What are biologics for ulcerative colitis. How do biologics work for UC treatment. When are biologics prescribed for ulcerative colitis. What are the different types of biologics for UC. How are biologic medications administered for ulcerative colitis. Can biologics be combined with other UC treatments. How long does it take for biologics to work for ulcerative colitis. What if a biologic doesn’t work for my UC. How effective are biologics in achieving UC remission. Do biologics for ulcerative colitis lose effectiveness over time.

Understanding Biologics as a Treatment Option for Ulcerative Colitis

Biologics have emerged as a powerful treatment option for individuals with moderate to severe ulcerative colitis (UC) who haven’t responded well to traditional medications. These innovative drugs are designed to target specific inflammatory processes in the body, offering hope for those struggling to manage their UC symptoms. But what exactly are biologics, and how do they work in treating ulcerative colitis?

Biologics are complex medications derived from living organisms. Unlike conventional drugs that are chemically synthesized, biologics are created using biotechnology methods. They are engineered to interact with specific proteins or cells in the body that are involved in the inflammatory process associated with UC.

The Role of Biologics in UC Treatment

Biologics play a crucial role in managing ulcerative colitis by targeting and suppressing specific components of the immune system that contribute to inflammation in the colon. By doing so, they can help reduce symptoms, promote healing of the intestinal lining, and potentially lead to long-term remission.

Are biologics considered a first-line treatment for UC? Generally, biologics are not the initial treatment option for most patients with ulcerative colitis. They are typically prescribed when other treatments, such as aminosalicylates (5-ASAs) or immunomodulators, have proven ineffective or caused intolerable side effects. However, in some cases of severe UC, doctors may recommend starting biologic therapy earlier in the treatment process.

Types of Biologics Used in Ulcerative Colitis Treatment

Several types of biologics are approved for the treatment of ulcerative colitis. Each type targets different aspects of the inflammatory process. Understanding the different classes of biologics can help patients and healthcare providers make informed decisions about treatment options.

Anti-TNF Drugs

Anti-TNF drugs, also known as TNF inhibitors, are a widely used class of biologics for UC. These medications work by blocking tumor necrosis factor alpha (TNF alpha), a protein that promotes inflammation in the intestines and other organs. Examples of anti-TNF drugs used in UC treatment include:

• Humira (adalimumab)
• Simponi (golimumab)
• Remicade (infliximab)

Integrin Receptor Antagonists

Another type of biologic used in UC treatment is the integrin receptor antagonist. These drugs work by blocking specific proteins on the surface of inflammatory cells, preventing them from moving out of blood vessels and into intestinal tissues. The primary example of this class is:

• Entyvio (vedolizumab)

Interleukin Inhibitors

The newest class of biologics approved for UC treatment is interleukin inhibitors. These drugs target specific interleukin proteins involved in the immune response associated with inflammatory bowel diseases. The main example in this category is:

• Stelara (ustekinumab)

How do these different types of biologics compare in effectiveness? While all approved biologics have shown efficacy in treating UC, individual responses can vary. Some patients may respond better to one type of biologic than another, and your doctor will work with you to find the most effective option for your specific case.

Administration of Biologic Medications for Ulcerative Colitis

Understanding how biologic medications are administered is crucial for patients considering or starting this treatment. The method of administration can impact treatment adherence and overall patient experience.

Injectable Biologics

Some biologic medications are available as subcutaneous injections. These can be administered at home by the patient or a caregiver after proper training. The frequency of injections can vary:

• Some may require injections several times a month
• Others might be administered once every few months
• Initial “starter” doses are often more frequent

Intravenous (IV) Infusions

Other biologics require intravenous infusion, which is typically done in a healthcare setting. The infusion schedule for these medications usually involves:

• More frequent initial infusions
• Maintenance infusions every eight weeks
• Infusion times ranging from 30 minutes to 2-4 hours, depending on the specific drug

Is the administration method a factor in choosing a biologic? The choice between injectable and infusion biologics often depends on factors such as patient preference, lifestyle considerations, and the specific characteristics of each medication. Your healthcare provider will discuss these options with you to determine the most suitable approach for your treatment.

Combining Biologics with Other UC Treatments

In many cases, biologic therapy is not used in isolation but as part of a comprehensive treatment plan for ulcerative colitis. Understanding how biologics can be combined with other medications is essential for optimizing treatment outcomes.

Combination Therapy Approaches

Combining a biologic with a traditional UC medication may enhance treatment efficacy. However, it’s important to note that not all combinations are recommended or safe. Here are some key points about combination therapy:

• Biologics may be used alongside immunomodulators in some cases
• Combining two different biologics is generally not recommended due to increased risk of complications
• If a 5-ASA medication was previously ineffective, it’s typically discontinued when starting an anti-TNF biologic

How does combination therapy affect treatment outcomes? Some studies suggest that combining certain biologics with immunomodulators can lead to better outcomes and reduced risk of developing antibodies against the biologic. However, the decision to use combination therapy should be made on an individual basis, considering the potential benefits and risks for each patient.

Timeline and Expectations for Biologic Treatment Effectiveness

When starting biologic therapy for ulcerative colitis, it’s important to have realistic expectations about when you might start seeing improvements in your symptoms. The timeline for effectiveness can vary depending on the specific medication and individual patient factors.

Initial Response Time

For many patients starting anti-TNF drugs, it may take up to eight weeks before noticeable improvements in UC symptoms occur. However, the response time can vary:

• Some patients may experience rapid improvement within days or weeks
• Others might require several weeks before noticing significant changes
• In some cases, it may take up to 12-16 weeks to determine if the treatment is effective

What should patients do if they don’t see immediate improvements? It’s crucial to continue the prescribed treatment regimen for several weeks, even if symptoms don’t improve immediately. Prematurely discontinuing treatment may prevent you from experiencing the full benefits of the medication. Always consult with your healthcare provider before making any changes to your treatment plan.

Navigating Treatment Changes and Alternatives

While biologics can be highly effective for many patients with ulcerative colitis, they may not work for everyone. In some cases, patients may need to try different biologics or adjust their treatment approach to achieve optimal results.

Strategies for Optimizing Biologic Therapy

If a patient doesn’t respond adequately to their initial biologic treatment, several strategies can be considered:

• Dose escalation: Increasing the dose of the current biologic
• Interval adjustment: Decreasing the time between doses
• Switching biologics: Trying a different biologic medication, possibly from a different class

How do doctors determine when to switch biologics? The decision to switch biologics is based on several factors, including the patient’s response to the current treatment, side effects, and overall disease activity. Guidelines from the American College of Gastroenterology suggest that if anti-TNF therapy isn’t effective, switching to a medication like Entyvio (vedolizumab) may be beneficial.

Personalized Treatment Approaches

It’s important to recognize that ulcerative colitis treatment is highly individualized. What works for one patient may not be effective for another. Your healthcare provider will work closely with you to find the most effective treatment plan, which may involve trying different biologics or combination therapies.

Long-Term Outcomes and Remission with Biologic Therapy

One of the primary goals of biologic therapy in ulcerative colitis is to achieve and maintain long-term remission. Understanding the potential for remission and the long-term effects of biologic treatment is crucial for patients and healthcare providers alike.

Potential for Long-Term Remission

Biologic therapies have shown significant promise in helping patients with UC achieve and maintain remission. Some key points about remission with biologics include:

• Many patients experience long periods of symptom-free remission
• Biologics can reduce the need for hospitalizations and surgeries related to UC
• Long-term use of biologics may help prevent disability associated with ulcerative colitis

Can patients stop taking biologics once they achieve remission? Generally, biologic therapy is considered a long-term maintenance treatment. Stopping treatment without consulting your doctor can lead to disease flares. The decision to discontinue or adjust biologic therapy should always be made in consultation with your healthcare provider, taking into account your individual disease history and current health status.

Monitoring Long-Term Effectiveness

While biologics can be highly effective, their effectiveness may change over time for some patients. This phenomenon, known as loss of response, can occur for various reasons:

• Development of antibodies against the biologic
• Changes in the patient’s immune system or disease characteristics
• Individual variations in drug metabolism or clearance

How can the long-term effectiveness of biologics be maintained? Regular monitoring, including clinical assessments and sometimes blood tests or endoscopies, can help detect any decrease in treatment effectiveness early. If a loss of response is detected, your doctor may recommend strategies such as dose adjustments, adding an immunomodulator, or switching to a different biologic to maintain disease control.

Safety Considerations and Potential Side Effects of Biologic Therapy

While biologics have revolutionized the treatment of ulcerative colitis, like all medications, they come with potential risks and side effects. Understanding these risks is crucial for patients and healthcare providers to make informed decisions about treatment.

Common Side Effects

The side effects of biologics can vary depending on the specific medication, but some common ones include:

• Injection site reactions (for injectable biologics)
• Infusion reactions (for IV biologics)
• Increased risk of infections
• Headache
• Fatigue
• Nausea

Serious Potential Risks

While less common, some more serious potential risks associated with biologic therapy include:

• Serious infections, including tuberculosis reactivation
• Increased risk of certain types of cancer (though the overall risk remains low)
• Liver problems
• Allergic reactions

How can patients minimize the risks associated with biologic therapy? Proper screening before starting treatment, regular monitoring during therapy, and open communication with your healthcare provider about any new symptoms or concerns are crucial. Additionally, following recommended vaccination schedules and maintaining overall health can help reduce risks.

Balancing Benefits and Risks

When considering biologic therapy, it’s important to weigh the potential benefits against the risks. For many patients with moderate to severe ulcerative colitis, the benefits of improved symptom control and quality of life outweigh the potential risks. Your healthcare provider will help you assess your individual risk-benefit profile to make the best treatment decision.

In conclusion, biologics represent a significant advancement in the treatment of ulcerative colitis, offering hope for many patients who have not found relief with traditional therapies. While they are not without risks and may not be effective for everyone, biologics have the potential to dramatically improve quality of life and disease outcomes for many individuals with UC. As research continues and new biologics are developed, the options for UC treatment continue to expand, providing more opportunities for personalized and effective care.

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.

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. ”

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.

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. ”

Additional reporting by Jordan M. Davidson.

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