Treatment > Medications

Humira - antibody therapy

Dr. med. Andre Sommer

Dr. med. Andre Sommer

Humira is a drug from the pharmaceutical company AbbVie. It contains the active ingredient adalimumab, Adalimumab belongs to the group of so-called biologicals. These are recombinantly produced antibody **that interfere with immunological processes in the body. This mode of action makes Humira suitable for use with **autoimmune diseases. In addition to inflammatory bowel diseases (Crohn's disease or ulcerative colitis), these include inflammatory rheumatic diseases and psoriasis. Adalimumab is an antibody against the tumor necrosis factor-alpha involved in inflammatory processes (TNF-alpha). Since antibody therapy is still a relative new form of therapy, it is still very expensive. The therapy is therefore often only used when conventional therapy methods do not achieve the desired effect.

How is Humira administered?

The active substance adalimumab is available as an injection in Humira. This is directly offered as pre-filled syringe or **pen **packaged in a consumer-friendly way. The drug is regularly injected subcutaneously (under the skin) with the pen or syringe. Humira is available in different dosages. Each syringe contains 20, 40 or 80 milligrams of adalimumab. AbbVie has its own product on the market for children and teenagers. The solution for injection for children and adolescents is drawn up in an enclosed syringe. This allows the amount to be dosed individually.

For the exact way of using the syringe and pen, please read the package leaflet in detail. The individual steps are described there from disinfecting the skin (mostly the belly) to administering the medication to disposal of the needle.. At the start of therapy, the medicine is usually injected by your doctor. The doctor will then show you how to use the syringe yourself. But take as much time and practice as you need!

You can administer Humira yourself as a pre-filled syringe or injection pen subcutaneously

What are the side effects of Humira?

When using the** TNF-alpha** antibody **there may be side effects. TNF-alpha is an important signaling molecule of the immune system. Therefore Humira and its **TNF-alpha antibody strongly intervene in the body's immune system. The function of the immune system is inhibited. On the one hand, this is desired in order to prevent an autoimmune reaction. Because this reaction causes the symptoms of the disease. At the same time, it makes the body more vulnerable to a variety of pathogens.

The possible side effects are varied, but do not occur in all patients. You can find more detailed information about the side effects of Humira in our blog posts. If there are signs of an allergic reaction, you should definitely notify a doctor!

Many sufferers worry that Humira therapy will lead to a weight increase. This side effect was not observed in the approval study.

Side effects where you need to notify a doctor immediately:
Severe rash, hives, allergic reactions
Swelling of the face, hands, or feet
Difficulty breathing or swallowing
Shortness of breath when stressed or lying down, swelling of the feet

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What does therapy with Humira look like?

Together with your treating doctor, have you opted for therapy with the TNF-alpha antibody? In order to be properly informed, it is important to get a good explanation from your doctor. The information presented below should support you. In no case, does it replace a consultation with your doctor. Humira is a prescription drug and must be prescribed by a doctor. Before you inject Humira for the first time, you should definitely evaluate your risk profile with a doctor. You should definitely inform your doctor in detail about your previous illnesses. Infectious diseases such as hepatitis B or tuberculosis, but also diseases of the heart, are of particular importance.

Dosage

The** dosage** of Humira depends on the clinical picture (rheumatoid arthritis, ulcerative colitis, Crohn's disease). Therefore, no general recommendation can be given. The table lists typical applications. After a high starting dose with the first injection, Humira is then injected in lower doses every two weeks. In order to get a faster onset of action, the doctor can double the starting dose in special cases. If the desired effect is not achieved, the doctor can order a weekly intake. You should therefore discuss the dosage exactly with your doctor. The information in the table relates to adults.

Illness Dosage
Crohn's disease Initial dose: 80 mg 1. Syringe

Ongoing dosage: 40 mg every two weeks

Ulcerative colitis Initial dose: 160 mg 1. Syringe

2. Syringe: 80 mg

Ongoing dosage: 40 mg

Plaque psoriasis Initial dose: 80 mg 1. Syringe

Ongoing dosage: 40 mg every two weeks (starting one week after the initial dose)

Acne Inversa Initial dose: 160 mg

2. Syringe after two weeks: 80 mg continuous therapy: 40 mg

Starts two weeks later and then continues weekly

Non-infectious uveitis Starting dose: one 80 mg injection

Ongoing dosage: 40 mg every two weeks starting one week after the starting dose

What are biosimilars?

Humira is the drug name of the first product of a TNF-alpha antibody. Patent protection is available worldwide for newly developed drugs: The drug must not be copied by other pharmaceutical companies. To cover the high costs that are required for innovative research and numerous impact studies, these original drugs are very expensive.

Subsequent preparations of** biopharmaceuticals** like adalimumab are biosimilars. The active substance in biosimilars is comparable to the active substance of the already approved drug. To be approved on the market, biosimilars must pass the approval process of the European Medicines Agency (EMA). Various** pharmaceutical companies** like Amgen and Samsung Bioepis have already successfully gone through this process. The same applies to the drug Cyltezo by Böhringer Ingelheim. In Europe, Abbira's patent law for Humira expired in October 2018. Other pharmaceutical companies can now bring their own Humira-like products onto the market. Due to the resulting competition, it can be assumed that the costs for TNF-alpha antibodies will drop drastically.

The patent of the American manufacturer for Humira ends in October 2018. Biosimilars will be cheaper on the market in the future.

How much does Humira cost?

Humira is currently one of the most expensive biologics. In online pharmacies, a pack of six syringes costs over five thousand euros. A syringe costs around 880 euros and is usually necessary every two weeks.

Hartmann, P., & Bokemeyer, B. (2017). Anti-TNF-α antibodies in inflammatory bowel disease. PHARMAKON, 5(5), 356-364.

abbvie (2017). Sicherheitsmonoraphie. Accessed online on 11.07.2018 at (https://www.pei.de/SharedDocs/Downloads/vigilanz/schulungsmaterial/Humira-Schulungsmaterial-AerzteVersion-Juli17Sicherheitsmonographie.pdf?__blob=publicationFile&v=3)

Peyrin–Biroulet, L., Deltenre, P., De Suray, N., Branche, J., Sandborn, W.J. and Colombel, J.F., 2008. Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease: meta-analysis of placebo-controlled trials. Clinical Gastroenterology and Hepatology, 6(6), pp.644-653. https://www.sciencedirect.com/science/article/pii/S1542356508002917

Dr. med. Andre Sommer

Dr. med. Andre Sommer

I’m André, a medical doctor from Berlin. Together with a team of medical doctors, nutritionists and data scientists we empower people to understand digestive issues with our app Cara.

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