The introduction of biologics has changed treatment for many people with ulcerative colitis. Here’s what you need to know about the risks and benefits.
Over the past 15 years, treatment options for ulcerative colitis (UC) have expanded quite a bit. Among the most common options is a class of drugs called biologics.
Biologics are derived from natural sources, such as human or animal genes or microorganisms, and are designed to act on the immune system, specifically the parts that play key roles in fueling inflammation.
“As inflammation is thought to be a cornerstone of the process involved in the manifestation of inflammatory bowel diseases, like Crohn’s disease and ulcerative colitis, [biologics] have proved to be very effective as treatment for certain patients,” says Donald Tsynman, MD, a gastroenterologist at NewYork-Presbyterian Hospital in New York City.
Biologics target the inflammatory activity of a person's own immune system, setting them apart from other medications for ulcerative colitis, Dr. Tsynman says.
How Biologics Work
“The biologics that have been approved for Crohn’s and ulcerative colitis involve antibodies that are developed in the lab to target proteins related to inflammation,” says Joel Pekow, MD, a gastroenterologist and an associate professor of medicine at the University of Chicago.
The biologics that are now approved by the U.S. Food and Drug Administration (FDA) for treating ulcerative colitis include:adalimumab (Humira), golimumab (Simponi), infliximab (Remicade)vedolizumab (Entyvio), ustekinumab (Stelara), risankizumab (Skyrizi), guselkumab (Tremfya)
Many biologics, including Humira, Simponi, and Remicade, work by targeting a protein called tumor necrosis factor alpha, which contributes to inflammation.
Another way that biologics target inflammation is by addressing the problem of too many white blood cells in the gastrointestinal tract. Vedolizumab works this way — it blocks these inflammatory cells from getting into the gut.
A scientific review that examined the safety and efficacy of Humira, Simponi, Remicade, and Entyvio found that all four biologics were effective at treating moderate to severe UC, and all were comparatively safe.
Skyrizi is one of the newer biologics on the block. On June 18, 2024, AbbVie, a pharmaceutical company, announced that the FDA had approved Skyrizi for adults with moderate to severely active UC, making it the first IL-23-specific inhibitor approved for both moderate to severe UC and moderate to severe Crohn's disease. This drug helps limit the inflammation processes that can make inflammatory bowel disease symptoms worse.
Tremfya is another newly FDA-approved biologic for UC. On September 11, 2024, the pharmaceutical company Johnson & Johnson announced that the FDA had approved Tremfya to treat adults with moderately to severely active ulcerative colitis.
Tremfya was later FDA-approved on March 20, 2025, for moderate to severe Crohn’s disease, too. Like other biologics, Tremfya is designed to limit UC-related inflammation.
The Advantages of Biologics for Ulcerative Colitis
Biologics can improve gut symptoms and bring about and maintain remission (prevent flares) in people with moderate to severe UC.
One advantage of biologic therapies over other treatments for UC is that they are more precisely targeted to the factors responsible for the condition.
Unlike corticosteroids — which affect the whole body, can cause significant side effects, and are not meant for long-term use — biologic agents act more selectively. These therapies are targeted to particular proteins that are known to be involved in UC.
“Patients are often nervous about biologics,” says Laura Raffals, MD, a gastroenterologist at the Mayo Clinic in Rochester, Minnesota. “But they’re not as scared about taking a corticosteroid, and that’s an important conversation to have because the data shows that patients on biologics are much safer and stay in remission longer. The serious side effects we see are from steroids or narcotics, not biologics.”
The Potential Downsides of Biologics
While biologics may be a promising option for treating UC, not every drug is suited to every patient. Dr. Raffals says, “We will work with patients for a while to tailor a treatment plan that is right for them. That may mean trying different biologics and small-molecule drugs,” such as upadacitinib (Rinvoq), tofacitinib (Xeljanz), or ozanimod (Zeposia). And of course, she adds, “taking into account what the patient’s insurance will cover.”
A person’s lifestyle, demographic factors such as age, other medical conditions such as a history of cancer or being immunocompromised, and the severity of the disease are all considerations in the choice of whether to use biologics and which is the best option.
Some potential downsides of taking biologics include:
Lack of Long-Term Data While studies and clinical information indicate that biologics are generally safe, they are relatively newer drugs, so with the exception of Remicade, long-term safety information is scarce.
Cost Because most of these drugs are available only as name brands, they can be very expensive. The introduction of biosimilars — medicines that are very similar to an original biologic therapy that is no longer patented — for Remicade and Humira has increased competition in the biologics market, with an aim to bring down the cost of this type of therapy.
Method of Treatment Taking biologics isn't as simple as swallowing a pill. Some biologics, such as Humira and Skyrizi, can be self-administered via an at-home injection, while others, like Entyvio, require intravenous infusion, though a new subcutaneous option is available as well for Entyvio. Your level of comfort or schedule may influence your choice between biologics or whether to take them at all.
Side Effects: As with all medications, biologics come with potential side effects. These include redness or itchiness at the injection site, increased susceptibility to infection, and a low increased risk of cancer.
If you’re considering biologics for treatment, speak to your doctor to find out what’s best for you. “At the heart of the decision is the relationship between the patient and the physician and specifically exploring what works best for each individual,” Tsynman says.
The Takeaway
Biologics can help you better manage the symptoms of moderate to severe UC. They directly target factors that are responsible for the condition, unlike other medications that affect the whole body and have significant side effects.
Biologics come with potential downsides, like the need for injections, high costs, and side effects such as increased susceptibility to infection.
There are now many options that can be tailored to fit your needs. Discuss with your doctor which treatment best suits your health needs.
As Always Stay Safe, Stay Healthy and Be Careful out there
James A Vito, DMD