What are biologics for ulcerative colitis. How do biologics work for UC treatment. When are biologics prescribed for ulcerative colitis. What types of biologic drugs are available for UC. How are biologic medications administered for ulcerative colitis. How long do biologics take to work for UC. Can biologics lead to remission in ulcerative colitis.

Understanding Biologic Drugs for Ulcerative Colitis

Biologic drugs have revolutionized the treatment of moderate to severe ulcerative colitis (UC) for patients who don’t respond well to traditional medications. These advanced therapies offer new hope for managing inflammation and achieving remission. But what exactly are biologics, and how do they work for UC?

Biologics are complex medications derived from living organisms. They’re designed to target specific components of the immune system involved in the inflammatory process that drives ulcerative colitis. By precisely interfering with these pathways, biologics can reduce intestinal inflammation and alleviate UC symptoms more effectively than conventional drugs in many cases.

Key Biologic Medications for UC

• Humira (adalimumab)
• Simponi (golimumab)
• Remicade (infliximab)
• Entyvio (vedolizumab)
• Stelara (ustekinumab)

Each of these medications works slightly differently, but all aim to control the overactive immune response in the intestines that characterizes ulcerative colitis. Understanding the unique aspects of biologic therapy can help patients make informed decisions about their UC treatment.

When Are Biologics Prescribed for Ulcerative Colitis?

Contrary to what some might assume, biologic drugs are not typically the first line of treatment for ulcerative colitis. So when do doctors consider prescribing biologics for UC patients?

Biologics are usually recommended when traditional medications like aminosalicylates (5-ASAs) or immunomodulators have failed to control symptoms or cause intolerable side effects. Dr. Thomas Ullman, chief of gastroenterology at Albert Einstein College of Medicine, explains: “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.”

However, treatment approaches are evolving. Some gastroenterologists now advocate for earlier use of biologics in certain cases, particularly when UC is severe or rapidly progressing. The decision to start biologic therapy often depends on factors such as:

• The severity of UC symptoms
• The extent of intestinal inflammation
• Previous response to other treatments
• The patient’s overall health status
• The doctor’s clinical experience and judgment

Ultimately, the timing of biologic therapy is a personalized decision made between the patient and their healthcare provider, considering the individual course of the disease and treatment goals.

How Biologic Drugs Target Ulcerative Colitis

One of the key advantages of biologic drugs is their targeted approach to treating ulcerative colitis. Unlike some traditional medications that have broad effects on the immune system, biologics are designed to interfere with specific steps in the inflammatory process. But how exactly do these medications work?

Biologic drugs for UC can be categorized based on their mechanism of action:

Anti-TNF Drugs (TNF Inhibitors)

Medications like Humira, Simponi, and Remicade belong to this group. They work by blocking tumor necrosis factor alpha (TNF-alpha), a protein that promotes inflammation in the intestines and other organs. By neutralizing TNF-alpha, these drugs can significantly reduce intestinal inflammation in many UC patients.

Integrin Receptor Antagonists

Entyvio falls into this category. It works by blocking a specific protein on the surface of inflammatory cells, preventing them from moving out of blood vessels and into intestinal tissue. This targeted approach can help reduce inflammation while potentially having fewer systemic effects.

Interleukin Inhibitors

Stelara, the newest biologic approved for UC, blocks interleukin-12 and interleukin-23. These proteins play a crucial role in the immune responses associated with inflammatory bowel diseases like ulcerative colitis. By interfering with these signaling molecules, Stelara can help modulate the immune response and reduce inflammation.

The targeted nature of biologics not only makes them effective for many patients but also contributes to their potential for fewer side effects compared to broad-spectrum immunosuppressants. However, it’s important to note that the effectiveness of each biologic can vary from person to person.

Administration Methods for Biologic Medications in UC Treatment

Understanding how biologic drugs are administered is crucial for patients considering or starting this type of therapy. The method of administration can impact treatment adherence, convenience, and even effectiveness. So, how are biologic medications given to UC patients?

Biologic drugs for ulcerative colitis are typically administered in one of two ways:

1. Subcutaneous Injections

Some biologics are available as injectable medications that can be administered at home. These include:

• Humira (adalimumab)
• Simponi (golimumab)
• Stelara (ustekinumab) – after initial IV dose

The frequency of injections can vary from several times a month to once every three months, depending on the specific medication and treatment phase. Many patients or their caregivers can learn to administer these injections at home after proper training, offering greater flexibility and convenience.

2. Intravenous (IV) Infusions

Other biologics require intravenous infusion, which is typically done in a healthcare setting. These include:

• Remicade (infliximab)
• Entyvio (vedolizumab)

IV infusions are usually given every eight weeks after an initial loading phase with more frequent doses. The duration of each infusion can vary from about 30 minutes to 2-4 hours, depending on the specific medication.

The choice between injectable and infusion biologics often depends on factors such as the patient’s preference, lifestyle, insurance coverage, and the specific characteristics of their UC. Some patients prefer the convenience of at-home injections, while others feel more comfortable with infusions administered by healthcare professionals.

Combining Biologics with Other UC Treatments

When it comes to managing ulcerative colitis with biologics, one common question is whether these medications can or should be used alongside other treatments. The approach to combining therapies can significantly impact treatment success, so what do experts recommend?

Dr. Ullman notes, “A biologic medication combined with a traditional ulcerative colitis drug may work better than either drug alone.” This combination approach, often referred to as “combination therapy,” can potentially enhance the effectiveness of treatment for some patients.

However, there are important considerations and guidelines to keep in mind:

• Biologics should not be combined with other biologic medications due to an increased risk of complications.
• According to the American College of Gastroenterology (ACG) guidelines, if a patient previously took a 5-ASA medication without success, they shouldn’t continue it when starting an anti-TNF drug like adalimumab or infliximab.
• Some patients may benefit from combining a biologic with an immunomodulator, such as azathioprine or 6-mercaptopurine, but this decision should be made carefully based on individual patient factors.

The optimal treatment strategy often involves a personalized approach, taking into account the patient’s disease severity, previous treatment response, potential side effects, and overall health status. Regular monitoring and open communication between the patient and their healthcare team are crucial to ensure the best possible outcomes when combining therapies.

Timeline for Biologic Effectiveness in UC Management

For patients starting biologic therapy for ulcerative colitis, understanding the timeline for potential improvement is crucial. How long does it typically take for these medications to show effects?

The onset of action for biologic drugs can vary depending on the specific medication and individual patient factors. However, some general timelines can be considered:

• For anti-TNF drugs like Humira, Simponi, or Remicade, it may take up to 8 weeks before patients notice significant improvement in their UC symptoms.
• Some patients may experience more rapid improvement, while others might require a longer time to see noticeable effects.
• The initial response doesn’t always indicate long-term effectiveness, so continued monitoring is essential.

It’s important for patients to maintain their treatment regimen for several weeks, even if they don’t see immediate improvement. Premature discontinuation could lead to missed opportunities for effective treatment. Regular follow-ups with the healthcare provider during this initial period can help assess the response and make any necessary adjustments to the treatment plan.

Navigating Biologic Options in UC Treatment

The world of biologic therapies for ulcerative colitis is diverse, with several options available. But what happens if the first biologic medication doesn’t work as expected? How do doctors approach this situation?

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

1. Dose Optimization: The doctor might suggest increasing the dose or decreasing the interval between doses to improve effectiveness.
2. Switching Biologics: If dose adjustment doesn’t help, switching to a different biologic drug might be recommended. For instance, the ACG guidelines suggest trying Entyvio if anti-TNF therapy isn’t effective.
3. Combination Therapy: In some cases, adding an immunomodulator to the biologic regimen might enhance its effectiveness.

The decision-making process for navigating biologic options is highly individualized. Factors such as the patient’s specific UC characteristics, previous treatment responses, potential side effects, and personal preferences all play a role in determining the best course of action.

It’s worth noting that the field of UC treatment is continually evolving, with new biologics and other advanced therapies in development. Staying informed about these advancements and maintaining open communication with the healthcare team can help ensure that patients have access to the most appropriate and effective treatments for their condition.

Long-Term Outcomes and Considerations with Biologic Therapy

For many patients with ulcerative colitis, biologic therapy offers the potential for long-term disease management and improved quality of life. But what can patients expect in terms of long-term outcomes, and what factors should they consider?

Potential for Remission

One of the primary goals of biologic therapy is to induce and maintain remission in UC. Dr. Ullman notes, “We’re seeing fewer hospital admissions, fewer surgeries, and less disability from ulcerative colitis with the use of these drugs.” Many patients on biologics experience long periods of remission, during which symptoms are minimal or absent, and intestinal inflammation is well-controlled.

Ongoing Treatment Necessity

It’s crucial to understand that biologics are typically long-term maintenance drugs. Once a patient starts biologic therapy and achieves remission, continuing the medication is usually necessary to prevent UC from flaring. Stopping treatment without consulting a doctor can lead to disease relapse.

Potential for Decreased Effectiveness

While biologics can be highly effective, some patients may experience a decrease in response over time. This phenomenon, known as loss of response, can occur months or years after starting treatment. The reasons for this are not entirely clear but may involve the development of antibodies against the drug or changes in the disease itself.

Regular Monitoring

Long-term use of biologics requires ongoing monitoring to assess effectiveness and watch for potential side effects. This typically involves regular check-ups, blood tests, and sometimes colonoscopies to evaluate intestinal healing.

Impact on Overall Health

By effectively controlling UC, biologic therapy can have positive effects on overall health and quality of life. Many patients report improvements in energy levels, work productivity, and ability to engage in daily activities.

While biologic therapy offers significant benefits for many UC patients, it’s important to have realistic expectations and maintain open communication with the healthcare team. Regular follow-ups, adherence to the treatment plan, and prompt reporting of any concerns or changes in symptoms can help ensure the best possible long-term outcomes with biologic therapy.

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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