Ulcerative Colitis And Overcoming The Fear Of Using Biologics
Ulcerative colitis can have a significant impact on your life. This inflammatory bowel disease causes chronic inflammation and ulcers in your large intestines.
You may have led an active life before developing UC. Since receiving a diagnosis of UC, however, you may have limited activity outside the house because youre fearful of having a flare-up in a public place.
Although this disease is unpredictable, several treatments can help manage symptoms and may induce remission. Remission is a period marked by no symptoms or flare-ups. It occurs when therapy successfully controls inflammation.
After diagnosing UC, your doctor may prescribe an anti-inflammatory medication as the first place to start. This medication treats symptoms of UC by reducing inflammation in your intestines.
If this medication doesnt work, the next treatment is often an immunosuppressant drug. UC can develop from an abnormal immune system response to normal bacteria in your gut. These medications treat the condition by suppressing your immune system.
Your doctor may prescribe an immunosuppressant along with an anti-inflammatory medication.
Anti-inflammatory and immunosuppressant drugs dont always bring about remission or adequately relieve symptoms of UC. Some people require a different therapy called biologics.
But even if your doctor recommends biologics, you may be hesitant to begin these medications. Learning more about this treatment may ease some of your worries.
Tips For Taking Humira
A person can inject themselves with Humira after a doctor has shown them how. An individual will usually inject Humira into the front of their thigh or abdomen, and using different injection areas helps reduce the pain and lower the risk of infection.
To inject Humira, a person should:
These medications, such as prednisone, can reduce inflammation in the digestive system. A person may need to take them for a couple of months, either orally or as an injection.
Steroids have several side effects, including:
- increasing the risk of infection
- causing weight gain
Humira In Ulcerative Colitis Reviews
With the recent approval of Humira by the FDA, there is a growing need for ulcerative colitis patient reviews of their experiences with this medication. Like some other biologics, Humira helps to stop the communication of a specific part of the immune systems inflammatory response.
Many UCers are concerned that immune suppresants such as Humira will stop their immune system from working. That is not entirely true. Humiras main goal is to stop the TNF alpha section of the immune response. .
Although Humira was approved by the FDA much later than Remicade which is a similar immune suppressant medication, there has been research and studies with Humira as far back as 1999 when it was still under development.
Like all medications, doctors should be consulted considerably when the decisions are being made to potentially start medications. Humira is no different. There are many reported potential side effects, and you as a patient should be well aware of what these are.
If you have experience with taking Humira for treating your ulcerative colitis, please consider leaving a review of your experience on this page.
Did not work for me
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Traditional Treatment Cautions Humira And Ulcerative Colitis
You make an appointment to see your doctor because your psoriasis is flaring. He takes a look and then whips out his prescription pad to order one of the following:
. A prescription strength topical treatment
. oral and injection therapy
. over the counter drugs
Any of these treatments may work fine to relieve your symptoms and make you feel better for now. The trouble with conventional treatment methods is that they rarely work to cure the underlying cause of this skin condition and that can leave you suffering repeat attacks. Still it is important to know what helps are available, and how they may help or hurt your chance of treatment success.
Topical Ointments Humira and Ulcerative Colitis
Topical ointments are used at the first sign of psoriasis. If caught early enough they can sometimes stave off a full-blown attack. Unfortunately, most people report becoming immune to them when used often, which makes them useless for long term use. Still, using the occasional cream or gel can help relieve some of your symptoms. Steroids
Both topical and internal steroids can be prescribed to help ease psoriasis swelling inflammation and itching. Immunomodulators
An immune suppressing drug that was originally used to help transplant patients beat organ rejection, Cyclosporine helps to inhibit T lymphocyte production so that scaly plaque is unable to grow on the surface of the skin.
Oral Retinoid Humira and Ulcerative Colitis
. stretch marks
Humira Mechanism Of Action
The active substance in adalimumab is a monoclonal antibody designed to recognise and bind to TNF, a naturally occurring cytokine that plays an integral role in the inflammatory process and immune responses.
Adalimumab targets and blocks a source of inflammation by binding specifically to TNF alpha, an inflammation-causing protein, which helps to reduce the inflammation in the body that can lead to ulcerative colitis symptoms.
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The Pros And Cons Of Biologics For Ulcerative Colitis
The introduction of biologics has changed treatment for many people with ulcerative colitis. Heres what you need to know about the risks and benefits.
Andrew Brookes/Getty Images
Over the past 15 years, treatment options for ulcerative colitis 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 Crohns 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 patients own immune system is what sets them apart from some other medications for ulcerative colitis, Dr. Tsynman says.
Clinical Trials On Humira
The FDA approval of the drug for ulcerative colitis in paediatric patients was based on the outcome of a phase three randomised, double-blind, multicentre study, ENVISION I.
The study evaluated the efficacy, safety and pharmacokinetics of adalimumab administered subcutaneously in child subjects with moderate to severe ulcerative colitis.
A total of 77 patients were given 2.4mg/kg of the drug at week zero, followed by 1.2mg/kg at week two and 0.6mg/kg at weeks four and six. A further 16 patients received open-label treatment with adalimumab at the higher dosage.
In the study, 62 patients who demonstrated clinical response per Partial Mayo Score were randomised to receive a double-blind placebo, 0.6mg/kg of adalimumab, every other week, or every week between week eight and week 52.
The co-primary endpoints of the study included clinical remission per PMS at week eight, and clinical remission per Mayo Score at week 52 in patients who achieved clinical response per PMS at week eight.
Clinical remission was defined as a PMS or Full Mayo Score less than or equal to two and no individual sub-score greater than one.
The clinical trial showed that treatment using adalimumab reached the co-primary endpoints of clinical remission at week eight and maintained remission at week 52 in patients who responded at week eight.
The most common adverse side effects reported during induction and maintenance periods included a headache and the worsening of ulcerative colitis.
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Humira Approved For Ulcerative Colitis Treatment
Sept. 28, 2012 — The FDA has approved Abbott’s Humira for the treatment of moderate to severe ulcerative colitis.
Humira now is approved for both forms of inflammatory bowel disease : ulcerative colitis and Crohn’s disease.
It was already approved to treat Crohnâs disease, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, juvenile idiopathic arthritis, and ankylosing spondylitis.
For ulcerative colitis, Humira is approved when other drugs to suppress immune responses haven’t worked.
“Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individualâs needs,” says Donna Griebel, MD, director of the FDA’s gastroenterology division. “Todayâs approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy.”
Clinical studies tested Humira in treating ulcerative colitis patients with moderate to very severe disease. Clinical remission — defined as relatively mild disease — happened after eight weeks of Humira treatment in 16.5% to 18.5% of patients, compared to 9.2% to 9.3% of patients given an inactive placebo.
The FDA-approved dosing regimen for Humira for ulcerative colitis begins with an initial dose of 160 milligrams, a second dose two weeks later of 80 mg, and a maintenance dose of 40 mg every other week, thereafter. The drug is given by injection.
Safety And Side Effects
The risk of experiencing side effects is an important factor to consider when choosing to take a biologic drug.
The mild side effects associated with these medications can include:
- multiple sclerosis
You must get a test for tuberculosis and hepatitis before you can start a biologic.
Also notify your doctor if you have been around a person with chicken pox, shingles, or tuberculosis, or if you are scheduled to receive a vaccine or have surgery.
The risk of biologics to unborn babies is unknown. Women of child-bearing age should use contraception while on biologics. Your doctor may ask you if you are thinking of becoming pregnant before you start a biologic. If you are planning to become pregnant, talk with your doctor about when to stop using contraception and biologics. The labeling of biologics advises these medications not be used by pregnant women unless necessary. If you do become pregnant while taking a biologic, your doctor may tell you to continue to take the biologic while monitoring you and your baby closely. Large international registries have not shown an increase in the risk of birth defects in women on biologic therapy.
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How Does Adalimumab Work
Crohns disease and ulcerative colitis have been linked to an increase in certain proteins – including one called tumor necrosis factor . Your bodys immune system naturally produces TNF.
An increase in TNF is linked to an increase in inflammation in the bodys digestive system – which can lead to a worsening of inflammatory bowel disease symptoms.
Adalimumab is one of a group of medications which target TNF proteins, bind to them and block them. This helps to prevent inflammation in the body which is hoped will reduce IBD symptoms. The immune system is also suppressed. This can mean that people taking adalimumab are more prone to picking up illnesses and infections.
Ulcerative Colitis Causes And Symptoms
Ulcerative colitis is a chronic inflammatory bowel disorder characterised by inflammation of the large intestine.
The aetiology of ulcerative colitis is unknown, but research suggests that an abnormal reaction of the immune system causes inflammation and ulcers on the inner lining of the large intestine interaction. Ulcerative colitis is classified into four types, namely ulcerative proctitis, proctosigmoiditis, left-sided colitis and pancolitis.
Typical symptoms of the disease include abdominal pain, bloody diarrhoea, mild to severe bowel urgency, incontinence, weight loss and fatigue.
As children generally have more extensive disease and significant morbidity, there remains significant unmet treatment needs for children with moderate to severe ulcerative colitis compared to adults.
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How Common Are These Side Effects
Common: Somewhere between 1 in every 10 people to 1 in every 100 people taking adalimumab may develop this side effect.
Uncommon: Somewhere between 1 in every 100 people to 1 in every 1000 people taking adalimumab may develop this side effect.
Rare: Somewhere between 1 in every 1000 people to 1 in every 10,000 people taking adalimumab may develop this side effect.
This is not a full list of side effects. For more information see the Patient Information Leaflet provided with your medicine or visit medicines.org.uk/emc/.
We encourage you to report any side effects to the Medicines and Healthcare Products Regulatory Agency through the Yellow Card scheme. Your doctor should also report it. Report your side effect at yellowcard.mhra.gov.uk.
I have to cope with certain side effects such as pain at the site of injecting and flu-like symptoms such as headache and general achiness but this usually subsides within a couple days. Dont be scared it is easier than it seems at first.
Its not safe to have live vaccines while taking adalimumab. It can take up to four months after your last dose for adalimumab to completely leave your body. However, its safe to have live vaccines 3 months after your last dose. Ask your IBD team to make sure your vaccinations are up to date before you start adalimumab, or if youre planning to travel. If youve recently had a live vaccine you may have to wait 4 weeks before starting adalimumab.
In the UK, live vaccines include:
Adalimumab In Ulcerative Colitis: Real
Although adalimumab has been recently licensed, multiple lines of evidence from open-label and retrospective studies on adalimumab, administered for compassionate use in ulcerative colitis patients, have been available for several years . Oussalah et al first presented data on 13 ulcerative colitis patients treated with adalimumab in 2008. All of the patients had been previously treated with infliximab, and most of them had been previously treated with thiopurines. Patients were treated with adalimumab, with an induction dose of 160/80 mg at weeks 0 and 2, and then maintained with 40 mg EOW. The primary endpoint was defined as the proportion of patients on adalimumab therapy during the study. After a median follow-up of 41 weeks, the percentage of patients remaining on adalimumab therapy was 32.5%. Eight patients discontinued adalimumab: six due to colectomy, one due to lack of response, and one due to an exacerbation of psoriasis. No significant differences were found in adalimumab withdrawal and colectomy rates between the patients who lost response to infliximab and those who became intolerant. From this small cohort of difficult-to-treat patients who had already been treated with all of the main available therapies, adalimumab treatment potentially avoided colectomy in about half of them.
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How Does Humira Treat Crohns
Humira is an injectable medication that is part of a group of medications called biologics. Doctors prescribe it alone or in combination with other medications to help relieve symptoms. Other examples of biologics include infliximab and certolizumab pegol .
Health experts do not know the exact causes of Crohns disease. Many believe a combination of genetic and environmental factors makes the immune system response overactive.
The system produces certain protein molecules called tumor necrosis factor , which ordinarily help the body fight off infection. In people with Crohns, there is an excess of TNF, which circulates even when the body is not fighting infection. The overactive response of TNF causes inflammation of the gut and the resulting symptoms of Crohns.
Drugs, such as Humira,
Humira can also increase the chances of developing skin cancer, lymphoma, and other types of cancer.
Some of these side effects may go away within a couple of days or weeks. However, if they become more severe or do not resolve, a person can talk with a doctor or pharmacist.
The Link Between Psoriasis And The Immune System
No one ever really considered that the immune system had any real role in psoriasis, or its painful outbreaks. Not until a new drug Cyclosporine was offered to arthritis patients. What happened next was both surprising and unexpected. Patients who were prescribed the immune suppressing drug for their arthritis symptoms , began to report a decrease in their skin attacks. Without warning, researchers were faced with the theory that the immune system could be causing psoriasis.
It didnt take long before researchers began to figure out the mystery of psoriasis in regards to how the immune system can impact it.
The Role of the Immune System on the Skin
The immune system is responsible for standing guard and attacking any invaders which penetrate the body. Since the skins main job is to act as the bodys first defense mechanism against invasion, it is no wonder that the immune system works in close connection with each layer of the skin. Heres how it all works:
1. Immune cells patrol the entire body for dangers. How Well Does Humira Work for Ulcerative Colitis
2. When an invader is detected, these immune send out chemical and nervous system messages to the immune system to ready itself for an attack
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What Is The Most Important Information I Should Know About Humira
You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.
- Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
- Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, your chance of getting two types of skin cancer may increase. These types are generally not life-threatening if treated tell your doctor if you have a bump or open sore that doesnt heal.