Humira (adalimumab) and its uses
Doctors prescribe Humira to treat rheumatoid arthritis, chronic plaque psoriasis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and non-infectious uveitis.
Humira is a biologic drug. Scientists normally make biologics using protein antibodies from a living organism, such as humans, animals, microorganisms or yeast.
They produce the proteins using DNA technology. It is a kind of genetic engineering.
People normally take Humira at home, using a syringe or a pen device that already contains the medication. They cannot take it by mouth, because the human digestive system would destroy the active ingredient.
How it works
Humira treats a range of auto-immune conditions, including plaque psoriasis.
In an autoimmune disease, the body's immune system falsely detects and attacks a threat within the body that does not really exist.
This can lead to a number of problems and conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and psoriasis.
TNFα triggers inflammation when the body is under threat, and the immune system goes into action to protect it.
However, too much TNFα can attack healthy tissue and cause inflammation. Inflammation can lead to pain.
Humira binds to TNFα and blocks its inflammatory effect. This reduces pain and inflammation in people with autoimmune diseases.
The word HUMIRA stands for HUman Monoclonal Antibody In Rheumatoid Arthritis.
Clinical trials have shown that Humira is effective in treating a range of auto-immune diseases. It has approval for these conditions.
Active ankylosing spondylitis
This is a chronic inflammation of the spine and sacroiliac joints. The patient feels pain and stiffness in and around the area of the spine. Eventually, the chronic inflammation can lead to complete fusion of the vertebrae. The name of this process is ankylosis.
Ankylosing spondylitis sometimes occurs in people with inflammatory bowel disease, such as ulcerative and Crohn's colitis, and psoriasis.
In 2007, an evidence-based review suggested that Humira is effective in treating ankylosing spondylitis. The researchers described its use as "cost-effective."
Moderate to severe chronic plaque psoriasis
Around 80 percent of patients with psoriasis have this type of psoriasis, according to the National Institutes of Health (NIH).
Symptoms include well-defined patches of red raised skin, usually on the trunk, scalp, elbows, knees, and nails, but the patches can appear anywhere on the skin. Scale builds up on top of the plaques.
People with psoriasis have very dry skin that can itch, crack, and be painful.
In July 2016, the Decision Resources Group (DRG) noted that Humira and similar biologics are continuing to gain popularity as a treatment for psoriasis.
Moderate to severe psoriatic arthritis
This condition leads to joint inflammation. The NIH note that joint inflammation affects about 20 percent of people with psoriasis.
Doctors commonly prescribe Humira to treat psoriatic arthritis, but researchers are still investigating the best ways to use it.
A 2015 study suggested that health care providers should tailor the therapy to individual needs. Studies show that when the blood concentration of Humira is between 5 and 8 milligrams (mg), the drug is effective. Outside this range, it does not appear to have benefits.
Moderate to severe Crohn's disease
A health worker will teach the person how to use the drug. Most people will be able to take it at home using a pen or syringe.
This is a chronic condition that causes inflammation of the digestive tract. It can affect any part of the gut, from the mouth to the anus. It usually affects the ileum, or lower part of the small intestine. Symptoms include pain, and their intestines empty frequently, resulting in diarrhea.
Authors of a review published in 2013 stated that "The advent of anti-tumor necrosis factor (TNF) therapies revolutionized the treatment of inflammatory bowel disease."
They concluded that among people with Crohn's disease, Humira was most likely to help those with a moderate condition.
They called for further research into the safety and effectiveness when people use it for longer than a year.
Moderate to severe juvenile idiopathic arthritis
This is an inflammation of one or more joints, and it starts in childhood. Pain is an important symptom, and it often improves during the day.
Moderate to severely active rheumatoid arthritis
Rheumatoid arthritis (RA), or rheumatoid disease, is a chronic, progressive, and disabling autoimmune disease that causes pain and inflammation in the joints, the tissues around the joints, and other organs.
In 2011, researchers observed that biologics have "transformed" the treatment of RA. They comment that while expensive, biologics may be more cost-effective in the long term.
The authors noted:
"Although biologic agents are more costly in the short term than conventional disease-modifying antirheumatic drugs, drug-specific costs may be offset by significant improvements in RA symptoms, slowed disease progression, and improved physical function and quality of life for patients."
Moderate to severe hidradenitis suppurativa
Hidradenitis suppurativa (HS) is a chronic condition that leads to abscesses and scarring on the skin.
It occurs near hair follicles around the sweat glands. It affects about 1 percent of people, according to the National Organization for Rare Diseases (NORD).
It is difficult to manage, but antibiotics may help. In severe cases, immunosuppressant drugs, such as Humira, can help.
Humira is the only systemic, non-corticosteroid drug that has FDA approval to treat non-infectious uveitis, an inflammation that affects the central part of the eye. Corticosteroids help relieve symptoms, but they can have severe adverse effects.
Biologics are promising as a treatment, and they offer targeted therapy, according to an article published by the American Academy of Ophthalmology.
However, there is also a chance of adverse effects with these drugs, including a higher risk of infection.
How to take it
Humira is a long-term treatment. Patients respond at different speeds to its analgesic and anti-inflammatory effects.
According to the manufacturer, Abbvie, some people see benefits after 2 weeks, while others may need to take it for 3 months or longer to see an improvement.
The individual must adhere to the treatment plan for best results. Those who stop taking their medications are most likely to have overactive immune systems again.
How to use the Humira pen or syringe
The manufacturer, Abbvie, recommend injecting Humira into either the abdomen or the thighs, using a prefilled pen or syringe.
The person should not have the injection in skin that is bruised or tender, or where there are patches of psoriasis.
People normally administer Humira themselves. A single-use pen contains 40 mg of medication. A syringe may contain 40, 20, or 10 mg.
Humira use begins with a starting dose. After this, a person will have regular doses, normally every second week. A doctor will advise on dosage requirements.
There are specific instructions for storage and use. Before use, a doctor must show the individual how to use the Humira pen or syringe, and the user should read the full instructions.
The user should practice first with a health care professional, to ensure the click of the pen does not startle them when they take the dose.
Breathing difficulties could indicate an adverse reaction, and the person should contact their doctor.
Humira can have a number of adverse effects.
As it is an immunosuppressant, the body will be more prone to infections when a person is using it.
Researchers have also found links between TNF blockers and cancer, including some rare and unusual types of cancer.
Common adverse effects include the following, but these are not the only ones:
- redness, rash, swelling, itching or bruising at the injection site
- infections, especially in the upper respiratory tract and sinuses
- headaches and nausea
Some serious side effects require immediate medical attention.
Infections that can occur include tuberculosis (TB) and other infections caused by viruses, fungi, or bacteria. These can be serious.
Infections may develop in carriers of hepatitis B. Symptoms include fever and chills, muscle pain, fatigue, dark urine and a yellow tinge to the eyes of skin, loss of appetite, vomiting, clay-colored feces, stomach problems, and skin rash.
Allergic reactions affect some people. Symptoms include chest tightness, wheezing, and other breathing difficulties, hives, itching, and skin rash, swelling of the tongue, lips, face and other parts of the body.
Nervous system problems may occur, leading to weakness in the arms and legs, numbness, tingling, visual disturbances, and dizziness.
Blood problems may occur. A low platelet count can lead to a higher risk of bleeding, and a low level of white blood cells make it harder to fight infection. The person may have a fever that does not go away, or they may bruise or bleed easily.
Heart conditions can develop or get worse, leading to shortness of breath, sudden weight gain, and swelling in the hands and feet.
Immune reactions are possible. One example is a lupus-like syndrome, with chest pain and shortness of breath, joint pain, or a rash on the cheeks or arms that worsens when exposed to the sun.
Liver problems can arise, leading to fatigue, yellowish skin or eyes, vomiting and not wanting to eat, and abdominal pain.
Psoriasis may emerge or worsen.
Patients should not take Humira if they have an allergy to any medication containing adalimumab or Mannitol, sodium citrate, monobasic sodium phosphate dihydrate, sodium chloride, citric acid monohydrate, or polysorbate 80.
Humira is not suitable for anyone with a severe infection, active TB, and other infections that may occur when the immune system has weakened.
People should not take it with a number of drugs, including Kineret (anakinra) and Orencia (abatacept). It is important to tell the doctor about any other medications or supplements that you are using.
Before using Humira, the person should ensure their doctor knows if they have or have ever had any of the medical conditions listed below:
- any type of infection, including a localized one, such as a leg ulcer
- a fungal infection
- allergy to latex or rubber
- any heart condition
- any type of autoimmune disease
- any type of demyelinating disease, including multiple sclerosis
- liver or kidney problems
- recurrent infections, or any conditions which increase infection risk
The doctor also needs to know if the person is taking any immunosuppressant medications, if they or anyone close to them has, or has had, tuberculosis (TB), and if the person is a carrier of the hepatitis B virus.
Some people may be able to get help with Humira from their insurance company. This link can provide more information.
Other products that work in a similar way, known as biosimilars, will become available in time.
In September 2016, Amjevita gained the approval of the United States Food and Drug Administration (FDA) but due to patent litigation has not yet reached the market.
The FDA note that Amjevita can also help in cases of moderately to severely active polyarticular juvenile idiopathic arthritis from the age of 4 years.