What are biologics for ulcerative colitis. How do biologics work in treating UC. When are biologics prescribed for ulcerative colitis. What types of biologic medications are available for UC. How are biologic drugs administered for ulcerative colitis. Can biologics be combined with other UC treatments. How long does it take for biologics to show effects in UC patients.

Understanding Biologic Treatments for Ulcerative Colitis

Biologic drugs have revolutionized the treatment landscape for ulcerative colitis (UC), offering hope to patients with moderate to severe cases who haven’t responded well to traditional medications. These advanced therapies target specific inflammatory processes in the body, providing a more focused approach to managing UC symptoms and potentially inducing long-term remission.

Are biologics considered a first-line treatment for UC? Typically, biologics are not the initial treatment option for ulcerative colitis patients. Doctors usually prescribe them when traditional medications like aminosalicylates (5-ASAs) or immunomodulators prove ineffective or cause intolerable side effects. However, in cases of severe UC, physicians may opt to start biologic therapy earlier in the treatment course.

The Mechanism of Action: How Biologics Target Inflammation

Unlike conventional UC medications that have broad effects on the immune system, biologics are designed to intervene at specific points in the inflammatory cascade. This targeted approach can lead to more effective symptom control with potentially fewer systemic side effects.

Types of Biologic Drugs for Ulcerative Colitis

• Anti-TNF drugs (TNF inhibitors): These include Humira (adalimumab), Simponi (golimumab), and Remicade (infliximab). They work by blocking tumor necrosis factor alpha (TNF alpha), a protein that promotes inflammation in the intestines and other organs.
• Integrin receptor antagonists: Entyvio (vedolizumab) belongs to this category. It blocks a protein on cell surfaces that allows inflammatory cells to move from blood vessels into intestinal tissue.
• Interleukin inhibitors: Stelara (ustekinumab) is the newest biologic approved for UC. It targets interleukin-12 and interleukin-23, proteins involved in the immune responses associated with inflammatory bowel diseases.

How do these different types of biologics compare in effectiveness? While all approved biologics have shown efficacy in clinical trials, individual patient responses can vary. Your gastroenterologist will consider factors such as disease severity, potential side effects, and your overall health when recommending a specific biologic.

Administration Methods for Biologic Medications

Biologic drugs for ulcerative colitis are administered through injection or infusion, depending on the specific medication. This method of delivery allows the drugs to bypass the digestive system, ensuring that they reach their intended targets in the body.

Injection vs. Infusion: What’s the Difference?

1. Subcutaneous injections: Some biologics, like Humira and Simponi, are given as shots that can be administered at home. The frequency ranges from several times a month to once every three months, with initial doses often being more frequent.
2. Intravenous (IV) infusions: Other biologics, such as Remicade and Entyvio, require IV infusion in a healthcare setting. After initial loading doses, these infusions typically occur every eight weeks and can last anywhere from 30 minutes to several hours.

Can patients learn to self-administer biologic injections? Yes, many patients or their caregivers can be trained to give subcutaneous injections at home, which offers greater convenience and flexibility in treatment schedules.

Combining Biologics with Other UC Treatments

In some cases, combining a biologic with a traditional ulcerative colitis medication may provide better results than either drug alone. However, it’s crucial to note that using two different biologics simultaneously is not recommended due to an increased risk of complications.

Should patients continue taking 5-ASAs when starting a biologic? According to current guidelines from the American College of Gastroenterology (ACG), if a 5-ASA medication was previously ineffective, it should be discontinued when initiating an anti-TNF drug like adalimumab or infliximab.

Timeline for Biologic Efficacy in Ulcerative Colitis

Patients starting biologic therapy should be aware that these medications may not provide immediate relief. It can take up to eight weeks before noticeable improvements in UC symptoms occur, particularly with anti-TNF drugs.

Why is there a delay in the onset of action for biologics? The time lag is often due to the complex nature of the inflammatory processes in UC and the time it takes for the biologic to effectively modulate the immune response. Some patients may experience rapid improvement, while others require more time to see benefits.

Navigating Treatment Options: Switching Between Biologics

If one biologic proves ineffective, there are several strategies that your doctor may consider:

• Dose optimization: Increasing the dose or decreasing the interval between doses of the current biologic.
• Switching to a different biologic: This may involve changing to a drug with a different mechanism of action.
• Trying a new class: For example, if anti-TNF therapy is unsuccessful, guidelines suggest considering Entyvio as an alternative.

How do doctors determine when to switch biologics? This decision is based on various factors, including the patient’s response to the current treatment, the presence of anti-drug antibodies, and the individual’s overall health status. Regular monitoring and open communication with your healthcare provider are essential in making these decisions.

Long-Term Benefits and Remission with Biologic Therapy

Biologic medications have shown remarkable efficacy in reducing chronic inflammation associated with ulcerative colitis. Many patients experience extended periods of remission, leading to fewer hospitalizations, reduced need for surgeries, and improved quality of life.

Is it safe to stop biologic therapy once remission is achieved? Generally, biologic drugs are considered long-term maintenance therapies. Discontinuing treatment without medical supervision can lead to disease flares. Always consult with your gastroenterologist before making any changes to your treatment regimen.

Challenges in Long-Term Biologic Use: Loss of Response

While biologics can be highly effective, some patients may experience a diminished response over time. This phenomenon, known as loss of response, can occur months or years after initially successful treatment.

Factors Contributing to Loss of Response

• Development of anti-drug antibodies
• Changes in the patient’s immune system
• Alterations in drug metabolism
• Progression of the underlying disease

How can loss of response be managed? Strategies may include dose intensification, adding an immunomodulator, or switching to a different biologic. Regular monitoring of drug levels and antibodies can help identify loss of response early and guide treatment adjustments.

Safety Considerations and Potential Side Effects of Biologics

While biologics have transformed UC treatment, they do come with potential risks and side effects that patients should be aware of:

Common Side Effects

• Injection site reactions
• Infusion-related reactions
• Increased risk of infections
• Headaches
• Fatigue

Rare but Serious Concerns

• Reactivation of latent tuberculosis
• Increased risk of certain cancers
• Neurological complications
• Liver problems

How can patients minimize the risks associated with biologic therapy? Regular check-ups, adherence to prescribed screening tests, and prompt reporting of any new symptoms to your healthcare provider are crucial. Additionally, staying up-to-date with vaccinations can help protect against preventable infections.

The Future of Biologic Therapy in Ulcerative Colitis Treatment

As research in the field of inflammatory bowel diseases continues to advance, new biologic therapies and treatment strategies are emerging. These developments aim to provide more personalized and effective options for UC patients.

Emerging Trends in Biologic Research

• Development of biosimilars to increase treatment accessibility
• Exploration of new molecular targets for more precise therapy
• Combination therapies to enhance efficacy and reduce side effects
• Predictive biomarkers to guide treatment selection

What role will personalized medicine play in the future of UC treatment? Advances in genetic testing and biomarker identification may allow for more tailored treatment approaches, potentially improving outcomes and reducing the trial-and-error process in finding effective therapies.

Making Informed Decisions: Partnering with Your Healthcare Team

Navigating the complex landscape of biologic therapies for ulcerative colitis requires a strong partnership between patients and their healthcare providers. Open communication, regular follow-ups, and shared decision-making are key to optimizing treatment outcomes.

Questions to Ask Your Doctor About Biologic Therapy

• Which biologic is most appropriate for my specific case of UC?
• What are the potential benefits and risks of this treatment?
• How will we monitor the effectiveness of the biologic?
• What should I do if I experience side effects?
• Are there any lifestyle modifications I should make while on this therapy?

How often should patients on biologic therapy follow up with their gastroenterologist? The frequency of follow-up visits may vary depending on the individual’s response to treatment and overall health status. Typically, patients should expect regular check-ins, which may include blood tests, colonoscopies, and discussions about symptom management.

Living Well with UC: Complementary Approaches to Biologic Therapy

While biologics play a crucial role in managing moderate to severe ulcerative colitis, a holistic approach to treatment can enhance overall well-being and potentially improve treatment outcomes.

Lifestyle Factors That Support UC Management

• Dietary modifications: Identifying and avoiding trigger foods
• Stress management techniques: Meditation, yoga, or counseling
• Regular exercise: Tailored to individual capabilities and preferences
• Adequate sleep: Prioritizing rest and recovery
• Smoking cessation: For those who use tobacco products

Can complementary therapies enhance the effectiveness of biologics? While not a replacement for prescribed treatments, some patients find that complementary approaches like acupuncture, probiotics, or herbal supplements may help manage symptoms. Always consult with your healthcare provider before starting any new therapies to ensure they don’t interfere with your biologic treatment.

Patient Support and Resources for Those on Biologic Therapy

Embarking on biologic therapy for ulcerative colitis can be a significant life change. Fortunately, numerous resources are available to support patients throughout their treatment journey.

Valuable Resources for UC Patients

• Patient advocacy groups: Organizations like the Crohn’s & Colitis Foundation offer education, support, and community connections.
• Online support forums: Platforms where patients can share experiences and advice.
• Financial assistance programs: Many pharmaceutical companies offer programs to help with the cost of biologic medications.
• Nurse educator services: Some biologic manufacturers provide nurse support to assist with injection training and ongoing care.

How can patients connect with others who are undergoing similar treatments? Support groups, both in-person and online, can provide valuable peer support. Your healthcare provider or local hospital may be able to recommend UC-specific support groups in your area.

In conclusion, biologic therapies have significantly advanced the treatment of ulcerative colitis, offering new hope for patients with moderate to severe disease. While these medications come with considerations and potential risks, they have the potential to dramatically improve quality of life and disease outcomes for many individuals living with UC. As research continues to progress, the future holds promise for even more targeted and effective treatments. By working closely with their healthcare team and staying informed about their options, patients can make empowered decisions about their UC management and strive for long-term remission and improved well-being.

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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