Humira
introduction
Humira is the trade name for the biological adalimumab, which is used to treat rheumatoid arthritis and other rheumatic diseases, psoriasis and inflammatory bowel disease, for example.
It is injected under the skin of the abdomen every two weeks. In addition to its wide range of applications, its price is also remarkable: one application costs around € 1000. This makes it one of the most expensive drugs on the German market.
What is Humira?
Humira or its active ingredient adalimumab is a so-called monoclonal antibody.
Antibodies are proteins that are produced by the immune system in order to recognize and fight off invaders such as bacteria and viruses. Monoclonal means that the antibody is derived from a single cell line and is only directed against a certain "hostile" structure. In contrast to this, an antibody produced by the immune reaction in the human body is always directed against various characteristics. The "-mab" at the end of the name indicates that it stands for the English "monoclonal antibody". Humira targets the so-called tumor necrosis factor alpha (TNF-α), which plays an important role in the inflammatory response in humans. Humira thus inhibits an excessive inflammatory reaction.
What are biologics actually?
Biologics are a very new group of drugs that mimick the molecules found in the human body and are produced biotechnologically by genetically modified organisms. On the one hand, proteins (for example monoclonal antibodies, hormones or vaccines) and nucleic acids are produced; these are the building blocks of DNA.
Since the biologics are based on the molecules that already exist in the body, they intervene very specifically in the processes in the body and are becoming increasingly important due to the possibility of solving very specific problems with them.
Indications for Humira
Humira inhibits excessive immune reactions of the body and is used to treat such: It is used in chronic inflammatory bowel diseases such as Crohn's disease and ulcerative colitis, in many diseases from the rheumatic type, psoriasis, acne inversa and non-infectious inflammation of the middle eye skin (Uveitis). As a rule, Humira is only used for moderate to severe illness and usually only when other therapeutic approaches have failed.
in Crohn's disease
Patients with Crohn's disease suffer from episodes of stomach and intestinal problems caused by inflammation of the gastrointestinal tract that penetrates the organ wall. A distinction is made between therapy in the acute episode and therapy to prevent the occurrence of a flare-up. TNF-α blockers like Humira are used both to prevent a new flare-up and to treat a particularly severe acute flare-up. Studies have also shown that it is effective in improving symptoms.
in ulcerative colitis
Similar to Crohn's disease, ulcerative colitis is a relapsing chronic inflammatory bowel disease that particularly affects the large intestine. TNF-α blockers such as Humira can also be used for ulcerative colitis, but mostly only after the standard therapy has failed or is no longer tolerated. Since there is usually a well-tolerated standard therapy for ulcerative colitis and, even in the worst case, surgical removal of the large intestine is available as a curative option, the use of biologics, some of which have very side effects, is less justifiable here than with Crohn's disease, which is more difficult to treat.
with uveitis
Non-infectious uveitis is an inflammation of the middle skin of the eye, which can occur in association with various diseases, among other things; these include chronic inflammatory bowel diseases, rheumatic joint diseases such as Bechterew disease and rheumatoid arthritis or sarcoid.
Such uveitis, which is not directly triggered by a pathogen such as viruses or bacteria, can also be treated with the help of Humira, since this is also an excessive inflammatory reaction. Here, too, Humira is not a first-line therapy; other drugs such as cortisone are initially used.
Active ingredient and effect
As mentioned above, adalimumab is an antibody against the inflammatory tumor necrosis factor alpha (TNF-α). The TNF-α causes the body to release many other inflammatory messenger substances; you could say it fuels the inflammation. It is therefore increased in the blood in many diseases which are accompanied by an excessive inflammatory reaction. Humira binds to TNF-α, which is then inactivated and broken down. This leads to an anti-inflammatory effect and an improvement in the symptoms. Since Humira is an antibody, it would be broken down in the stomach and is therefore not administered orally, but usually as an injection under the skin of the abdomen. It can take a while for it to pass completely into the bloodstream, so the maximum effect only occurs after a few days.
Side effects
Humira can cause a wide range of side effects, but here are just the most common:
More than one in ten users experience allergic reactions; usually a local reaction with redness, swelling and itching. More rarely, the allergic reaction can range up to a manifest allergic shock with shortness of breath, swelling of the face, hands or feet, rash all over the body and a racing heart. In the event of a severe allergic reaction, a doctor should be informed immediately.
In addition, more than 1 in 10 users may experience respiratory infections, headache or abdominal pain, nausea and vomiting, skin rashes, or muscle or bone pain.
Since Humira weakens the immune system, infections with viruses, bacteria or fungi, for example of the ears, skin or genital organs, often occur during treatment with it. In the worst case, these infections can turn into life-threatening blood poisoning. Furthermore, changes in the blood count, mood changes and sleep disorders, benign tumors and skin tumors, kidney problems and problems of the cardiovascular system can often occur. Since a large number of other side effects are possible, please refer to the package insert. If you are unsure whether a complaint could be a side effect of Humira, a doctor or pharmacist should be consulted.
Weight gain
Weight gain in the sense of an increase in body fat has not been observed with the use of Humira. However, Humira can lead to water retention in various parts of the body. Such water retention is then also very quickly noticeable on the scales; the fluctuations in weight can be faster and greater here than with an increase or decrease in fat or muscle mass.
depression
One in ten people who are treated with Humira will have mood swings. This can also manifest itself as depression. If signs of depression occur while using Humira, the attending physician should be consulted.
Hair loss
One in ten people may experience hair loss while taking Humira. This can happen without a medical history of skin or hair disorders or, for example, due to existing psoriasis, which can get worse with Humira. If these side effects occur, it is advisable to ask your doctor for advice at an early stage.
Interactions
Humira is often used in combination with cortisone, with methotrexate, which is also immune-inhibiting, or in combination with other specified drugs with a similar effect.
The active ingredients etanacept, abatacept and anakinra are an exception here, among which, in combination with Humira, severe infections and increased side effects have been demonstrated.
Over-the-counter pain relievers such as aspirin or ibuprofen can be used with Humira without any problems.
If there are any doubts about a combination of drugs, a doctor or pharmacist should be consulted.
Are Humira and alcohol compatible?
As a rule, drinking alcohol with the use of Humira should be tolerable. Humira is a medicine that is injected under the skin. It is therefore little affected by foods ingested through the gastrointestinal tract, including alcohol. In addition, Humira only reaches its maximum effective level in the blood after about 5 days. If you wanted to be on the safe side, you can avoid alcohol on this day. Caution should be exercised if liver function tests have deteriorated or if the liver has active disease from taking Humira.
When should Humira not be given?
Humira should not be used if there is a known allergy or hypersensitivity to adalimumab. In addition, because Humira works by blocking the body's immune system, Humira must not be used if there is an existing infection; this applies particularly to active tuberculosis.
People with mild heart failure or multiple sclerosis can have Humira under close supervision by a doctor.
So far there are no data on the use in pregnant and breastfeeding women or in people with liver and kidney damage; therefore, its use is not recommended.
dosage
The standard dose of Humira in adults is 40 mg once every two weeks. The drug is injected under the skin of the abdomen.
In children and adolescents, the dose depends on their height and weight and is determined by the doctor concerned before starting treatment.
For psoriasis, non-infectious uveitis and Crohn's disease, adults start with double the dose, i.e. 80 mg, and then continue treatment with 40 mg every two weeks.
In ulcerative colitis, particularly severe Crohn's disease and acne inversa, the starting dose is even started with 160 mg and then reduced.
If the single dose is higher than 40mg, it is injected in stages: with 80mg in two single doses within one day, with 160mg either as four single doses within one day or two 40mg doses on two consecutive days. The standard interval between two doses is two weeks, but the doctor can shorten it to one week if necessary.
Why is the cost so high?
As explained above, Humira is a biological, i.e. a drug that is produced biotechnologically with the help of genetically modified organisms. In the case of Humira, these are so-called CHO cells (chinese hamster ovaries). This means that the egg cells of the Chinese hamster are used to produce the antibody adalimumab. As you can imagine, this is a very complex process and accordingly costs a lot of money.
Alternatives to Humira
Usually, before using Humira, other medications, called basic therapeutics, such as cortisone, 5-ASA or methotrexate are tried. Depending on the disease, very different drugs can be used. As an alternative to Humira, some other biologics can also be used. Particular mention should be made of other TNF-alpha blockers, such as infliximab, which is sold under the trade name Remicade, or Etanacept, which is sold under the name Enbrel.
Can it be taken during pregnancy and breastfeeding?
There are no data yet on the use of Humira during pregnancy. Therefore, pregnant women are advised not to use Humira in order not to endanger the child. If Humira is accidentally used, a doctor should be informed, as the baby may be at greater risk of developing an infection and may need a vaccination. It is also unclear whether Humira passes into breast milk. Since Humira stays in the body for a long time, you should not breast-feed for at least five months after the last use.
Humira and the desire to have children
The possibility of having a child is in principle not influenced by Humira. However, it could become problematic if high levels of Humira are still present in the blood at the beginning of pregnancy. Therefore, if you are trying to have children, the advising gynecologist, the doctor who prescribed the Humira or a pharmacist should be consulted when using Humira.
Can Humira be used at the same time as the pill?
Humira and birth control pills should not normally get in each other's way, as they are used in a completely different way and they work in very different places in the body. Nevertheless, it can certainly do no harm to inform the prescribing doctor about the use of the respective medication.
