Tuesday, September 27, 2022

New Biologic Drugs For Ulcerative Colitis

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Check In Check Up: Ulcerative Colitis

Positioning of Biologics and New Therapeutics for Ulcerative Colitis

You dont have to settle for good enough ulcerative colitis care. Take this series of assessments to evaluate how well your treatment is working.

Prednisone, hydrocortisone, and methylprednisolone work by suppressing the entire immune system, rather than targeting inflammation.

Because of their high risk of side effects, these three drugs are typically reserved for moderate to severe ulcerative colitis. They also shouldnt be taken for very long.

Budesonide , on the other hand, is considered a first-line treatment for ulcerative colitis. Budesonide can be taken orally as a tablet or capsule, or rectally, as a foam or tablet or in an enema. Because of the way the body processes budesonide, the oral form causes fewer side effects than other corticosteroids, according to a paper published in August 2016 in Expert Opinion on Pharmacotherapy.

If you take corticosteroids orally or by injection, you may have significant side effects. Local steroids which are applied just to the area that needs treatment are generally the preferred option.

For severe flares of ulcerative colitis, hospitalization and high-dose intravenous corticosteroids are often required. Once remission is achieved, your dose of steroids will be tapered gradually and ultimately stopped. Steroids cant be stopped suddenly because they cause the body to reduce production of the natural steroid cortisol.

Steroids are ineffective as maintenance therapy to keep ulcerative colitis in remission.

Combination Treatment Shows Promise For Ulcerative Colitis

Tremfaya is a combination of guselkumab and golimumab.

A combination of 2 drugsone for ulcerative colitis and one for plaque psoriasisis showing promise as a new treatment for moderate to severely active UC.

According to Janssen,1 results of a in a phase 2a clinical trial have shown that guselkumab , a combination of a monoclonal antibody against IL-23 used to treat plaque psoriasis and golimumab , a tumor necrosis factor-alpha antagonist, induced higher rates of clinical response, clinical remission, endoscopic improvement, and a composite histologic-endoscopic endpoint at 12 weeks than either treatment alone in patients with UC.

Although guselkumab, along with combination guselkumab and golimumab, are not currently approved for the treatment of adults with UC in the United States, the combined treatment shows incredible promise, Jan Wehkamp, MD, PhD, disease area leader in Gastroenterology for Janssen Research & Development told Drug Topics®.

It is significant because, while there are patients living with UC who have responded to their current therapies, there are still many other patients, such as refractory patients, who have failed or lost response to current advanced therapies. Combination therapy represents an exciting and important opportunity to leverage our pathway strategy and scientific expertise to bring forth new treatment options that can address the unmet needs of patients living with UC, Wehkamp added.

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What Is Ulcerative Colitis

Ulcerative colitis is essentially a type of inflammatory bowel disease . The term inflammatory bowel disease generally refers to one of several chronic diseases that affect the gastrointestinal tract, the system of organs from the mouth to the anus that is responsible for ingesting food, extracting nutrients, and disposing of waste materials.

Ulcerative colitis is one of the more common IBDs, but microscopic colitis and Crohns disease are also fairly common examples in the category . They all share some common symptoms, but they each have specific characteristics that set them apart.

Ulcerative colitis is focused on and limited to the large intestinealso known as the colon. The key characteristics that set it apart from Crohns disease is the irritation, swelling, and sores on the inner lining of the colon. Crohns disease, by comparison, can affect other parts of the gastrointestinal tract such as the small intestine, and it can be limited to certain areas. Ulcerative colitis is a more broad inflammation of the inner lining of the entire colon.

One of the other main characteristics of ulcerative colitis is that it is chronic. When doctors refer to a condition as chronic, they are referring to something that is long-lasting or persistent. For many sufferers of ulcerative colitis , the symptoms tend to recur, and there is currently no known cure. The best hope is a long term remission.

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The Advantages Of Biologics For Ulcerative Colitis

Biologics can improve gut symptoms, bringing about and maintaining remission 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 theyre not as scared about taking a corticosteroid, and thats 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.

These Are Their Stories:

Biologics and UC: Your Top Questions Answered

Suzy

I am completely blown away by my results! Evinature helped improved my quality of life. I am forever grateful and astonished at my results!

Sonya

A month in, I felt better. At two months, my blood tests were great, and at six months, I entered clinical and endoscopic remission. Now I rely solely on herbal treatment.

Almog

I was completely shocked that a plant had much stronger effects than very high dosages of steroids and very powerful medications. I started feeling much better!

Bosmat

The treatment exceeded all my expectations. I went back to living fully. And all this without any conventional medicine. Today, a year later, Im still in remission.

Shahar

It helped within 48 hours to subdue my flare up. Took about 2 more weeks to have complete remission. Treated with this for the last 7 years with great success.

Yael

On Sunday I started your natural treatment. On Monday morning, the bleeding stopped and everything looked normal. It acted like magic. Thank you!

Tomer

It allowed me to return to my normal activities. I gained weight, was more productive with my job, no longer depressed because my symptoms were down. I really recommend it, its really helpful.

Tamar

The change started from the first week. I recommend anyone with colitis to try it. I returned to function normally, and returned to the mother my children had known.

Tal

Inon

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Biologics Arent Considered A First

Although many doctors believe its better to start a biologic drug sooner rather than later, its not likely to be your first ulcerative colitis treatment. The current indications for biologics in ulcerative colitis are for people who havent responded to traditional medications or are dependent on corticosteroids to relieve their symptoms, says Thomas Ullman, MD, chief of the division of gastroenterology at the Albert Einstein College of Medicine in New York City.

Its 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 doctors personal judgment and experience.

What Differences Might There Be

Biosimilars are thoroughly tested. They meet strict standards to show they are as safe, effective and have no clinically meaningful differences from the originator. Where NICE has recommended the use of a biological medicine, they state that the same guidance applies to the biosimilar.However, there are likely to be some small differences including:

  • Injection device: Injection devices for all the different products vary. If you have changed brand, this is likely to be different from the one you have been used to using. You will receive full training until you are confident to use the new one.
  • Homecare delivery service: If you change to a different product, you are likely to have this delivered by a different homecare delivery service.
  • Side effects: Because the formulations are not the same, some people who switch products may experience new injection site reactions. Your IBD team can help you with tips to reduce these.
  • Some people may be sensitive to latex, which is used as a needle cover in some of some types of biosimilars, or citrate which is sometimes included as one of the ingredients.Some types of adalimumab are available without citrate or latex, and you can ask to try one of these.

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    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 shouldnt be taken together because of an increased risk of complications.

    Current guidelines also state that if you previously took a 5-ASA that wasnt successful, you shouldnt keep taking it if you move on to an anti-TNF drug, such as adalimumab or infliximab.

    The Zeposia 360 Supporttm Program Can Help You Every Step Of The Way

    Treating IBD: Biologics

    Have questions about ZEPOSIA or starting treatment? With ZEPOSIA 360 Support, a UC Nurse Navigator is there to make sure you have all the answers you need when it comes to ZEPOSIA. A dedicated UC Nurse Navigator can also help with insurance benefits, financial support, and so much more, including determining if youre eligible for the ZEPOSIA $0 co-pay offer.**

    **Depending on insurance coverage, patients may be eligible to receive a prescription benefit offer for out-of-pocket drug costs and pay as little as $0 per prescription. Maximum savings limit applies patient out-of-pocket expenses may vary. This program is not health insurance. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state health care programs. Please for Program Terms, Conditions, and Eligibility Criteria.

    Wondering if ZEPOSIA is right for you? Here are 3 things you can do to get started:

    • Connect with your healthcare provider. Here are some questions to get the conversation started
    • Visit ZEPOSIA.com to learn more about ZEPOSIA and the ZEPOSIA 360 Support program
    • Connect with a UC Nurse Navigator by calling , Monday to Friday, 8 AM 8 PM ET

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    What Makes Cura Different From Other Forms Of Curcumin

    Unlike any available Curcumin on the market, we specifically use a non-absorbable formulation that reduces systemic exposure and increases curcumin concentration where its most needed: in the gut!

    The formulation is designed to directly target and soothe inflammation in the intestinal mucosa, where IBD inflammation occurs. Our studies show this treatment to be highly effective for treating mild-to-moderate Ulcerative colitis.

    Work Closely With Your Doctor

    If your doctor prescribes a biologic, theyâll want to see you often to make sure the treatment works safely and effectively. So be sure to go to all of your appointments.

    Tell your doctor about all prescription and over-the-counter drugs, supplements, or natural remedies you take. Any of those can affect the way other medications or supplements work. Talk to your doctor before you take anything new. Also tell your doctor about all of your medical conditions. Let them know if your symptoms get worse or if you notice any new ones.

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    Comparison With Acg Guidelines

    Unlike the updated American College of Gastroenterology ulcerative colitis guidelines released in 2019, as reported by Medscape Medical News, the AGA clinical practice guidelines are not intended to cover all aspects of UC. Rather, explains Feuerstein, “the guidelines are focused on providing the most thorough evidence-based answers to specific PICO questions based only on the GRADE assessment of the evidence.”

    The ACG guidelines, on the other hand, include recommendations for the diagnosis, medical management of the disease at all levels of severity, and quality of life, according to David T. Rubin, MD, FACG, from the University of Chicago, Illinois, who was lead author on the ACG guidelines. The two guidelines overlap around the use of biologic therapies and the choice of severity-based maintenance therapies in patients with moderate to severe disease to reduce the likelihood of future complications, he told Medscape Medical News. And although the ACG guidance does not specifically recommend early use of biologic agents over gradual step up after failure of 5-ASA therapy, Rubin acknowledges that “large gaps in care with 5-ASA therapies indicate a clear need for better therapies.”

    Gastroenterology. Published online January 13, 2020. Full text

    A New Indication Of Success: Fda Approves Ozanimod For Ulcerative Colitis

    Biologics for Treatment of Ulcerative Colitis

    The novel drug created at Scripps Research has achieved a second FDA approval, this time for ulcerative colitis, as clinical trials continue for Crohns disease.

    May 27, 2021

    LA JOLLA, CAOzanimod, the drug invented at Scripps Research that won FDA approval last year for relapsing forms of multiple sclerosis, has been approved in the United States for a second high-need medical condition, ulcerative colitis.

    The once-daily oral drug, sold by Bristol Myers Squibb under the name Zeposia, can now be prescribed to treat adults with moderate to severe forms of the inflammatory bowel disease. Notably, its the first drug in a novel class of immune-modulating compounds to be approved for ulcerative colitis, which affects about 1 million people in the United States.

    For patients with ulcerative colitis, this oral drug offers a better and more convenient option to control disease progression and improve quality of life, says Hugh Rosen, MD, PhD, who invented ozanimod along with fellow Scripps Research professor Edward Roberts, PhD, and their laboratory colleagues. The hope is that this will lead to fewer dangerous complications or serious infections than current treatment options, providing a steadier path for newly diagnosed patients as well as those failing other treatments.

    Additional molecules developed by Rosen and Roberts at Scripps Research are currently in phase 2 clinical trials for major depressive disease and anxiety, and phase 1 studies for treatment of autism.

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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 patients insurance will cover.

    A persons 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:

    If youre considering biologics for treatment, speak to your doctor to find out whats 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.

    Routine Tests To Get Started

    You can start treatment after taking 2 routine tests that can help make sure ZEPOSIA is right for you. If you have a history of certain eye conditions , you may also need an eye exam.

    If youve had some of these tests within the last 6 months, let your healthcare provider knowthey may not need to be repeated.

    Your UC Nurse Navigator or healthcare provider will help schedule these routine tests. For eligible patients, they may all be completed with an in-home visit:*

    • An electrocardiogram a common test that uses small sensors to monitor your heart and makes sure its working normally before you start treatment.

    • Blood workincluding complete blood count and liver function tests.

    • The ZEPOSIA Prescribing Information does not require ongoing lab monitoring unless indicated by your healthcare provider.

    Once I was prescribed ZEPOSIA, a clinician from ZEPOSIA 360 Support was sent to my house to do all the necessary tests.*

    Trey

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    The Future Of Biosimilars

    As of December 2019, a total of 26 biosimilars have been approved in the United States. But that number could grow quickly, according to Anita Afzali, MD, a gastroenterologist and the medical director of The Ohio State University Inflammatory Bowel Disease Center in Columbus.

    There are more than 650 biosimilars under development, Dr. Afzali notes, adding that most are in the early stages of development. Whats to come in the United States will certainly be a hot topic of discussion.

    So far in the United States, biosimilars for IBD have been approved for all the same uses as their originator drugs but have not been ruled interchangeable with those drugs. In practice, this means that pharmacists cant substitute a biosimilar for a biologic, as they could with a generic for a brand-name drug.

    Afzali worries that this may become a distinction without a difference. Its easy to imagine, she says, that an insurance company or hospital system could simply cover only the biosimilar equivalent of an original biologic. In this imagined scenario, she says, the state or the insurance or the pharmacist is saying, You have to try the biosimilar, even when a person has already experienced side effects from the biologic that might become worse with the biosimilar.

    Treatment Loses Effect Over Time

    Ulcerative colitis – causes, symptoms, diagnosis, treatment, pathology

    Some people find treatment is effective to begin with, but this becomes less over time. This often happens because the immune system recognises the drug as a foreign substance and thinks it is harmful. It then produces proteins called antibodies against the biologic drug and these stop it from working as well.If this happens there may be a few options:

  • Increase the dose.

  • Add an immunosuppressant so that you would be taking a combination of medicines. There is evidence that this can reduce the levels of antibodies.

  • Change to a biologic that works in a different way.

  • Change to a different biologic that works in the same way.

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