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Infusion (symbol picture): The treatment with the antibody means takes around two hours
Photo: imago images
Monoclonal antibodies probably got their greatest fame through Donald Trump.
After being treated with a cocktail of artificial antibodies for his Covid-19 illness, he said all Americans should receive this therapy.
It is not a therapeutic agent, but a remedy.
It was already clear then that Trump was massively exaggerating.
Nonetheless, monoclonal antibodies are among the few drugs to date that specifically fight the coronavirus.
At the weekend, Health Minister Jens Spahn announced in »Bild« that he had secured 200,000 doses of the funds for Germany - despite the lack of approval.
Selected clinics expect the first delivery at the beginning of next week.
But what do the expensive drugs do?
Who can you help?
And where are their limits?
The overview.
What are monoclonal antibodies?
In the meantime, several pharmaceutical companies have developed monoclonal antibodies that are supposed to help Covid-19 sufferers.
The approach is always the same: Researchers use a natural antibody as a model, for example from someone who has recovered from corona, decode it in the laboratory and then reproduce it in large quantities.
"The drugs are nothing more than neutralizing antibodies, like those developed by the immune system in the event of an infection, only that they have been artificially produced," says Clemens Wendtner, chief physician of infectious diseases at Munich Clinic Schwabing.
Neutralizing antibodies prevent the coronavirus from entering cells and multiplying.
Anyone who has a lot of neutralizing antibodies from a vaccination or illness is immune.
What exactly did Germany order?
Specifically, the federal government has ordered two corona antibody drugs for which there is already an emergency approval in the USA:
the antibody Bamlanivimab from Eli Lilly and
the antibodies casirivimab / imdevimab from Regeneron, which are administered together.
So far, neither of the two agents has been approved in the EU.
For which patients are antibody drugs suitable?
According to the current state of knowledge, the drugs only help if they are used very early - preferably within the first days after the test or the onset of symptoms.
The aim is to support the immune system in fighting the virus and thereby prevent a serious course of the disease.
"If the patient has formed their own antibodies after 10 or 14 days, the drugs are no longer effective," says Wendtner.
In addition, antibodies against inflammation or other consequences of the infection cannot do anything.
"You can compare it to a burning bale of straw," says Wendtner.
“If he's coking something, it still makes sense to pour a bucket of water on it.
As soon as it burns brightly, it's too late for that. "
The emergency approvals in the USA are also limited to use in patients with mild to moderate Covid 19 disease who are at high risk of a severe course - but who are still at home at the time of therapy.
How effective are the drugs really?
“The drugs could be another building block in fighting the pandemic.
But we do not expect the ultimate savior, ”says Marylyn Addo, head of the Infectious Diseases Section at the University Medical Center Hamburg-Eppendorf (UKE).
So far, the results of two studies by the companies Regeneron and Eli Lilly, in which patients were treated at the beginning of their illness, are known.
"The primary aim of these investigations was actually to prove that the drugs significantly reduce the viral load," says Wendtner.
"That didn't work."
Instead, the companies evaluated how many people became so seriously ill within 28 days of being treated with the artificial antibodies that they had to go to a clinic.
In this evaluation, the drugs showed advantages; treatment with a placebo was used as a comparison:
With the Eli Lilly drug, only three percent instead of ten percent of those affected had to go to a clinic compared to the placebo group.
The Regeneron cocktail achieved similar values, with three percent instead of nine percent of those affected having to go to hospital after treatment compared to placebo therapy.
“The hospitalization rate is a somewhat subjective criterion,” says Wendtner.
Whether a patient comes to the hospital or not can also depend on the attending physician, on the wishes of the sick person or on the available capacities.
Apart from that, studies are still ongoing to find out whether patients who have already been admitted to the hospital need to be transferred to the intensive care unit less often if they have been treated with artificial antibodies.
The results are still pending.
At least in the case of seriously ill people, it seems clear that the remedies will not help.
Both Eli Lilly and Regeneron have discontinued such investigations because there was no evidence of effectiveness.
Who will be the first to receive the medication in Germany?
Initially, the funds will only be made available free of charge to selected clinics, including the UKE in Hamburg and the Munich Clinic, where Clemens Wendtner works.
"The great art will be to reach patients at such an early stage of the disease," says Wendtner.
"Actually, we should treat them at a time when they are usually not yet in the clinic."
From the medical practitioner's point of view, it is conceivable, for example, to treat patients who come to the clinic because of a stroke or other illness and who happen to test positive for Sars-CoV-2.
"Another scenario would be to treat clinic employees who, for example, have a higher risk of a severe course due to diabetes or being very overweight and who, for example, tested positive as part of an outbreak in the clinic," says Wendtner.
If the medication proves itself, the doctor assumes that the medication will also be used in the outpatient area.
Then, however, there are new, very practical challenges: Antibody drugs are administered by infusion, Wendtner speaks of two hours of pure treatment time.
According to the Infection Protection Act, the fact that infected people come to a family doctor's practice for this therapy can hardly be implemented.
"To do this, the patients would have to be picked up and brought back in a special infection vehicle, and they would have to be isolated and treated in the practice, taking appropriate precautionary measures," says Wendtner.
It is conceivable, however, that doctors would treat those who tested positively on site in the event of an outbreak in a nursing home, also to relieve the clinics.
What are the risks of the funds?
As with any medical treatment, there is a risk of side effects with monoclonal antibodies.
For example, according to the American FDA, the antibodies from Regeneron can trigger an anaphylactic shock, i.e. a severe allergic reaction.
Fever, chills and itching or reddening of the puncture site are also possible.
The means are expensive - or are they cheap compared to intensive treatment?
The production of monoclonal antibodies is complex, for this reason they are also very expensive.
According to Spahn's statements in the “Bild am Sonntag”, the federal government paid 400 million euros for 200,000 doses of funds - so a dose costs an average of 2000 euros.
Two treatments are usually necessary per person.
Should it actually succeed in averting a difficult course and a hospital admission or treatment in the intensive care unit, the therapy would still pay off - in addition to the enormous individual benefit for those affected.
According to a current evaluation by the AOK, caring for a Covid patient in the hospital costs an average of 11,400 euros.
If the sick have to be ventilated, the expenses of the health insurance are on average 41,300 euros.
What amounts of funds are initially available?
The 200,000 cans have been ordered, but have yet to be delivered.
Wendtner assumes that his clinic will receive the first delivery at the beginning of next week, initially 100 cans.
"But that's not bad at all for the start, especially because there is only a very short time window in the context of the illness in which the therapy makes sense," he says.
The drugs are not yet approved in the EU.
What does that mean?
Usually, the benefits and risks of drugs are rigorously reviewed in studies before they are approved and placed on the market.
In exceptional situations, however, the Medicines Act allows physicians to use medicines outside of the approval at their own discretion.
"The doctor is then fully liable," says Wendtner.
“That is not without the means.
There have already been intolerance reactions up to anaphylaxis «.
This is a severe allergic reaction that can be life-threatening, but can also be treated well if the doctors intervene quickly.
It is part of the standard to inform patients about it, says Wendtner.
They then also signed a corresponding declaration.
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