative colitis get FDA approval.
Organon LLC. (2022). Renflexis - infliximab injection, powder, lyophilized, for solution [package insert].
Pfizer Laboratories Division, Pfizer Inc. (2023). Inflectra - infliximab-dyyb injection, powder, lyophilized, for solution [package insert].
Shah, E. D., et al. (2017). Risk for overall infection with anti-TNF and anti-integrin agents used in IBD: A systematic review and meta-analysis. Inflammatory Bowel Diseases.
Takeda Pharmaceuticals America, Inc. (2022). Entyvio - vedolizumab injection, powder, lyophilized, for solution [package insert].
U.S. Food and Drug Administration. (2023). FDA approves interchangeable biosimilar for multiple inflammatory diseases.
