Is Monoclonal Antibody Therapy Safe
Monoclonal antibody therapy is safe. It was discovered in the mid-1970s and brought to market in the mid-1990s.
Now, there are more than 60 FDA-approved monoclonal antibody treatments for various diseases, including autoimmune diseases, cancer, and other infections, says Dr. Muma. This type of treatment has been a huge breakthrough in healthcare. It has allowed us to very effectively treat severe diseases. With some autoimmune diseases, monoclonal antibody therapy has produced a complete remission when past treatments wouldve never been able to do that.
Eligibility Criteria For Antibody Treatment
Healthcare professionals currently administer monoclonal antibodies via intravenous infusions in specialized medical facilities. As noted in the clinical trials, most of the treatments work most effectively for non-hospitalized patients in the early stages of COVID-19.
Currently, the FDA have authorized treatments for mild-to-moderate COVID-19 in patients at âhigh risk progression to severe disease.â The FDA define this as meeting at least one of the
Newly emerging variants of SARS-CoV-2 â such as the ones that scientists first identified in the United Kingdom, South Africa, and Brazil â may be resistant to some of the currently available antibodies.
What Are The Side Effects Of Monoclonal Antibodies
Monoclonal antibodies can cause side effects, which can differ from person to person. The ones you may have and how they make you feel will depend on many factors, such as how healthy you are before treatment, your type of cancer, how advanced it is, the type of monoclonal antibody you are receiving, and the dose.
Doctors and nurses cannot know for sure when or if side effects will occur or how serious they will be. So, it is important to know which signs to look for and what to do if you start to have problems.
Like most types of immunotherapy, monoclonal antibodies can cause skin reactions at the needle site and flu-like symptoms.
Needle site reactions include:
Monoclonal antibodies can also cause:
- mouth and skin sores that can lead to serious infections
- high blood pressure
- inflammatory lung disease
Monoclonal antibodies can cause mild to severe allergic reactions while you are receiving the drug. In rare cases, the reaction is severe enough to cause death.
Some monoclonal antibodies can also cause capillary leak syndrome. This syndrome causes fluid and proteins to leak out of tiny blood vessels and flow into surrounding tissues, resulting in dangerously low blood pressure. Capillary leak syndrome may lead to multiple organ failure and shock.
Cytokine release syndrome can sometimes occur with monoclonal antibodies, but it is often mild. Cytokines are immune substances that have many different functions in the body, and a sudden increase in their levels can cause:
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Which Patients Qualify For Monoclonal Antibody Treatment
Monoclonal antibodies are given for patients who are diagnosed with COVID but have mild to moderate disease and are at high risk for progression. So anyone 12 or older that’s at high risk for progression, and that would include people who are overweight or obese, people with diabetes, with chronic kidney disease, heart disease, lung disease, those who are immunosuppressed, and people who have other complex medical conditions, and people over 65. Those are all at high risk for progression, so they can all be candidates for monoclonal antibodies.
What Are The Risks Or Complications Of Using Monoclonal Antibodies
Infusion reactions are common, and occur during or shortly after monoclonal antibody treatment. These occur when your body has a strong immune response to the monoclonal antibody treatment. Common signs of infusion reaction are rash, fever, rigors/chills, shortness of breath, sweating, changes in blood pressure and increased heart rate. Slowing down the infusion or decreasing the dose can help limit such reactions.
Therere more serious but less common risks linked to unwanted immune system reactions, such as acute anaphylaxis, cytokine release syndrome and serum sickness.
Acute anaphylaxis is a massive allergic reaction that can be life-threatening. Serum sickness happens when your bodys immune system attacks the antiserum, or a blood product containing the proteins that your healthcare team is using to try to help you. CRS is also called cytokine storm and can lead to organ damage.
Some of the risks related to monoclonal antibody therapy are specific to the type of condition being treated. For instance, tumor lysis syndrome is a condition thats usually caused by cancer treatment that can result in kidney failure.
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Possible Side Effects Of Monoclonal Antibodies
Monoclonal antibodies are given intravenously . The antibodies themselves are proteins, so giving them can sometimes cause something like an allergic reaction. This is more common while the drug is first being given. Possible side effects can include:
- Low blood pressure
Compared with chemotherapy drugs, naked mAbs tend to have fewer serious side effects. But they can still cause problems in some people. Some mAbs can have side effects that are related to the antigens they target. For example:
- Bevacizumab is an mAb that targets a protein called VEGF that affects tumor blood vessel growth. It can cause side effects such as high blood pressure, bleeding, poor wound healing, blood clots, and kidney damage.
- Cetuximab is an antibody that targets a cell protein called EGFR, which is found on normal skin cells . This drug can cause serious rashes in some people.
Monoclonal Antibody Or Antiviral Therapy
UCHealth is encouraging people at risk of getting very sick from COVID-19 to test as soon as they detect symptoms. There are treatments available at your local pharmacies that can prevent severe illness, but they need to be taken with 5 days of when you first have symptoms. In some pharmacies you can test and get treatment all in the same visit.
Who should be considered for monoclonal antibody or antiviral therapy?
This treatment is for people who have recently been diagnosed with COVID-19, have mild symptoms, and are at high risk for getting very sick.
People at risk of getting very sick from COVID-19 include:
- People who are age 65 or older.
- People who are overweight .
- Pregnant people.
- People with a weakened immune system .
- People with certain conditions, such as: cancer kidney, liver, lung or sickle cell disease dementia diabetes Down syndrome heart conditions HIV infection certain mental health conditions current or former smoker organ transplant recipient stroke substance use disorder tuberculosis.
People who are not in one of the high-risk groups will not be considered under the FDA guidance at this time.
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Monoclonal Antibodies And Their Side Effects
One way the body’s immune system attacks foreign substances is by making large numbers of antibodies. An antibody is a protein that sticks to a specific protein called an antigen. Antibodies circulate throughout the body until they find and attach to the antigen. Once attached, they can force other parts of the immune system to destroy the cells containing the antigen.
Researchers can design antibodies that specifically target a certain antigen, such as one found on cancer cells. They can then make many copies of that antibody in the lab. These are known as monoclonal antibodies .
Monoclonal antibodies are used to treat many diseases, including some types of cancer. To make a monoclonal antibody, researchers first have to identify the right antigen to attack. Finding the right antigens for cancer cells is not always easy, and so far mAbs have proven to be more useful against some cancers than others.
NOTE: Some monoclonal antibodies used to treat cancer are referred to as targeted therapy because they have a specific target on a cancer cell that they aim to find, attach to, and attack. But other monoclonal antibodies act like immunotherapy because they make the immune system respond better to allow the body to find and attack cancer cells more effectively.
When Are Monoclonal Antibodies Used To Prevent Covid
There is some exciting news about preventing COVID-19 infection in certain high-risk groups. AstraZenecas monoclonal antibody therapy, EVUSHELD is the only authorized therapy for prevention of COVID-19. This is sometimes also referred to as pre-exposure prophylaxis . EVUSHELD also appears to provide protection from the Omicron variant. Evushield is given by an injection when it is used to prevent COVID-19.
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Lack Of Global Access
The high cost of mass-producing monoclonal antibodies, along with the complexities of implementation, make the treatment inaccessible to many low- and middle-income countries.
According to a report by the International AIDS Vaccine Initiative and Wellcome, a global charity that funds biomedical research, around 80% of all monoclonal antibody therapies â including those for cancer â are sold only in the U.S., Canada, and Europe. This leaves just 20% for the rest of the worldâs population.
Monoclonal COVID-19 therapies are available mostly for free in the U.S. However, there are likely barriers to access in other countries.
Another key aspect of this treatment is that healthcare professionals must administer it at specialized medical facilities, such as hospitals or treatment centers, over multiple sessions in order to show benefit.
The pandemic and increased COVID-19 cases have heavily limited these resources, making it more difficult to distribute this treatment.
In the U.S., Regeneron state that they have âestablished best practices for setting up these separate spaces and training staff, while infusion time for REGEN-COV has also been reduced to as low as 20 minutes.â
âSubcutaneous administration and lower doses are also being tested, which could further enhance convenience of administration in the future.â
The next few sections look at some alternative COVID-19 treatment options.
The Rise Of The Serological Test For Blood Grouping
Initially, the adoption of serological testing of blood before transfusion was limited. By the 1940s, however, it had become a common procedure conducted ahead of transfusion for working out ABO incompatibilities. In 1945, further improvements were made as a result of the work of Robin Coombs, an English pathologist at Cambridge University researching hemolytic disease among newborns, a condition brought about by Rhesus incompatibility which results in antibodies from a pregnant mother’s blood destroying the blood of her baby in her womb. Importantly, he devised a test for identifying antibodies reactive with erythrocytes which fell outside of the main ABO blood grouping system. His test was critical given that other blood groups had now been identified in addition to Landsteiner’s 4 and the fact that severe transfusion reactions were still common. The Coombs’ test not only helped in the management of rhesus incompatibility, but reduced the problems associated with transfusion.1,2
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Mabsa Potential Reagent For Blood Grouping
Initial test results from Sacks and Lennox’s anti-A mAb disappointingly indicated it to be a weak reagent for blood typing compared with human serum. This dulled the team’s enthusiasm for about a month, but their excitement was re-ignited when they developed a second anti-A mAb, purposefully this time. Tests indicated it was potentially a potent blood typing reagent. Critically, the mAb showed several advantages over conventional typing sera. Describing the results, Sacks wrote, Monoclonal anti-A produces a clearly visible reaction with red cells, improving the recognition of A and AB cells. The clearest benefit is seen with the weaker blood types of A poorly detected by conventional grouping serum Our present reagent is about 3 times as potent as conventional serum. Additional improvement in the speed and strength of red cell clumping can be achieved by concentrating the monoclonal antibody 4 times so that it equals the potency of hyperimmune commercial serum.4
The team believed the adoption of mAbs as reagents for blood typing offered a significant advantage in terms of reducing costs. The base line they used for the cost savings was hyperimmune serum, which on average cost £250 per liter. As they argued,
A significant advantage of the hybridoma technology was that it provided reagents that did not change over time. In this way everything that was learned about one batch could be reused for the next.10
Mabs Slip Into Routine Blood Grouping Practice
Some idea of Celltech’s achievement can be seen from the fact that by 1989 over half of the world’s blood-typing reagents were based on mAbs produced by the company.14 Celltech’s success reflected a wider uptake of mAbs as blood reagents, which grew considerably in the 1980s. Their popularity was rooted in the fact that their quality often exceeded that of conventional US FDA licensed reagents. Moreover the technology afforded uniform batch-to-batch control, so more readily fulfilled the FDA licensing requirements than conventional reagents. The mAb reagents were also free of the contaminants which was not the case with conventional blood serum. On top of this, large-scale production was now feasible and more effective than securing antiserum from human volunteers. Now 1,000 liters of mAb supernatant could be produced in just 18 days, the equivalent of 2,000 individual human donations gathered through an automatic collection process. Importantly, the mAb reagents helped eliminate the workload involved in evaluating large numbers of small individual donations. The successful creation of mAb reagents for blood typing also ethically challenged the continuation of the risky practice of immunising volunteers to secure conventional reagents.18
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What Treatments Can Be Used For Covid
Doctors have developed effective treatments for hospitalized patients but none of these are monoclonal antibody treatments.
- Dexamethasone is a corticosteroid . In patients who need extra oxygen or are on a ventilator, dexamethasone can reduce risk of death.
- Remdesivir is an antiviral drug. It can be used in people over the age of 12 weighing 88 pounds or more. It can help speed up the recovery time for people with COVID-19.
- Baricitinib in combination with remdesivir is available for use in patients over the age of 2 who need respiratory support.
- Blood thinners in low doses are frequently used to prevent blood clots. Many people with COVID-19 develop them. Doctors may prescribe higher doses of blood thinners in people who are at high risk for developing blood clots.
Scientists continue to study COVID-19. They update guidance on treatments as new evidenced-based research becomes available.
Purvi Parikh, MD, FACAAI is an adult and pediatric allergist and immunologist at Allergy and Asthma Associates of Murray Hill in New York City. She is on faculty as Clinical Assistant Professor in both departments of Medicine and Pediatrics at New York University School of Medicine.
The following information is courtesy of Combat Covid
How Do Monoclonal Antibodies Work Against Cancer
Monoclonal antibodies are immune system proteins that are created in the lab. Antibodies are produced naturally by your body and help the immune system recognize germs that cause disease, such as bacteria and viruses, and mark them for destruction. Like your bodys own antibodies, monoclonal antibodies recognize specific targets.
Many monoclonal antibodies are used to treat cancer. They are a type of targeted cancer therapy, which means they are designed to interact with specific targets. Learn more about targeted therapy.
Some monoclonal antibodies are also immunotherapy because they help turn the immune system against cancer. For example, some monoclonal antibodies mark cancer cells so that the immune system will better recognize and destroy them. An example is rituximab, which binds to a protein called CD20 on B cells and some types of cancer cells, causing the immune system to kill them. B cells are a type of white blood cell.
Other monoclonal antibodies bring T cells close to cancer cells, helping the immune cells kill the cancer cells. An example is blinatumomab , which binds to both CD19, a protein found on the surface of leukemia cells, and CD3, a protein on the surface of T cells. This process helps the T cells get close enough to the leukemia cells to respond to and kill them.
Some monoclonal antibodies bring t cells close to cancer cells, helping them kill cancer cells.
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Do I Still Need Monoclonal Antibody Therapy If I’m Not Feeling Sick Yet
Dr. Huang: For monoclonal antibody therapy to be most effective, it needs to be taken as early in the disease course as possible. So, the sooner the better even if you’re not feeling that bad yet.
In high-risk patients, receiving treatment earlier, when symptoms are less severe, may help prevent progression of the disease that would otherwise require hospitalization.
Help The Immune System To Attack Cancer
Other MABs work by acting on cells of the immune system. For example, a type of immunotherapy called checkpoint inhibitors. Checkpoint inhibitors block proteins that stop the immune system attacking cancer cells.
Checkpoint inhibitors block different proteins, including:
So you might hear these drugs named after these checkpoint proteins for example, CTLA-4 inhibitors, PD-1 inhibitors and PD-L1 inhibitors.
Examples of checkpoint inhibitors include:
- ipilimumab – a treatment for advanced melanoma
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Trigger The Immune System
Some MABs trigger the immune system to attack and kill cancer cells.
Although cancer cells are abnormal, they develop from normal cells so they can be difficult for the immune system to spot.
Some MABs attach themselves to cancer cells, making it easier for the cells of the immune system to find them. This process is called antibody-dependent cell-mediated cytotoxicity or ADCC.
Below is a short video showing how MABs work when they trigger the immune system.
Monoclonal antibodies which trigger the immune system to treat cancer
An injected monoclonal antibody seeks out cancer cell proteins.
The monoclonal antibody bind to the proteins.
The antibodies signal to immune cells.
The immune cells arrive and punch holes in the cancer cell. The cancer cell dies.
Examples of MABS that work in this way include:
- rituximab a treatment for chronic lymphocytic leukaemia and some types of non Hodgkin lymphoma
- cetuximab a treatment for advanced bowel cancer and head and neck cancer
- trastuzumab used to treat breast cancer and stomach cancer
You can find more information about these in our list of cancer drugs.