| Brand | Generic | Administration | How Often? |
| Remicade | Infliximab | IV infusion at clinic | Induction: Initial dose, 2nd dose two weeks later, and 3rd dose four weeks after that; Maintenance: Every eight weeks |
| Humira | Adalimumab | Subcutaneous (SQ) at home | Induction: Initial dose, then 2nd dose two week later; Maintenance: Start two weeks after 2nd dose, every other week |
| Simponi | Golimumab | Subcutaneous (SQ) at home | Induction: Initial dose, then 2nd dose the two weeks later; Maintenance: Every 4 weeks after the 2nd dose |
Infliximab
If you have never been on a biologic before, infliximab is the first one you might try for ulcerative colitis.
Infliximab has been the standard therapy in treating ulcerative colitis due to a study called ACT-1 and ACT-2.
According to the results, infliximab controlled ulcerative colitis symptoms much better than a placebo (non-therapeutic substance). In ACT-1 and ACT-2, 60-70% of infliximab users achieved clinical response compared with 29% and 37% of placebo users, respectively.
The results of this trial prompted the FDA to approve infliximab as a treatment for moderate to severe ulcerative colitis.
Adalimumab
Adalimumab (brand name Humira) is an anti-TNF alpha agent that can be used for moderate-to-severe ulcerative colitis.
While infliximab is the biologic of choice, Humira is an option if you do not want to go into a clinic to get IV infusions. With Humira, you have the flexibility to administer your medication at home via an injection into the fatty tissue.
Two main clinical trials determined the efficacy of adalimumab. The first trial concluded that 18.5% of only participants had seen the benefits of adalimumab after eight weeks of treatment compared with 9.2% in the placebo group.
However, another trial was conducted, ULTRA-2. The ULTRA-2 study found that adalimumab provided a clinical response in 50.4% of participants compared with 34.6% on placebo at week eight.
Golimumab
Golimumab, or Simponi, is an anti-TNF alpha agent for moderate-to-severe ulcerative colitis.
Similar to Humira, Simponi is administered via an injection in the fatty tissue. Simponi can be used after you tried Remicade and did not receive enough relief from the medication.
The PURSUIT trial determined about 27.8% of users on 100 milligrams (mg) of golimumab were able to see improvements in ulcerative colitis by week 30 of treatment. This was compared to 15.6% of people who took a placebo.
Integrin Receptor Antagonists
Entyvio, also known as vedolizumab, is a different type of biologic that blocks integrin adhesion molecules.
Integrin adhesion molecules are proteins that help inflammatory cells bind to gut tissues. Integrin receptor antagonists attack the integrin protein, preventing inflammatory cells from interacting with tissues in the gut. As a result, there is a decrease in inflammation in the colon and rectum.
Entyvio may be used if you did not respond to an anti-TNF alpha agent or if the medication stopped working.
Vedolizumab and infliximab are considered superior to other biologics based on a study called GEMINI-1. The study concluded that 47% of people had clinical benefits after six weeks of vedolizumab therapy.
Entyvio is given as an IV infusion at a clinic every eight weeks.
Interleukin Inhibitors
Stelara, also known as ustekinumab, is a monoclonal antibody that targets specific proteins called interleukin-12 (IL-12) and interleukin-23 (IL-23).
Interleukins are signal molecules of the immune system that regulate immune responses, inflammation, and blood cell production.
In ulcerative colitis, the main interleukins that cause inflammation are IL-12 and IL-23. Interleukin inhibitors weaken the signal for the immune system to cause inflammation. It is recommended to consider Stelara after you have tried and failed to respond to an anti-TNF alpha agent or other biologic agents.
According to Stelara’s clinical trials, users saw improvement in their ulcerative colitis after eight weeks of treatment. Participants in the studies had previously tried a biologic (such as an anti-TNF agent or vedolizumab) and other standard therapy, such as corticosteroids.
When first starting Stelara, it is given as a single IV dose, followed by a subcutaneous injection every eight weeks.
Janus Kinase Inhibitors
Xeljanz, also known as tofacitinib, is a Janus kinase (JAK) inhibitor used for moderate-to-severe ulcerative colitis. JAK inhibitors work by blocking the signal pathways involved in inflammation.
Xeljanz is used after you have tried and failed to respond to anti-TNF alpha agents or other biologics.
The main benefit of using Xeljanz is its convenience compared with other biologics. It can be taken as a pill by mouth twice daily. However, many risks may prevent someone from using Xeljanz. Limitations of Xeljanz include the increased risk of infections, cancer, blood clots, and treatment-related death.
While Xeljanz is an option in treating ulcerative colitis, it may not be the safest choice. You should always talk to your healthcare provider about the risks and benefits of taking any biologic.
Based on Xeljanz clinical trials, about 60% of users could see improvements in their ulcerative colitis symptoms after eight weeks of therapy.
Side Effects
Depending on which biologic you take, you may experience different side effects. These can range from mild to more severe and can vary from person to person.
The most common side effects for each biologic are listed below.
| Infliximab | Adalimumab | Golimumab | Vedolizumab | Ustekinumab | Tofacitinib | |
| Cough | X | |||||
| Fever | X | X | ||||
| Headache | X | X | X | X | X | |
| Infection (e.g., upper respiratory infection) | X | X | X | X | X | |
| Infusion or injection site reaction | X | X | X | |||
| Itchiness | X | |||||
| Joint pain | X | |||||
| Nausea | X | X | ||||
| Nose or throat irritation | X | X | ||||
| Rash | X | X | ||||
| Stomach pain | X | X | ||||
| Tiredness | X | X |
Interactions
Before starting biologics, it is important to talk to your healthcare provider about any medications that you have taken in the past or are currently taking to avoid any interactions. Since biologics weaken the immune system, it is recommended to be up to date with all your vaccinations to avoid the risk of getting sick.
Live vaccines are the only vaccines you should avoid while on a biologic. If you plan on getting a live vaccine, it is recommended to get it six weeks before starting the biologic.
You should not combine any biologic agents together. Combining biologics does not make the medications work better. In fact, using multiple biologics together can increase the risk of life-threatening infections, cancer, and damage to the liver.
Can Biologics Be Combined With Other Therapies?
Other medications, called immunosuppressants, can be used to help manage ulcerative colitis.
Immunosuppressants can control inflammation by decreasing the immune system’s inflammatory response. Commonly used immunosuppressants include:
- Lialda (mesalamine)
- Imuran (azathioprine)
- Sandimmune (cyclosporine)
There is clinical uncertainty about combining biologics and immunosuppressants. Emerging studies indicate that the combination of infliximab and azathioprine had better healing rates in ulcerative colitis than using infliximab alone.
However, a limitation of combining biologics and immunosuppressants is the risk of easily getting sick since your immune system is weakened. In addition, limited studies indicate optimal medication management when using both types of medications.
How Much Do Biologics Cost?
While biologics are effective medications, they can be expensive. Based on a 2016 study comparing the cost of different biologics, these medications can range from $928 to $2,700 per dose.
Fortunately, many medical insurances may cover a portion of the cost of biologic therapy. However, what your insurance will cover is not always guaranteed, and costs may still be high.
Due to the high costs of biologics, your healthcare provider may consider trying a biosimilar instead. Biosimilars are nearly identical to biologics and are close to being a “generic” version of the initial product. They are made up of the same biologic components and work the same. The main benefit of biosimilars is that they are less expensive than biologics.
Summary
Biologics are commonly used to control inflammation caused by ulcerative colitis. Various biologics are used in ulcerative colitis, including anti-TNF alpha agents, integrin receptor antagonists, interleukin inhibitors, and Janus kinase inhibitors.
Each type of biologic has its own unique characteristics, such as form of administration, how it works, and side effects.
Although generally considered safe, it’s important to be aware of potential side effects and risks. For example, you shouldn’t combine biologics with other biologics or live vaccines.
Talk with your healthcare provider about medications, over-the-counter products, and supplements you are currently taking or vaccines you plan to get.
The author would like to recognize and thank Alexya Rosas for contributing to this article.
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