Tuesday, February 7, 2023

New Biologics For Ulcerative Colitis

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What Are Biologics For Ulcerative Colitis

Understanding Treatment Options in IBD

Biologics are medications that doctors use to treat chronic inflammatory conditions such as inflammatory bowel disease . Ulcerative colitis is one type of IBD.

These laboratory-made antibodies are targeted to block specific proteins responsible for the inflammation that drives ulcerative colitis. This makes biologics different from medications such as corticosteroids, which may cause more severe side effects.

The Food and Drug Administration has approved the following biologics to treat moderate-to-severe ulcerative colitis:

  • anti-tumor necrosis factor agents, including:
  • vedolizumab , which is an integrin receptor antagonist that blocks a specific type of receptor present in the gut
  • ustekinumab , which is an interleukin-12 and interleukin-23 antagonist
  • The FDA approved the biosimilars of infliximab and adalimumab. As their name suggests, biosimilars are very similar to the originally approved biologics but may be more cost effective.

    A person may receive biologics as an injection, as an infusion through an intravenous line, or by mouth.

    The method of use, dosage, and frequency varies from one type of biologic to another.

    Doctors typically prescribe an anti-TNF agent before they prescribe other types of biologics for moderate-to-severe ulcerative colitis. This is because anti-TNF medications are the most studied treatments.

    Doctors may prescribe another type of biologic or a JAK inhibitor if the anti-TNF agent:

    Every person responds differently to these medications.

    Should You Try Combination Therapy

    Your doctor might want you to pair a biologic or biosimilar with another UC treatment. That could include a medication called an immunomodulator. These drugs ease inflammation by changing how your immune system works.

    Combination therapy might help your UC treatment work better. But you also boost your chances of side effects and drug-related health issues when you mix medication. Your doctor will help you decide whatâs best.

    Donât take biologics with tofacitinib . Thatâs a pill used to treat UC. Itâs in a class of drugs called JAK inhibitors. If youâre no longer taking biologics, your doctor might want you to take tofacitinib along with short-term corticosteroids if your symptoms are really serious.

    How Long Do You Take Biologics For Ulcerative Colitis

    A person can feel better within 68 weeks of taking biologics, although some drugs can take more time to be effective. When considering whether to stop, a person should consult with their doctor on the basis of criteria such as the current symptom level, any medication side effects, existing comorbidities, and more.

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    Biologic Therapy Can Lead To Long Periods Of Remission

    Biologics are broadly effective at reducing chronic inflammation in UC. Were 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, youll need to keep taking it to prevent your UC from flaring. Dont stop treatment without consulting with your doctor.

    Side Effect: Dry Mouth

    Novel Biologics for the Treatment of Ulcerative Colitis

    In addition to lubricating and cleaning your mouth, your body also produces saliva to help you eat and talk while protecting your mouth from tooth decay, bacteria, and viruses. The American Academy of Oral Medicine reports that over 1,100 prescription and over-the-counter medications cause dry mouth, including antidepressants, antidiarrheals, and opioids that patients with UC take. Moreover, SingleCare says that over 10 million Americans have medication-related dry mouth resulting in bad breath, tooth decay, gum disease, and mouth sores. A study referenced by MedicalNewsToday found that those with UC were three times more likely to have dry mouth than those without the disease.

    SingleCare recommends chewing sugar-free gum and drinking enough water to remain hydrated to reduce dry mouth. You could also try using a humidifier, reducing caffeine intake, and using mouthwash. Furthermore, several over-the-counter and prescription medications promote saliva production or replace mouth liquid. The National Institute of Dental and Craniofacial Research also recommends avoiding spicy and salty foods, as well as tobacco and alcohol.

    If your dry mouth fails to improve, speak to your doctor about a change in medication .

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    These Are Their Stories:

    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

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    Biologics May Lower The Need For Surgery

    Biologics can help protect some patients with moderate to severe ulcerative colitis from requiring surgery or hospitalization. The percentage of people with ulcerative colitis receiving biologic drugs has increased substantially since 1998, when infliximab became the first FDA-approved biologic. Now, about 16% of the patient population is estimated to use biologics.

    According to a 2020 study in Inflammatory Bowel Disease of more than 500 patients with UC, the introduction and utilization of biologics may be responsible for a marked decline in the number of patients who need to undergo surgery.

    In the pre-biologics era, about 20% of patients with ulcerative colitis needed a colectomy during their first hospitalization, and 30% required a colectomy within a year of their first hospitalization.Since the introduction of biologics, those rates have declined to 5.3 and 11.9%, respectively, providing potential evidence that biologics have spared many patients from losing their colons.

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    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.

    Reference

    Assessment Of Dose Escalation

    David’s Journey to Freedom from Ulcerative Colitis

    Dose escalation was defined differently for each biologic therapy, although the principle was the same. First, an induction period was calculated for each therapy, based on the labeled induction length, with an extra 1 week added for adalimumab and golimumab, and an extra 2 weeks added for infliximab and vedolizumab, to account for slight delays or variation in administration. Induction doses for adalimumab , golimumab , and vedolizumab were ignored for the purpose of calculating dose escalation . If the average dose during maintenance was at least 20% higher than the product label, this was considered dose escalation. For infliximab, since dosing is weight-based and weight was not available from the claims data, the index dose was used to derive an average daily baseline maintenance dose. This was calculated by dividing the total quantity administered at index by 56 . If this estimated average dose during maintenance was at least 20% higher than the index dose, this was considered dose escalation. For all medications, dose escalation was evaluated as the only persistent portion of the maintenance period because the gap might signal a treatment interruption.

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    Do Biologics Come With Side Effects And Risks

    Itâs safe to take these drugs on a long-term basis. And you may not have any issues with your treatment. But here are some things to consider:

    Higher odds of infection. Biologics donât make you sick. But these drugs can make it harder for your immune system to fight off germs. Thereâs a chance they might reactivate viruses that are already in your blood.

    Before you start biologic treatment, your doctor will check your blood for infections like:

    After you start a biologic, tell your doctor anytime you have signs of an infection. Watch for symptoms such as:

    • Diarrhea or bloody poop

    You can take steps to stay healthy. Wash your hands, wear a mask, and avoid close contact with sick people. And stay up to date on your vaccines. Your doctor will let you know which ones are right for you.

    Side effects and other reactions. Biologics go into your body one of two ways: a shot or through a vein in your arm. You may get pain, redness, swelling, or bruising where the medicine goes into your skin.

    Itâs possible to have an allergic reaction to a biologic. After a shot or infusion, get medical help right away if you notice:

    • Shortness of breath
    • Itchy skin, eyes, or lips

    Tell your doctor about any new symptoms that show up when you start your biologic.

    Itâs less common, but some biologics might affect your nervous system or cause a lupus-like reaction. That could trigger symptoms such as:

    • Numbness or tingling
    • Sudden swelling in your ankles or hands

    Side Effect: Mood Swings

    Health Navigator reports that ten different types of medications can affect your mood, three of which are commonly prescribed to those with UC. However, it’s often difficult for your doctor to determine whether your mood swings are due to your medication or the ailment they’re meant to treat. This is especially true for those with UC, as there is no cure for the disease, and you never know how it will affect you daily .

    Furthermore, a study published in The Lancet Gastroenterology & Hepatology found that over 30% of those diagnosed with IBD showed signs of anxiety, and a similar number had symptoms of depression. The number increased to nearly half in those not in remission. Moreover, medical professionals associated with Clinical and Experimental Gastroenterology refer to a study that shows UC patients often display symptoms of depression before a relapse, and others that indicate that anxiety and depression contribute to UC flares.

    If your moods are concerning, Health Navigator recommends that you speak to your doctor about changing doses or medications. However, it’s essential not to stop any medicine without talking to a physician, as that can worsen UC symptoms and mood swings. Some physicians also recommend seeing a therapist, learning relaxation techniques, and joining a support group to control your feelings .

    Recommended Reading: High Dose Remicade For Ulcerative Colitis

    Follow Up With Your Doctor

    You might need to try more than one biologic on your road to remission. Your doctor will tell you how to switch drugs safely. Biologics may not work very well when you start and stop treatment the wrong way.

    Biologics can ease your symptoms for months or years. But over time, they may not work as well as they did at first. Thereâs no way to predict when or if this will happen. But you can tell your doctor anytime you have symptoms such as diarrhea or bleeding. Before they change your treatment, theyâll want to rule out infections or other stomach disorders that look like UC.

    They can also run some tests to find out if youâre still responding to your biologic. If your medication stops working, your doctor may:

    • Switch to a different kind of biologic
    • Boost your dose
    • Add another immunosuppressant

    Your UC doctor will let you know how often you should come in for checkups. Be sure to keep up routine visits with your primary doctor, too. UC can occur alongside other health issues, so itâs a good idea to have more than one set of eyes on you.

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    What Makes Cura Different From Other Forms Of Curcumin

    Images Only: Combined 5

    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.

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    Approval And Usage Status Of Biologics

    The biologics which can be used in ulcerative colitis are different according to the countries. Golimumab was approved in the European Union, Canada, Switzerland, Russia, the United States, South Korea, and other countries.

    In the United Kingdom, only infliximab is recommanded in the acute severe ulcerative colitis according to NICE guideline.34 Other European countries such as Greece, France, Italy, Spain, Sweden, etc., infliximab, adalimumab, and golimumab are available for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or azathioprine, or who are intolerant to or have medical contraindications for such therapies. Recently, vedolizumab was approved for moderate to severe ulcerative colitis by the EMA.

    In the United States, infliximab, adalimumab, and golimumab are available in patients with moderately to severely active disease who have had an inadequate response to conventional therapy. The FDA approved vedolizumab recently.

    In Japan, infliximab and adalimumab can be used in patients with moderate to severe ulcerative colitis inadequate response to conventional therapy.

    The biologics which can be used for ulcerative colitis in South Korea are infliximab and adalimumab.35 Golimumab is expected to be available soon in South Korea.

    How Effective Are Biologics For Ulcerative Colitis

    Biologics can help bring ulcerative colitis into remission. Remission occurs when the symptoms of ulcerative colitis are gone.

    A 2020 review of research found that Remicade was the most effective biologic for reducing the signs and symptoms of ulcerative colitis in people who had never used biologics before.

    The same review found that Stelara was the most effective biologic for treating ulcerative colitis in people who had used anti-TNF agents in the past without satisfying results.

    Tofacitinib was also highly effective for treating ulcerative colitis in people who had previously used anti-TNF agents. Xeljanz is a JAK inhibitor, which is not a biologic.

    These results reflect average trends. Different medications may affect different individuals in different ways. People may need to try multiple medications to find one that works for them.

    The authors of one 2019 review reported that up to 30% of people with ulcerative colitis eventually need surgery to treat it. Some evidence has suggested that using biologics may delay the need for surgery.

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    How Fast Do Biologics Work

    Everyoneâs immune system is different. You may have fewer symptoms within 2 to 4 weeks. But it might take up to 8 weeks to see a big improvement.

    You might respond to biologic drugs faster if you:

    • Have lower levels of inflammation
    • Have never had IBD surgery
    • Are on another drug to suppress your immune system

    The type of biologic you take may also play a role. Some studies suggest anti-TNF inhibitors work the quickest. Integrin receptor antagonists may work a little slower. More research will provide the answers.

    How Long Do Biologics Take To Work

    Treating IBD: Biologics

    Biologic therapy can take time to start working. Some people living with Crohn’s disease or ulcerative colitis experience relief soon after their first dose. Depending on the medication, it can take several weeks to notice an improvement in symptoms. It is important to stick to your treatment plan and give your biologic medication time to take effect.

    Several MyCrohnsAndColitisTeam members have shared questions and experiences about how long it takes biologic drugs to work. One member asked, “Has anyone been on Humira? How long does it take to work?” In response, another member offered, “I’ve been on Humira for eight months. It worked for me right away.”

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    Check In Check Up: 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.

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