Infliximab

What is infliximab?

Infliximab is a monoclonal antibody. It is a very potent drug that suppresses the immune system and is anti-inflammatory.

It is used for various rheumatic diseases, chronic inflammatory bowel diseases and the skin disease psoriasis. It can only be administered as an intravenous infusion, which is why infliximab must be administered in day clinics or in an inpatient setting. Infliximab has been approved in the European Union under the trade name Remicade® since 1999. Infliximab is covered by health insurers if the indication for therapy with infliximab is given.

What are biologics actually?

Biologics are drugs that are very similar to the body's own natural structures. This allows them to intervene very effectively and purposefully in the processes of the immune system and thus fight diseases.

For this reason, they are also called "biological drugs", the term "biologics" is derived from the English word "biologicals". Most biologics are supposed to imitate certain protein structures. These are called antibodies. Infliximab, for example, is a monoclonal antibody against tumor necrosis factor-alpha, an important mediator in the immune system.

Under which trade names is infliximab on the market in Germany?

The first Infliximab preparation was offered on the market in Germany under the trade name Remicade®.

For many years, this preparation from MSD was the only one available. A biosimilar was only approved in Germany in 2013. Biosimilars are copycat products that can only be produced and sold when the patent on the original product has expired. Infliximab came to pharmacies in 2013 under two other trade names: as Inflectra® from Hospira and Remsima® from the pharmaceutical company Celltrion. They have the same effect as the original Remicade®. In 2016, another biosimilar was released for the German market. The company Samsung Bioepis sells it under the trade name Flixabi®. It is likely that other pharmaceutical companies will develop infliximab biosimilars as well.

Indications for infliximab

Indications are reasons for using a drug. Infliximab is a Immunosuppressant, so suppresses the immune system. It can therefore be used for various inflammatory diseases.

In Germany, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis represent an indication from the rheumatic group of forms. It is also used in chronic inflammatory bowel diseases such as Crohn's disease and ulcerative colitis. Finally, psoriasis is also an indication for therapy with infliximab.

Read more about the topic here:

• Immunosuppressants
• Therapy of Crohn's disease

Infliximab in Crohn's disease

The first area of ​​application for infliximab was Crohn's disease and the drug is still approved as a therapy for this chronic inflammatory bowel disease.

However, the therapy concept for Crohn's disease is structured like a ladder. So you start with basic therapeutic agents that are more tolerable and have fewer side effects. These include, for example, locally acting glucocorticoids. If these no longer work or if an acute attack occurs, the next stage of therapy is passed. Only at the bottom of this ladder are immunosuppressants such as infliximab. It is also used especially in young patients, who can usually tolerate such a strong inhibition of the immune system a little better than older people.

This article might also interest you: Therapy of Crohn's disease

Infliximab for ulcerative colitis

Infliximab is also used in ulcerative colitis. Indications for use are moderate to severe relapses in adults; it is very rarely used in children.

It can also be administered if no other medication is addressed, therapy with glucocorticoids or other immunosuppressants has been unsuccessful, or there are contraindications for other therapeutic measures. These include allergies or side effects that could adversely affect the rest of the patient's health.

More information can be found here: Therapy of ulcerative colitis

How does infliximab work?

Infliximab is a monoclonal antibody that is manufactured using biotechnology. Monoclonal means that all antibodies contained in the preparation are exactly the same, as they were synthesized by one and the same cell. As a result, infliximab has a very high affinity for its target structure, the human, i.e. human, Tumor necrosis factor-alpha. Tumor necrosis factor alpha is an inflammatory mediator in the immune system. This means that it triggers and supports various processes in the body that cause inflammatory reactions. Usually it helps the immune system keep the body healthy. However, it can happen that tumor necrosis factor-alpha is directed against the body's own cells and components. Why exactly he does this is not yet fully understood.

This process in which the body attacks itself is also known as an autoimmune disease. Such autoimmune diseases include rheumatic diseases and Crohn's disease, for example. Infliximab is specially designed to do the Tumor necrosis factor can intercept and thus render harmless. The result is that it can no longer attack its own body. However, as mentioned, the Tumor necrosis factor-alpha but also useful functions that are also lost if it is destroyed by infliximab. The entire, sometimes useful, immune system is inhibited, which is why infliximab is also referred to as an immunosuppressant, i.e. immune system suppressor.

This article might also interest you: What is an autoimmune disease?

Side effects of infliximab

Side effects occur in addition to the actual desired effect of a drug and can have harmful consequences for the body. Infliximab is a very powerful drug that has a massive impact on the immune system. It therefore has many side effects. Very commonly, viral infections such as upper respiratory tract and nose, headache and pain when giving the infusion can occur. The term "very common" is precisely defined and means that more than one in ten people have this side effect.

Common side effects, reported by more than one in 100 people, are bacterial infections, changes in blood composition, allergic reactions in the airways, depression, insomnia, dizziness, loss of sensation, palpitations, racing heart or conjunctivitis. Occasionally, fungal infections, systemic allergic reactions, confusion, nervousness, seizures, eyelid edema and cardiac arrhythmias occur. By definition, in one in 1000 patients.

Meningitis, anemia, anaphylactic reactions, temporary loss of vision or cyanosis have been described rarely to very rarely (one in 10,000).

Infliximab interactions

Interactions between infliximab and other drugs taken at the same time are possible. Although there have not been many studies on interactions with infliximab, it is recommended that certain aspects be considered when using it.

Infliximab should not be taken with drugs that have a similar effect, as they can mutually intensify their effects and serious infections can occur. Live vaccines should not be administered for the duration of the therapy, as they put a lot of strain on the immune system and this is already weakened due to the immunosuppression.

When should infliximab not be given?

There are a number of contraindications that infliximab should not be given. In general, caution should be exercised if you have had an allergic reaction to infliximab or a similar immunosuppressive drug in the past. In this case, there is a significantly increased likelihood of a second, more severe allergic reaction.

Infliximab should not be given in patients who have had or currently have tuberculosis. The same applies to other severe or acute infections. Another contra-sign is the presence of moderate to severe heart failure.

How is infliximab dosed?

No precise information on the dosage can be given in general. It depends very much on the underlying disease, the extent of the disease and the age of the patient. In children, the dose is calculated strictly according to body weight. Infliximab is given at intervals. That means it is not administered daily. It is usually given twice over a short period of time at the beginning of the therapy, after which the interval between the doses is extended to four to six weeks. This is possible because infliximab has a very long duration of action.

Why is the cost of infliximab so high?

The cost of infliximab is so high because developing the drug used up a lot of resources and took a long time. In addition, as it is now, it was an extremely complex manufacturing process. Since infliximab is a highly specific and very effective drug, a lot of damage can be done if it is not manufactured, stored and processed extremely correctly. These are all factors that drive up costs. Before the biosimilars, the copycat products, were launched on the market, the drug was even more expensive because it was patented and could not be produced by any other company. As a result, there was no competition that could have reduced the development costs.

What alternatives are there to infliximab?

In addition to infliximab, there are other tumor necrosis factor alpha inhibitors that can be used depending on the underlying disease and current health situation.

An alternative is the antibody adalimumab, which is marketed under the trade name Humira®. There are also the drugs certolizumab (Cimzia®), etanercept (Enbrel®) and golilumab (Simponi®). They are all monoclonal antibodies that suppress the immune system. However, they partly differ in their form of administration, the way in which they are administered, the dosage and in their precise chemical properties. For example, some stay in the blood a little longer than others. However, because they have the same effect, they also have similar side effects, contraindications, and indications.

Inliximab and alcohol - are they compatible?

There are no explicit recommendations as to whether alcohol should be avoided during therapy with infliximab. In general, however, it is always recommended to drink as little alcohol as possible when taking medication. Alcohol weakens the human body, stresses the liver and leads to changes in thinking and perception. Infliximab itself can cause such symptoms as a side effect. Therefore, these two substances should only be taken together with caution.

Can it be taken during pregnancy and breastfeeding?

It is not possible to take infliximab during pregnancy or while breastfeeding. There are no clear studies that would show that infliximab would harm pregnant women or their babies. However, there are some indications and general biological processes that suggest that the active ingredient can get into the child's circulation and cause damage there. Six months after the mother had taken the drug, infliximab was found in the child's blood. It is still unclear what health consequences this could have for the child.

Can I take infliximab and the pill at the same time?

Infliximab and the pill can be taken together. The pill usually works despite the strong immunosuppressive drug. However, if other glucocorticoids or immunosuppressants were used before treatment with infliximab, it must be carefully checked whether contraception with the pill alone is still possible. To do this, it is advisable to consult the attending physician or a gynecologist.