Adalimumab In The Treatment Of Moderate
Sandborn WJ, van Assche G, Reinisch W, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2012 142:257-265.e13.
Moderately to severely active ulcerative colitis is typically managed with conventional therapy consisting of corticosteroids and/or immunosuppressive agents such as azathioprine and 6-mercaptopurine. Despite long-term, high-dose therapy, many patients fail to respond to treatment or achieve disease remission. Infliximab , an intravenously administered monoclonal antibody directed against tumor necrosis factor alpha , is approved by the US Food and Drug Administration for management of UC in patients who have had an inadequate response to conventional therapy. The ACT 1 and ACT 2 trials demonstrated the efficacy and safety of infliximab for this indication significantly higher proportions of patients receiving infliximab achieved a clinical response compared with patients receiving placebo.1
The rate of clinical remission at Week 8 among 186 patients who were naive to anti-TNF- therapy was significantly higher in those treated with adalimumab compared with those receiving placebo . To further investigate the efficacy and safety of adalimumab in patients with moderate-to-severe UC and to gather long-term data, the ULTRA 2 study was conducted.3
Important Safety Informationabout Entyvio
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call .
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 al27 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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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.
How Should I Use Humira
Use Humira exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Humira is injected under the skin. A healthcare provider will teach you how to properly use this medicine by yourself.
Do not start using this medicine if you have any signs of an infection. Call your doctor for instructions.
Read and carefully follow any instruction sheet provided with your medicine. Do not use Humira if you do not understand the instructions for proper use. Ask your doctor or pharmacist if you have any questions.
The dose schedule for Humira is highly variable and depends on the condition you are treating. Follow your doctor’s dosing instructions very carefully.
Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed color, or has particles in it. Call your pharmacist for new medicine.
Humira affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.
Store this medicine in its original carton in a refrigerator. Do not freeze. If you are traveling, carefully follow all patient instructions for storing your medicine during travel. Avoid extreme heat or cold.
Throw away any Humira that has become frozen.
Usual Adult Dose for Rheumatoid Arthritis:
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Do Stelara And Humira Work The Same Way
Stelara and Humira both work by suppressing overactive parts of your immune system. This helps lower inflammation that causes tissue damage and the symptoms of your condition. But they dont work in exactly the same way.
Heres how these drugs compare:
- Stelara lowers inflammation by blocking interleukin-12 and interleukin-23. These are inflammatory substances that your immune system makes in response to antigens . If your immune system overproduces these substances, it causes too much inflammation that can damage healthy tissues. This damage brings about symptoms of your condition.
- Humira lowers inflammation by blocking tumor necrosis factor .TNF is another substance that your immune system makes that leads to inflammation. It signals other immune cells so they can help fight infections. If your immune system makes too much TNF, it can cause too much inflammation that damages healthy tissues. This damage causes symptoms of your condition.
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The drug was developed by biopharmaceutical company AbbVie, which was founded in January 2013 by US-based healthcare company Abbott Laboratories as a spin-off of its research-based pharmaceuticals business.
HUMIRA is available in a single-dose pre-filled pen as a clear and colourless solution in 80mg/0.8ml, 40mg/0.8ml and 40mg/0.4ml dosage strengths for subcutaneous administration.
It is also available as single-dose pre-filled syringe in 80mg/0.8ml, 40mg/0.8ml, 40mg/0.4ml, 20mg/0.4ml, 20mg/0.2ml, 10mg/0.2ml and 10mg/0.1ml dosage strengths.
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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:
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.
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Adalimumab In Ulcerative Colitis
Adalimumab is a human monoclonal immunoglobulin G1 antibody to TNF that is subcutaneously administered at a standard induction dose of 160 mg, followed by 80 mg after 2 weeks. Maintenance doses are then scheduled at 40 mg every other week .14 This drug has been shown to be effective for inducing and maintaining remission in patients with active, moderate-to-severe luminal or perianal Crohns disease patients naïve to anti-TNF or patients with previous loss of response or intolerance to infliximab.1519
As far as ulcerative colitis is concerned after the publication of the results of the two pivotal, randomized placebo-controlled double-blind trials ,20,21 adalimumab was approved for use in patients with moderate-to-severe active disease and in those who were nonresponders or intolerant to conventional therapy. In these trials, involving more than 1000 patients with moderate-to-severe active ulcerative colitis, adalimumab was compared with placebo with regard to the efficacy of induction and as a maintenance treatment, assessed after 8 and 52 weeks, respectively.
What Are The Benefits Of Biologics
Because of chronic diarrhea, frequent stools, and stomach pain, UC can interfere with the quality of your life.
Some individuals with mild UC respond well to treatment, and the disease goes into remission with an anti-inflammatory medication and lifestyle remedies. If youre living with moderate to severe UC, however, you may only achieve remission with a biologic.
Remission not only alleviates common UC symptoms, it can also reduce your risk of certain complications of the disease. For example, frequent bouts of diarrhea and bloody stools increase the likelihood of dehydration and iron deficiency anemia.
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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.
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:
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:
JAK inhibitors can include
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What Should I Avoid While Using Humira
Do not inject Humira into skin that is bruised, red, tender, or hard.
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
Do not receive a “live” vaccine while using adalimumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella , polio, rotavirus, typhoid, yellow fever, varicella , or zoster .
What Does Humira Cost Without Insurance
Generally, the cost of Humira is more expensive without insurance than with insurance. The factors that affect your cost of Humira without insurance include your Humira dosage and the pharmacy you use.
Your cost without insurance also depends on whether you qualify for the manufacturers patient assistance program called myAbbVie Assist. If you do not have insurance and have difficulty paying for Humira, this program could help cover your cost. You can apply for the program online or by calling 800-222-6885.
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Most Eligible Commercially Insured Humira Patients Pay As Little As $5/month*
Most eligible, commercially insured patients pay as little as $5 per month for their HUMIRA with copay assistance. If you are a commercially insured patient, you may be able to reduce your out-of-pocket cost with the HUMIRA Complete Savings Card.
Arava and Plaquenil are registered trademarks of their respective owners.
HUMIRA Use for Crohns Disease
HUMIRA is a prescription medicine used to treat moderate to severe Crohns disease in adults and children 6 years of age and older.
HUMIRA Use for Ulcerative Colitis
HUMIRA is a prescription medicine used to treat moderate to severe ulcerative colitis in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
Inflammation And Your Immune System
Inflammation is your immune systems normal reaction to protect your body from bacteria, viruses, and other potentially harmful substances. However, for people with UC, the immune system is mistakenly triggered to attack the inner lining of the large intestine. This results in excess inflammation, leading to the symptoms of UC.
Although it isnt known for sure what triggers the excess inflammation, too much of the protein TNF alpha may be to blame. Your bodys immune system naturally produces TNF alpha, but if you have UC, your body may be producing too much of it.
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Who Should Consider Biologics
Biologics may be ideal for those who dont respond to conventional UC medications. But this therapy isnt recommended for everyone. Talk to your doctor to see if youre a good candidate for this particular treatment.
Biologics are similar to other immunosuppressant drugs because they also lower your immune systems fighting ability and increase your risk of infection. As a result, biologics are typically not recommended for people who have certain diseases or a weakened immune system.
These conditions include:
- heart failure
Your doctor may also discourage biologics if youve had an organ transplant.
In addition, biologics increase the risk of reactivating an inactive tuberculosis infection. As a result, youll need TB testing, and possibly treatment, before beginning therapy.
How Do You Take Adalimumab
Adalimumab is administered by subcutaneous injection at regular intervals . Subcutaneous means that an injection is given into the fat between your skin and muscle.
Some people administer the injection themselves at home, while others receive it from a nurse. If you are considered suitable to self-administer you will receive full training from a qualified professional who will teach you how to do it and observe you the first couple of times. If you are self-administering adalimumab your dosages will be delivered to you in loaded pens with a short needle under the cap. These pens need to be kept refrigerated.
The first time you receive adalimumab will be your loading dose. This will be a higher dose than the usual dose you will receive. The loading dose is usually 160mg of adalimumab – four loaded pens. The second dose is taken 2 weeks later – usually 80mg or 2 loaded pens. After that you will usually take 40mg every two weeks.
If you are self-administering your adalimumab you will be provided with a sharps bin to discard of the used pen.
Some people report that adalimumab stings when it is administered.
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