7 Biologics for Crohn’s Disease: Why Remicade, Stelara, and More Can Make a Difference
Key takeaways:
Biologics are first-choice treatment options for moderate-to-severe Crohn’s disease. Seven biologics are currently FDA approved to treat it.
Humira (adalimumab), Remicade (infliximab), and Stelara (ustekinumab) are a few examples of biologics that manage moderate-to-severe Crohn’s disease. The best biologic for you depends on factors such as your age, personal preferences, and health background.
Specific side effects vary by medication. But injection site pain, headache, and fever are a few examples of common biologic side effects.
Table of contents
Crohn’s disease is an autoimmune disorder that causes inflammation in the gastrointestinal (GI) tract. This often causes uncomfortable GI symptoms, such as stomach pain and diarrhea. In more severe cases, the GI tract gets damaged.
Although there isn’t a cure for Crohn’s disease, there are medications — such as biologics — that can help manage symptoms and address underlying inflammation. Biologics are complex medications that work by calming down an overactive immune system. They’re considered first-choice treatment options for moderate-to-severe Crohn’s disease. Research shows they can help you become symptom-free (reach remission) sooner, especially if they’re started early.
Knowing more about seven popular biologics for Crohn’s disease can help you decide if one is right for you or a loved one.
1. Humira
Humira (adalimumab) is FDA approved to manage moderate-to-severe Crohn’s disease in adults and kids ages 6 years and older. It lessens inflammation by blocking an immune system protein called tumor necrosis factor (TNF).
You can administer Humira to yourself, which isn’t always the case with biologics. Humira comes as an injection that’s administered into the fat under the skin (subcutaneously) every other week. Your pharmacist or healthcare provider can show you how to give yourself a Humira injection. You can also contact 1-800-4HUMIRA (1-800-448-6472) with any questions.
Humira’s design is effective for many people. The American Gastroenterological Association (AGA) recommends it as a go-to medication for moderate-to-severe Crohn’s disease. One large study found that Humira was effective for at least 6 years.
Good to know: Humira should typically be refrigerated. But if you’re traveling, you can store Humira at room temperature for up to 14 days (2 weeks) in its original carton.
Humira biosimilars
Like generic versions of brand-name medications, biosimilars help make biologic medications more affordable and accessible. They’re very similar to their original (reference) biologic medication in terms of safety and effectiveness.
Here are nine approved Humira biosimilars:
Amjevita (adalimumab-atto)
Cyltezo (adalimumab-adbm)
Hyrimoz (adalimumab-adaz)
Hadlima (adalimumab-bwwd)
Abrilada (adalimumab-afzb)
Hulio (adalimumab-fkjp)
Yusimry (adalimumab-aqvh)
Idacio (adalimumab-aacf)
Yuflyma (adalimumab-aaty)
2. Remicade
In 1998, Remicade (infliximab) became the first biologic approved for Crohn’s disease. It shares several similarities with Humira. It’s a TNF blocker that treats moderate-to-severe Crohn’s disease in adults and kids ages 6 years and older. And it’s a first-choice treatment option.
One of the key differences between Remicade and Humira is that Remicade is given as an intravenous (IV) infusion in a medical setting. You can’t inject it at home. Typically, you’ll start off with 3 “loading” infusions spread out over 6 weeks. After that, you’ll usually receive it once every 8 weeks (2 months) for maintenance treatment. Research shows that Remicade is effective at helping people with Crohn’s disease reach remission.
Good to know: Each Remicade infusion takes about 1 to 2 hours to receive. If you have a hectic daily schedule, make sure to take this into account.
Remicade biosimilars
Humira isn’t the only Crohn’s biologic with biosimilars available. Check out the four approved Remicade biosimilars:
Inflectra (infliximab-dyyb)
Renflexis (infliximab-abda)
Avsola (infliximab-axxq)
Ixifi (infliximab-qbtx)
Ixifi likely won't be available in American clinics and infusion centers. It's produced by the same company that manufactures Inflectra.
Good to know: Zymfentra (infliximab-dyyb) is another new option to consider. It’s an under-the-skin, injectable version of infliximab that was modeled after Inflectra. It’s not technically a biosimilar, though, because of how it’s administered.
3. Cimzia
Cimzia (certolizumab pegol) is another TNF blocker. It’s approved to manage moderate to severe Crohn’s disease in adults specifically.
Cimzia comes as a subcutaneous injection that’s initially given every 2 weeks. If the medication ends up working for you, you’ll give yourself an injection every 4 weeks (1 month) as maintenance treatment. You can conveniently self administer this medication at home. Talk to your pharmacist or healthcare provider before starting treatment with Cimzia to make sure you have the technique down.
Cimzia likely won’t be the first biologic you try for Crohn’s disease. The AGA generally recommends other biologics — like Humira — over Cimzia. This is because Cimzia may not be as effective as some other biologics at helping people reach remission.
4. Entyvio
Entyvio (vedolizumab) behaves differently than Humira, Remicade, and Cimzia. It’s an integrin receptor blocker. It blocks certain immune cells from entering the GI tract and causing inflammation in Crohn’s disease.
Entyvio is administered as an IV infusion. After three initial doses given over the course of 6 weeks, you’ll likely get an infusion every 8 weeks (2 months) for maintenance treatment. Each infusion takes about 30 minutes. An under-the-skin version may be an option in the near future.
The AGA recommends Entyvio as a treatment option for adults with moderate-to-severe Crohn’s disease. One large review found that Entyvio is effective for helping people with Crohn’s disease reach remission — and helping them stay there. Your healthcare provider can help you decide if and when Entyvio would be the next step in your treatment plan.
Good to know: If your symptoms aren’t improving after 14 weeks (3 to 4 months), talk with your healthcare provider about switching to a different biologic. In some cases, Entyvio is given more often than every 8 weeks to better control symptoms, but this approach isn’t FDA approved.
5. Tysabri
Tysabri (natalizumab) is another integrin receptor blocker for moderate-to-severe Crohn’s disease in adults. It’s given as an IV infusion every 4 weeks. Each infusion takes about 1 hour to finish.
Research shows Tysabri is effective for managing Crohn’s disease. But it carries the risk of a serious brain infection called progressive multifocal leukoencephalopathy (PML). For this reason, Tysabri is only available through a restricted program called the TOUCH Prescribing Program.
Tysabri typically isn’t recommended for Crohn’s disease because of this risk. But it may be an option if you can’t receive other biologics.
Tysabri biosimilars
In August 2023, the FDA approved the first Tysabri biosimilar, known as Tyruko (natalizumab-sztn). Tyruko is expected to become available in the U.S. during the first half of 2024.
6. Skyrizi
Skyrizi (risankizumab) lowers inflammation by blocking a protein called interleukin-23 (IL-23). It’s dubbed an “IL-23 blocker.”
Skyrizi is another approved treatment for moderate-to-severe Crohn’s disease in adults. But its dosages are unique. Three starter doses are administered as an IV infusion. After this, you can administer Skyrizi at home, as a subcutaneous injection, every 8 weeks.
Two phase 3 trials showed Skyrizi was effective for managing Crohn’s disease. The medication isn’t officially included in clinical guidelines yet, but your healthcare provider may recommend Skyrizi if TNF blockers like Humira don’t work for your symptoms.
7. Stelara
Stelara (ustekinumab) is similar to Skyrizi. It blocks IL-23, but it also blocks a protein called IL-12. Stelara helps lower inflammation by interfering with both of these inflammatory proteins.
The AGA recommends Stelara as a possible first-choice biologic for moderate-to-severe Crohn’s disease in adults. If your healthcare provider recommends Stelara, you’ll likely start with an IV infusion for your first dose. After this one time infusion, you can administer Stelara at home as a subcutaneous injection every 8 weeks.
You should store your Stelara injections in the refrigerator when possible, but one injection can be left at room temperature for up to 30 days in the original carton. The manufacturer says you shouldn’t put a dose back in the refrigerator after it’s been stored at room temperature.
Stelara biosimilars
In late October 2023, the FDA approved Wezlana (ustekinumab-auub), the first Stelara biosimilar. It’s considered to be interchangeable with Stelara: The two are used the same way and are approved to treat the same health conditions, including Crohn’s disease.
Wezlana won’t be available right away, though. Due to patent limitations, it likely won’t be available for purchase in the U.S. until early 2025.
What are the side effects of biologics for Crohn’s disease?
Like all medications, biologics can cause side effects. Specific side effects vary by medication. But common ones include:
Injection site pain, swelling, and redness
Headache
Fever
Chills
Rash
Infusion reactions can also happen when receiving an IV biologic. They can happen during or after your infusion. You’ll be monitored closely for signs of a reaction during your clinic visit. Let your healthcare provider know if you experience swelling, redness, or itching after you leave.
Serious biologic side effects
Biologics for Crohn’s disease can weaken your immune system, making it harder to fight off infections. Before starting a biologic, your provider will likely test you to make sure your risk from an infection like tuberculosis (TB) or hepatitis B is low.
Other issues are also possible, albeit rare. Check out the table below for some examples of rare but serious side effects that have been reported with Crohn’s disease biologics.
Biologic | Serious side effect |
|---|---|
Humira | Lymphoma, drug-induced lupus |
Remicade | Heart problems, lymphoma, liver damage |
Cimzia | Lymphoma |
Entyvio | Liver damage, pancreas inflammation |
Tysabri | PML, liver damage, bleeding risk |
Skyrizi | |
Stelara | Posterior reversible encephalopathy syndrome (a brain condition) |
Reach out to your provider about any new or worsening symptoms — including a fever, cough, or skin infection — while you’re receiving a biologic.
How do I know which Crohn’s disease medication is right for me?
The best biologic for you boils down to a variety of different factors, such as age, health conditions, and personal preferences. The specific symptoms you’re experiencing, alongside your insurance plan’s formulary, can also play big roles.
For instance, if your 6-year-old child needs a biologic, Humira and Remicade could be options. Or, if you’re living with heart failure, Remicade may not be the best option because it can make your symptoms worse. And if you’re looking for a convenient, at home option, Humira or Cimzia could be ideal choices.
The bottom line
Seven biologics are currently FDA approved to manage moderate-to-severe Crohn’s disease. They’re administered by an IV infusion or under-the-skin injection. Humira, Remicade, and Stelara are examples of first-choice treatments for managing Crohn’s disease. Talk with your healthcare provider about which biologic is right for you.
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