Dose Optimization Of Certolizumab Pegol And Golimumab
Although assays are not commercially available to assess drug levels or antibodies to certolizumab pegol or golimumab, clinical trial data for both agents suggest that antibodies can form to both drugs, and the incidence of antibody formation to the drugs decreases with the use of immunomodulators. Dose intensification was also allowed in the MUSIC trial, discussed below, and may be an option in patients who are not responding to standard dosing of certolizumab pegol.
In a trial assessing golimumab maintenance therapy for patients with UC, the incidence of antibodies through week 54 was 2.9% . The rate was lower for patients who received concomitant immunomodulators vs patients who were on golimumab monotherapy .
Envisioning Adalimumab For Paediatric Patients With Ulcerative Colitis
Adalimumab has been shown to induce clinically meaningful remission and response in children with moderate-to-severe ulcerative colitis . The double-blind, randomized, controlled, phase III ENVISION I study assessed the efficacy and safety of adalimumab in children aged 417 years with MSUC who were randomly assigned to receive high-dose or standard-dose adalimumab induction and observed up to 52 weeks. In the main study, 23% of patients had treatment-emergent serious adverse events.
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What Should I Ask My Doctor
If you have psoriasis or an inflammatory bowel disease, Stelara and Humira may help treat your condition. They have some similar serious side effects and warnings.
A main difference between these drugs is how often you use them. Once youre on a maintenance dose, youll receive Stelara once every 8 or 12 weeks. Humiras maintenance dose is one injection every other week.
Also, Stelara and Humira arent in the same exact drug class. So one may be a better fit than the other based on your condition, overall health, past or current treatments, and medical history.
If you have questions about these drugs for your condition, talk with your doctor or pharmacist. Ask about any concerns you have. Here are a few examples to get you started.
- I take other medications. Do either Stelara or Humira interact with them?
- I have cardiomyopathy . Is Stelara or Humira a better option for my psoriatic arthritis?
- How long does it take each drug to start working? Will one drug improve my symptoms faster than the other?
- Would Stelara or Humira be a better fit for me based on my health and medical history?
- Are there any side effects that happen from using either drug long term?
- How long have Stelara and Humira been used for my condition?
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Is It Important To Treat A Flare Early Or Is It Ok To Wait A Bit
Inflammation typically does not resolve without treatment and early intervention has a better outcome than waiting to treat. At an early stage of a flare, a more optimal baseline treatment is often enough to get the inflammation under control. If you wait, there is a greater risk that you might need drugs with greater side effects, such as oral steroids. By waiting, you will have to manage longer with your symptoms before getting relief. Living with constant or longer periods of inflammation might increase your risk for future complications, as inflammation might cause damage to the gut wall that accumulates in severity with each flare.
If you are experiencing worsening symptoms, you have probably already had the flare for some time without symptoms. Evidence shows that a stool test for inflammation in the colon, called fecal calprotectin, is often elevated for two to three months before any symptoms appear. Your colon might also start to show visual evidence of inflammation before you have symptoms, or at least indicate an increased risk for a flare.
What Are The Side Effects Of Humira
With any medication, there are risks and benefits. Even if the medication is working, you may experience some unwanted side effects.
Contact your doctor immediately if you experience any of the following:
- Low blood cell counts: Fever that doesn’t go away, getting fevers more often, easy bruising, pale skin, bleeding
- Heart failure: Shortness of breath, swelling in the legs, ankles, or feet, irregular heartbeat, lower ability to exercise, tiredness, weakness
The following side effects may get better over time as your body gets used to the medication. Let your doctor know immediately if you continue to experience these symptoms or if they worsen over time.
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Severe Side Effects Of Humira
Nowadays, many attorney groups are waiting for you to reach out to them to file a lawsuit against Humira because of these serious injuries you or your loved one experienced.
The USA Food and Drug Administration has recognized Humira as a dangerous drug that can cause Humira side effects like depression, anxiety, and hair loss, including risks for potentially life-threatening side effects.
No surprise that it also at the top of the list of drugs with the most adverse event reports reaching the FDA.
Facts: In September 2018, the State of California filed a lawsuit against AbbVie, alleging the manufacturer gave illegal kickbacks to most physicians to encourage them to prescribe Humira to patients.
In addition to tuberculosis black-box warning, today, Humira carries a warning for invasive fungal infections, such as histoplasmosis caused by Histoplasma, as well as Legionella and Listeria infections. But this was not always the case. For years, Humira pens black-box warning only included the risk of TB.
If you have any of these below severe side effects and symptoms of Humira, stop taking it and call your doctor immediately!
Does Stelara Have A Black Box Warning
No, Stelara doesnt have a black box warning, which is also called a boxed warning. These warnings are used to alert healthcare professionals and patients about very serious side effects that can happen with some drugs.
Stelara can cause serious side effects. But the Food and Drug Administration hasnt required the manufacturers of Stelara to include a black box warning with this medication.
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Remicade Vs Humira: Main Differences And Similarities
Remicade and Humira are two medications that can treat inflammatory conditions such as rheumatoid arthritis, Crohns disease, and ulcerative colitis. Both medications are classified as monoclonal antibodies that work by blocking specific immune responses. By blocking inflammatory processes, Remicade and Humira can provide valuable relief for certain conditions. Their similarities and differences will be reviewed here.
What Are Biologics For Ulcerative Colitis
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:
- infliximab
- adalimumab
- golimumab
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:
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Side Effects And Special Concerns
According to Xeljanz prescribing information, care should be taken when prescribing this medication to anyone who:
- Currently has a serious infection
- Is at risk for perforation of the intestines
- Has a low count of neutrophils or lymphocytes, both types of white blood cells
- Has a low hemoglobin level
From the results of clinical trials in ulcerative colitis patients receiving 10 mg of Xeljanz twice a day, the most common side effects and the percentage of patients in which they occurred included:
- Common cold
- High blood pressure
Differences In Administration Efficacy And Conditions Treated
Robert Burakoff, MD, MPH, is board-certified in gastroentrology. He is the vice chair for ambulatory services for the department of medicine at Weill Cornell Medical College in New York, where he is also a professor. He was the founding editor and co-editor in chief of Inflammatory Bowel Diseases.
Biologics are a newer class of drugs used to treat the inflammation that is caused by inflammatory bowel disease . This is a broad range of medications that each work in slightly different ways with different standards of administration and dosing. Some are approved to treat just one form of IBD, while others are used to treat both Crohn’s disease and ulcerative colitis.
Because biologic drugs temper the immune response, people taking them are prone to certain infections. It’s important, therefore, to take steps to reduce your vulnerability. People with IBD should receive vaccinations, ideally before starting a biologic, although many immunizations can also be given while taking a biologic.
According to 2020 guidelines, a biologic drug should be used first-line for treatment in people with moderate to severe ulcerative colitis.
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Can I Switch Between Stelara And Humira
The short answer: Its possible.
Details: Stelara and Humira are both biologic disease-modifying antirheumatic drugs . Biologics are newer, targeted therapies derived from living sources. And DMARDs suppress certain parts of your immune system to help reduce inflammation . This helps prevent damage to your healthy tissues and symptoms of your condition.
These drugs are both used to treat similar autoimmune or inflammatory conditions, such as psoriatic arthritis or ulcerative colitis . So you may be able to switch between Stelara and Humira.
In some cases, your doctor may recommend the switch. For example:
- If you have psoriatic arthritis thats not controlled with Stelara, your doctor may suggest switching to Humira. This switch is recommended by the American College of Rheumatology.
- According to American Gastroenterological Association treatment guidelines, Stelara and Humira are both first-choice treatments for moderate to severe ulcerative colitis. So if you need to switch because of side effects or costs, it may be possible.
However, choosing to switch between these drugs isnt always a simple decision. Your doctor may or may not recommend it based on many factors, such as:
- your condition and other medical treatments
- your experience with past treatments
- your risk for serious side effects
- any side effects youve had
- your other medications
- recommendations from the latest treatment guidelines
- drug costs or availability
Dietary And Lifestyle Modifications
As most nutrients are absorbed higher up in the digestive tract, those with ulcerative colitis generally do not have nutrient deficiencies however, other factors might influence your nutritional state. Disease symptoms may cause food avoidance, leading to food choices that might not provide a balanced diet. If bleeding is excessive, problems such as anemia may occur, and modifications to the diet will be necessary to compensate for this.
Generally, better overall nutrition provides the body with the means to heal itself, but research and clinical experience show that diet changes alone cannot manage this disease. Depending on the extent and location of inflammation, you may have to follow a special diet, including supplementation. It is important to follow Canadas Food Guide, but this is not always easy for individuals with ulcerative colitis. We encourage you to consult a registered dietitian, who can help set up an effective, personalized nutrition plan by addressing disease-specific deficiencies and your sensitive digestive tract. Some foods may irritate the bowel and increase symptoms even though they do not worsen the disease.
In more severe cases, it might be necessary to allow the bowel time to rest and heal. Specialized diets, easy to digest meal substitutes , and fasting with intravenous feeding can achieve incremental degrees of bowel rest.
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Ulcerative Colitis Study: Ozanimod Tops Adalimumab Equals Vedolizumab
Laird Harrison
LAS VEGAS In a comparison of data from clinical trials for ulcerative colitis, ozanimod appeared to be more useful than adalimumab and as useful as vedolizumab .
The US Food and Drug Administration approved ozanimod for ulcerative colitis in May of this year, and clinicians are trying to figure out where it fits into the armamentarium, said Marla Dubinsky, MD, professor of pediatrics and medicine in the Division of Pediatric Gastroenterology at Icahn School of Medicine at Mount Sinai, in New York City.
“It’s an extremely heterogeneous disease,” Dubinsky told Medscape Medical News. “A lot of these indirect comparisons are being done, because these therapies are coming out so quickly.”
No clinical trials have compared either ozanimod to adalimumab or ozanimod to vedolizumab head to head, so Dubinsky and colleagues pitted the drugs against each other by matching data from individual patients from the True North trial of ozanimod to published data from the ULTRA 1 and 2 trials of adalimumab and the GEMINI 1 trial of vedolizumab.
She presented the findings here at the American College of Gastroenterology 2021 Annual Scientific Meeting.
From the 1990s until 2014, physicians relied heavily on tumor necrosis factor inhibitors, such as adalimumab, to treat ulcerative colitis, Dubinsky said. Although often effective, these drugs can increase patients’ vulnerability to infections and malignancies.
Patients Having Received First
Baseline characteristics
Infliximab was prescribed as first-line anti-TNF treatment in 126 patients , whereas adalimumab was prescribed in 34 patients . The median time interval between disease onset and the initiation of maintenance treatment with infliximab or adalimumab as first-line anti-TNF treatment was 3 years.
The medications taken before the initiation of an anti-TNF agent were variously 5-aminosalicylate , systemic steroids , azathioprine , methotrexate , rectal therapy , cyclosporine , enteral or parenteral nutrition , and investigational drugs .
A total of 130 patients were receiving other treatments on initiation of first-line treatment with an anti-TNF agent: 60 patients were receiving 5-aminosalicylate, 88 patients were receiving systemic steroids, 57 patients were receiving azathioprine, 11 patients were receiving methotrexate, 10 patients were receiving rectal therapy, and 3 patients were receiving enteral or parenteral nutrition.
Detailed data on all treatments before or on initiation of first-line treatment with an anti-TNF agent are given in Supplementary Table S1.
Retention rates and reasons for anti-TNF withdrawal
Persistence of first-line treatment with an anti-TNF agent
The overall mean persistence of first-line treatment with an anti-TNF agent was 3.1 years, with values of 3.4 years for infliximab and 2.1 years for adalimumab. The difference in persistence between the infliximab and adalimumab subgroups was not statistically significant .
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Management Of Ulcerative Colitis
The main treatment goals for ulcerative colitis are the induction and maintenance of clinical and endoscopic remission. As far as mild-to-moderate disease is concerned, the oral and topical aminosalicylates represent the standard therapy for achieving this outcome. In the event of inadequate response to aminosalicylates and in patients with moderate-to-severe disease, systemic corticosteroids are the best option for inducing remission. Patients with active ulcerative colitis who do not have significant clinical improvement after 24 weeks of an appropriate course of corticosteroids are classified as corticosteroid-refractory. Anti-tumor necrosis factor-alpha monoclonal antibodies represent the best available option for this group of patients, achieving clinical and endoscopic remission without prolonged steroid exposure.
Patients with acute, severe ulcerative colitis need to be hospitalized and treated with intensive intravenous corticosteroids . A lack of improvement within 35 days of intensive treatment is an indication for rescue therapy or surgery. A recent open-label trial involving 115 patients with acute, severe ulcerative colitis who were refractory to intravenous corticosteroids and randomized to receive either intravenous cyclosporine or infliximab has shown no significant differences in treatment failure .
What Is The Safest Biologic For Ulcerative Colitis
The benefits of biologics may outweigh the potential risks in people with moderate-to-severe IBD.
However, biologics can affect how the immune system works. Specifically, they may impact the immune systemâs ability to ward off certain infections.
The risk of infection tends to be higher with anti-TNF agents than with other types of biologics.
The 2020 review of research found that the overall rate of serious infections in people using biologics was low. Entyvio was the safest biologic for treating ulcerative colitis. It was linked to the lowest number of infections.
The authors ranked Stelara as the next safest biologic for treating ulcerative colitis.
Biologics may carry other risks of side effects. A person should speak with a doctor about the potential risks of biologics before they use them.
However, biologics are relatively new medications. For this reason, long-term safety data are limited.
Scientists have completed fewer long-term studies on Entyvio or Stelara. The available data suggest that these biologics are safer than anti-TNF agents.
People with moderate-to-severe ulcerative colitis may need to use biologics on an ongoing basis to keep the condition in remission. Stopping treatment with biologics may cause a relapse, during which symptoms return.
More research is necessary to confirm if and when people can stop using biologics without experiencing a relapse.
Some research has linked biologics to modest weight gain in people with ulcerative colitis.
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Humira Gets Ok For Ulcerative Colitis
Adalimumab has been approved to treat moderate to severe ulcerative colitis in adults who don’t respond to corticosteroids or immunosuppressive drugs, the FDA announced Friday.
Underlying the approval were two clinical trials involving a total of 908 ulcerative colitis patients, the agency said.
“Results from both studies showed 16.5% to 18.5% of patients treated with Humira achieved clinical remission compared with 9.2% to 9.3% of patients receiving placebo,” according to the FDA’s announcement.
“Additionally, in the second study, 8.5% of patients treated with Humira sustained clinical remission compared with 4.1% of patients treated with placebo.”
The agency noted that it remained uncertain whether adalimumab, an inhibitor of tumor necrosis factor , is effective in patients not responding or losing response to other drugs in its class.
An FDA advisory committee had voted 12-2 last month to recommend adalimumab’s approval for ulcerative colitis, despite an agency staff review that questioned whether the difference in remission rates between the drug and placebo was clinically meaningful.
Currently, the only other TNF inhibitor approved for ulcerative colitis is infliximab .
Adalimumab for ulcerative colitis is to be administered with a first dose of 160 mg and a second dose of 80 mg 2 weeks later, with maintenance dosing at 40 mg every 2 weeks thereafter.