What do monoclonal antibody drugs do?
Christiane Fux studied journalism and psychology in Hamburg. The experienced medical editor has been writing magazine articles, news and factual texts on all conceivable health topics since 2001. In addition to her work for, Christiane Fux is also active in prose. Her first crime novel was published in 2012, and she also writes, designs and publishes her own crime plays.
More posts by Christiane Fux All content is checked by medical journalists.Health Minister Jens Spahn (CDU) has ordered two new types of Covid-19 drugs on a large scale. They contain so-called monoclonal antibodies, which are supposed to help the body fight the virus. However, they are not yet approved in this country. However, they can be used within the framework of exceptional regulations. How effective are the drugs - and who should get them?
Spahn took over 400 million euros for the 200,000 units. The drugs are to be used practically immediately in selected university clinics in Germany, the health minister explained to "Bild am Sonntag". They should be given to patients who are at a particularly high risk of severe disease.
What are the drugs?
The drugs are "Bamlanivimab" from the US pharmaceutical company Eli Lilly and "Casirivimab / Imdevimab" from the US pharmaceutical company Regeneron Pharmaceuticals. The former contains one, the latter two monoclonal antibodies. Both drugs are given by infusion.
The then US President Donald Trump had already received casirivimab / imdevimab in early October as part of his Covid 19 illness. In November 2020, both active ingredients received emergency approval in the USA. No approval has yet been applied for in the EU market.
How do monoclonal antibodies work?
Monoclonal antibodies are produced in the laboratory. They are supposed to work in basically the same way as antibodies that the body makes itself to fight off the virus. An antibody formed by a patient, which had proven to be particularly effective, then also served as the construction template for the monoclonal antibodies. Like their natural templates, monoclonal antibodies attach to the virus and prevent it from penetrating the body's cells and multiplying.
Only useful at the beginning of the illness!
The administration of these antibodies only makes sense in the early phase of the infection, when the immune system has not yet produced any antibodies. Then they should slow down the replication of the virus in the body in good time and thus prevent a severe course.
If the infection is more advanced, these drugs will no longer help: the damage to the organs has already occurred. The main danger then often comes from the overactivated immune system itself. So you can't save the life of seriously ill people with it.
In addition, in patients who receive oxygen or have to be ventilated, the antibodies could even worsen the course of the disease, warns the U.S. American Food and Drug Administration (FDA).
Since the funds are complex to produce and very expensive, it is by no means possible to provide comprehensive care for all risk patients. The pandemic will not lose its horror on the basis of these drugs.
How effective are the drugs?
Overall, the data situation for the two drugs is still very thin in view of the limited number of study participants. Possible side effects are also far from being conclusively assessed. The FDA's findings were nevertheless sufficient for an emergency approval in the USA in November 2020.
According to a study by the manufacturer Eli Lilly with 469 patients with no or only mild symptoms, 3 percent had to be treated in an emergency room or hospital after an early dose of Bamlanivimab. In the placebo group, it was 10 percent. The preparation also worked in older people: In the group of over 65-year-olds, 4 percent had to be treated in intensive care. In the placebo group, it was 15 percent.
According to the manufacturer Regeneron Pharmaceuticals, the drug "Casirivimab / Imdevimab" has a similar effect. Of the 799 high-risk patients who were symptom-free or had had symptoms for a maximum of seven days, 3 percent later had to be treated in a clinic or an emergency room. In the placebo group, the proportion of those infected who later had to be hospitalized was 9 percent.
This means that if one hundred high-risk patients receive one of the drugs, six ("Casirivimab / Imdevimab") or seven (Bamlanivimab) severe courses can be prevented.
What do you know about side effects?
According to a clinical study, the antibody combination casirivimab / imdevimabtraten did not occur more frequently than in a control group. According to the FDA, the researchers observed more severe side effects in two of 850 cases with Eli Lilly's bamlanivimab. Since both agents are still in the test phase, less common side effects may not have been noticed so far. Even occasional severe hypersensitivity reactions cannot be ruled out.
Who will receive the medication?
The drugs are intended to be given to infected adults and children from 12 years of age (body weight at least 40 kg) who are at high risk of a severe course. According to the manufacturer, this includes
- all persons aged 65 and over,
- all persons aged 55 and over if they suffer from cardiovascular disease, high blood pressure, COPD or other chronic respiratory diseases,
- obese people of all ages with a body mass index (BMI) of 35 or more,
- Patients with chronic kidney disease,
- Diabetic,
- People with immune deficiency,
- Patients taking immunosuppressive drugs.
According to the Federal Ministry of Health (BMG), the application is based on an individual risk-benefit assessment by the treating physician.
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