Uc biologics: 10 Things to Know About Biologics for Ulcerative Colitis
10 Things to Know About Biologics for Ulcerative Colitis
If you have moderate to severe ulcerative colitis (UC) and aren’t responding to or can’t tolerate the side effects of traditional medications, such as aminosalicylates (5-ASAs) or immunomodulators, your doctor may start you on a biologic.
Biologic drugs, such as Humira (adalimumab), Simponi (golimumab), Remicade (infliximab), Entyvio (vedolizumab), and Stelara (ustekinumab), can alleviate inflammation and keep your disease in remission if other UC medications aren’t effective.
But these drugs are also complex and may not work for everyone, so it’s important to learn more about them if you’re new to biologic therapy.
Here are 10 key facts about biologic drugs for UC.
1. Biologics Aren’t Considered a First-Line Treatment
Although many doctors believe it’s better to start a biologic drug sooner rather than later, it’s not likely to be your first ulcerative colitis treatment. “The current indications for biologics in ulcerative colitis are for people who haven’t responded to traditional medications or are dependent on corticosteroids to relieve their symptoms,” says Thomas Ullman, MD, the chief of the division of gastroenterology at the Albert Einstein College of Medicine in New York City.
It’s possible, though, that your doctor will recommend a biologic early in the course of your treatment if your ulcerative colitis reaches a certain threshold of severity. This decision will likely depend on your doctor’s personal judgment and experience.
2. Biologics Are Targeted Medications
While many UC medications have wide-ranging effects on your immune system, biologics are designed to block specific steps in the inflammatory process.
One group of biologic drugs for UC, known as anti-TNF drugs or TNF inhibitors, block a protein called tumor necrosis factor alpha (TNF alpha) that promotes inflammation in your intestines and certain other organs. Anti-TNF drugs include Humira, Simponi, and Remicade. Another type of biologic, Entyvio, is an integrin receptor antagonist, which works by blocking a protein on the surface of cells that can move out of blood vessels and into certain tissues. The newest biologic approved to treat UC, Stelara, blocks interleukin-12 and interleukin-23, proteins known to be involved in immune responses in inflammatory bowel disease (IBD) like UC.
3. Biologics Are Given by Injection
Some biologic medications are available as a shot that’s given from several times a month to once every three months, with more frequent “starter” doses in the beginning. You or a loved one can learn to administer these injections at home. Other biologics require an intravenous (IV) infusion, which typically happens every eight weeks after several initial infusions. Depending on the drug, an infusion can last about 30 minutes or two to four hours.
4. Biologics May Be Used Along With Other UC Medication
“A biologic medication combined with a traditional ulcerative colitis drug may work better than either drug alone,” Dr. Ullman says, but two biologics shouldn’t be taken together because of an increased risk of complications.
Current guidelines from the American College of Gastroenterology (ACG) also state that if you previously took a 5-ASA that wasn’t successful, you shouldn’t keep taking it if you move on to an anti-TNF drug, such as adalimumab or infliximab.
5. It May Take Time for Biologic Drugs to Take Effect
When you start taking an anti-TNF drug, it may take up to eight weeks before you notice any improvement in your UC symptoms, according to the Crohn’s & Colitis Foundation. While some people notice an immediate improvement, the possibility of a delayed effect means you’ll need to continue your treatment for several weeks before you determine it isn’t effective.
6. You May Need to Try Different Biologics
If one biologic doesn’t work for you, your doctor may suggest raising the dose or decreasing the interval between doses, or switching to another drug. The ACG guidelines also suggest that if anti-TNF therapy isn’t effective, you may want to try Entyvio. But because there are so many individual variations in Crohn’s and colitis patients, the ultimate decision is between you and your doctor.
7. Biologic Therapy Can Lead to Long Periods of Remission
Biologics are broadly effective at reducing chronic inflammation in UC.
“We’re seeing fewer hospital admissions, fewer surgeries, and less disability from ulcerative colitis with the use of these drugs,” says Ullman.
They are also long-term maintenance drugs, so once you start on biologic therapy, you’ll need to keep taking it to prevent your UC from flaring. Don’t stop treatment without consulting with your doctor.
8. Biologics May Become Less Effective Over Time
While it isn’t exactly clear why, some people have an initial response to a biologic but lose this response over months or years of treatment. When this happens with an anti-TNF drug, your doctor may recommend trying a different anti-TNF drug or a different type of biologic like Entyvio or Stelara.
9. Biologics Have Some Side Effects and Long-Term Risks
The most common side effects of biologic drugs include injection site reactions, such as redness, itching, rash, swelling, or painful lumps under your skin. You might also experience headaches, fever, chills, nausea, aches and pains, a cough, or a sore throat.
Reactions may differ depending on which medication you take.
Biologics change the way your immune system works, so the biggest risk is a higher susceptibility to infection, Ullman says. A previous tuberculosis or hepatitis B infection may be reactivated when you start on biologic therapy, so it’s important to screen for these conditions before getting started. You may also be at higher risk for more common infections, so it’s important to get vaccinated for the flu and pneumonia according to your doctor’s recommendation. Be sure to tell your doctor about any signs of infection right away, such as fever, fatigue, cough, or flu-like symptoms.
Some biologic drugs are associated with a slightly higher risk you’ll develop a blood cancer called lymphoma. In rare cases, biologics may also cause liver problems, joint pain, or nervous system problems. Talk to your doctor about all these risks before starting on a biologic.
10. Biologics Are Expensive
The “sticker price” of biologic drugs is high.
But if you have health insurance, you’re not likely to pay the full price of any infusion drug or its administration.
Before starting on biologic therapy, make sure you can afford it through either your insurance coverage or your own finances. “In most cases, insurance companies do cover biologics, and most drug companies offer financial assistance programs to help cover the cost,” Ullman says.
Another, less expensive option than biologics are biosimilars, drugs that are nearly identical copies of biologics and contain the same active ingredients. Since scientists can’t make an exact copy of a biologic (a living cell), biosimilars are highly similar to biologics, rendering them bioequivalent.
Remicade (infliximab) has an FDA-approved biosimilar medication called infliximab-dyyb (Inflectra). Humira (adalimumab) has an FDA-approved biosimilar medication called Amjevita (adalimumab-atto).
Additional reporting by Ashley Welch.
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The Pros and Cons of Biologics for Ulcerative Colitis
Over the past 15 years, treatment options for ulcerative colitis (UC) have expanded quite a bit.
Among the newer 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, they 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.
The fact that biologics target the activity of the patient’s own immune system is what sets them apart from some 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..jpg){kind=logo}
The biologics that are now approved by the U.S. Food and Drug Administration (FDA) for treating ulcerative colitis include:
- Humira (adalimumab)
- Simponi (golimumab)
- Remicade (infliximab)
- Entyvio (vedolizumab)
- Stelara (ustekinumab)
Many biologics, including Humira, Simponi, and Remicade, work by targeting a protein called tumor necrosis factor alpha (TNF-alpha), which contributes to inflammation.
Another way that biologics target inflammation is by addressing the problem of too many white blood cells in the GI tract. Entyvio works this way — it blocks these inflammatory cells from getting to the site of inflammation.
A review published in October 2019 in the United European Gastroenterology Journal examined the safety and efficacy of Humira, Simponi, Remicade and Entyvio, and found that all four biologics were effective at treating moderate to severe ulcerative colitis, and all were comparatively safe.
Stelara is the new biologic on the block.
While the drug has been on the market since 2009 for the treatment of Crohn’s disease, psoriatic arthritis, and psoriasis, it was only approved in 2019 for the treatment of ulcerative colitis.
The new approved use for Stelara was based on results of a clinical trial published in September 2019 in the New England Journal of Medicine that found Stelara could safely and effectively induce and maintain remission in adults with moderately to severely active ulcerative colitis.
Stelara works by blocking interleukin-12 and interleukin-23, immune proteins known to be involved in immune responses in inflammatory bowel disease and other immune-mediated conditions.
RELATED: 10 Things to Know About Biologics for Ulcerative Colitis
The Advantages of Biologics for Ulcerative Colitis
Biologics can improve gut symptoms, bringing about and maintaining remission (preventing flares) in people with moderate to severe ulcerative colitis.
They can also reduce the need for hospitalization and surgery, says the British organization Crohn’s & Colitis UK.
One key advantage of biologic therapies over other types of treatment for ulcerative colitis is that their mechanisms of action are more precisely targeted to the factors responsible for the condition, notes the Crohns & Colitis Foundation.
Unlike corticosteroids, for example, which affect the whole body and may produce major side effects, biologic agents act more selectively. These therapies are targeted to particular proteins that have already been proven to be involved in ulcerative colitis.
“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.
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The Potential Downsides of Biologics
While biologics may be a promising option for treating your ulcerative colitis, not every drug is suited to every patient.
“We will work with patients for a while to tailor a treatment plan that is right for them,” says Dr. Raffals. “That may mean trying different biologics and small-molecule drugs, and, of course, taking into account what the patient’s insurance will cover.”
A person’s lifestyle, demographic factors, and the severity of the disease are all considerations in the choice of whether or not to use biologics, and which of them 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 new drugs, so — with the exception of Remicade (infliximab) — long-term safety information is not available.
- 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 has come off patent — has increased competition in the biologics market and is helping 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, can be self-administered via an at-home injection, while others, like Entyvio, require intravenous infusion. 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: soreness at the injection site, aches and pains, fever, and increased susceptibility to infection.
The introduction of biosimilars — medicines that are very similar to an original biologic therapy that has come off patent — has increased competition in the biologics market and is helping to bring down the cost of this type of therapy.If you’re considering biologics for treatment, speak to your doctor to find out what’s best for you. As Tsynman says, “At the heart of the decision is the relationship between the patient and the physician and specifically exploring what works best for each individual.
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Additional reporting by Jordan M. Davidson.
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