Table of ContentsView AllTable of ContentsHow They WorkDiagnostic UsesTherapeutic UsesCommon Side Effects
Table of ContentsView All
View All
Table of Contents
How They Work
Diagnostic Uses
Therapeutic Uses
Common Side Effects
Amonoclonal antibody(mAb) is a type of immune protein produced in a lab that binds to a specific protein on a cell called anantigen. As with naturally occurringantibodies, monoclonal antibodies stimulate theimmune systemto act against disease-causing agents.
Matching a specific human-made antibody to a particular target has many applications in medicine. This includes the targeted treatment of diseases likecancer,rheumatoid arthritis, andCOVID-19.Monoclonal antibodies can also be used to type blood samples, detect pregnancy, and diagnose infectious and noninfectious diseases.
This article explains how monoclonal antibodies are created and used in medicine. It also describes the risks and benefits of monoclonal antibody therapies that are approved in the United States.
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How Monoclonal Antibodies Work
Monoclonal antibodies are designed to mimic the action of naturally occurring antibodies. The term “monoclonal” refers to the process of creating an exact copy (a clone) of cells that produce antibodies.
There are several ways to produce monoclonal antibodies, but they traditionally involve exposing a mouse, rabbit, horse, or other animal to a disease-causing agent like a virus or cancer. The animal’s B cells are then harvested, manipulated, and cloned to mass-produce antibodies specific to the disease-causing agent.
The animal-derived antibodies can then be further manipulated to prevent the immune system from regarding them as foreign invaders and attacking them. This may involve fusing or grafting mouse antibodies onto human antibodies.
Types of Monoclonal Antibody
Monoclonal antibodies can also be produced using recombinant DNA technology, in which the genetic material of an antibody is transferred to a host cell (such as yeast, bacteria, or mammalian tissue) capable of churning out mass quantities of the antibody. Unlike the traditional method of mAb production, however, recombinant antibodies are made entirely in the lab or production facility without animals.
History
Diagnostic Uses of Monoclonal Antibodies
One of the earliest applications of monoclonal antibodies was their use in diagnosing medical conditions. Monoclonal antibodies function in the same way as naturally occurring antibodies in that they “recognize” foreign agents. By doing so, they can detect not only disease but important variations in normal cells (such as blood cells) and abnormal cells (such as cancer).
One of the first applications of monoclonal antibodies was inblood typingandtissue typing(used to preventorgan transplant rejection). In both cases, the tests ensure a “match” between a blood or tissue donor and a blood or tissue recipient.
Monoclonal antibodies are also used to identify infectious and noninfectious diseases. Because they are highly specific, monoclonal antibodies offer a high degree of accuracy when used in blood, urine, and tissue tests.
This includes theWestern blotused to diagnose diseases based on specific proteins in a blood or tissue sample. A positive result is returned when the introduced antibody binds to its target antigen in the sample.
The Western blot can diagnose several common and uncommon diseases, including:
Monoclonal antibodies can also be applied to a technique calledimmunohistochemistry (IHC), in which specific proteins are “stained” so that they can be seen under the microscope. Immunohistochemistry is widely used todiagnose cancerand can also help predict the likely outcome (prognosis) based on thetumor-specific antigen.
The same principles are applied tohome ovulation kitsin which monoclonal antibodies bind to the antigen ofluteinizing hormone (LH).
Therapeutic Uses of Monoclonal Antibodies
In medicine, monoclonal antibodies are used as a form ofimmunotherapyin which you stimulate the immune system to fight disease. Because of the way that they work, monoclonal antibodies can also be considered a form oftargeted therapy, in which specific cells are targeted and (unlike withchemotherapy) others are left untouched.
Cancer is one of the diseases in which monoclonal antibodies play an increasingly important role. But, there are other conditions, includingautoimmune diseases, that benefit from monoclonal antibody therapy.
Therapy Types
The five types of therapies that deliver and use monoclonal antibodies in different ways are:
Diseases Treated With Monoclonal Antibodies
Treatment of Cancer
There are at least 25 monoclonal antibodies licensed for the treatment of different cancers, including:
Monoclonal antibody therapies are often reserved for advancedmetastaticcancer. This is when cancer has spread beyond the original tumor, and the treatment is focused on slowing disease progression and prolonging life.
What to ExpectMonoclonal antibodies for cancer are deliveredintravenously(IV, within a vein) in a cancer treatment center.The IV infusion usually takes only 20 to 25 minutes (though it can be longer), but you would be asked to wait for an hour before leaving to ensure you don’t have an allergic reaction.
What to Expect
Monoclonal antibodies for cancer are deliveredintravenously(IV, within a vein) in a cancer treatment center.The IV infusion usually takes only 20 to 25 minutes (though it can be longer), but you would be asked to wait for an hour before leaving to ensure you don’t have an allergic reaction.
Treatment of Autoimmune Diseases
Autoimmune diseases are those in which the immune system mistakenly attacks its own cells. There are at least 20 different monoclonal antibodies licensed for the treatment of autoimmune diseases such as:
Monoclonal antibodies used for these conditions work in different ways. Some bind to proteins that trigger damaging autoimmuneinflammation. These include proteins known astumor necrosis factor (TNF)andinterleukin (IL), both of which are linked to many autoimmune conditions.
Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) are three monoclonal antibodies classified as TNF inhibitors, while Actemra (tocilizumab) is one of the better-known IL inhibitors.
Other monoclonal antibodies like Rituxan (rituximab) target B cells that produce harmful antibodies, known as autoantibodies, that initiate the autoimmune assault.
Monoclonal Antibodies Used to Treat Autoimmune Diseases
Other Uses
Many monoclonal antibodies have multiple indications and can be used to treat different diseases. At the same time, there are newer monoclonal antibodies that specifically target and treat diseases unrelated to cancer or autoimmunity.
These include monoclonal antibodies licensed for the treatment of:
There are also monoclonal antibodies used for the prevention ofkidney transplant rejection,migraine headaches, and recurrentClostridioides difficileinfection.
Researchers are also investigating monoclonal antibodies (such as aducanumab and lecanemab) that may one day treat neurodegenerative disorders likeAlzheimer’s diseaseorParkinson’s disease.
Side Effects
As valuable as monoclonal antibodies are for the treatment of cancer and other diseases, they can cause sometimes significant side effects. The side effects can vary from one drug to the next and tend to be more profound when delivered intravenously (due in large part to the size of the dose).
The risk of side effects tends to be dose-dependent, meaning higher doses translate to a higher risk (or severity) of side effects.
With that said, monoclonal antibodies used to treat autoimmune diseases are often used on an ongoing basis to maintaining control of symptoms. The extended use of these drugs can have a cumulative effect, suppressing the immune function and causing side effects even at lower doses.
When use for the treatment of cancer, common side effects of monoclonal antibodies may include:
When used for the treatment of autoimmune diseases and other chronic illnesses, common side effects may include:
Possible Complications
The prolonged use of monoclonal antibodies is associated with an increased risk for all types of infections, includingtuberculosis (TB)and potentially severe fungal infections likeinvasive candidiasis(in which a yeast infection spreads to internal organs).
Monoclonal antibodies can also cause the reactivation of TB andhepatitis B. People prescribed monoclonal antibodies should be tested for TB and hepatitis B before starting treatment in the event the diseases are undiagnosed.
Monoclonal antibodies can also trigger a potentially life-threatening reaction known asanaphylaxis, which, if left untreated, can lead to shock, coma, asphyxiation, organ failure, and death.
Anaphylaxis doesn’t usually occur with the first monoclonal treatment but only after a person has been reexposed to the drug. Symptoms tend to develop one to two hours after treatment.
When to Seek Emergency CareCall 911 or have someone rush you to the nearest emergency room if you experience the followingsigns of anaphylaxisafter receiving monoclonal antibodies:Shortness of breathWheezingA sudden outbreak of rash or hivesSlowed or irregular heartbeatsNausea and vomitingSudden diarrheaSwelling of the face, tongue, or throatA feeling of impending doom
When to Seek Emergency Care
Call 911 or have someone rush you to the nearest emergency room if you experience the followingsigns of anaphylaxisafter receiving monoclonal antibodies:Shortness of breathWheezingA sudden outbreak of rash or hivesSlowed or irregular heartbeatsNausea and vomitingSudden diarrheaSwelling of the face, tongue, or throatA feeling of impending doom
Call 911 or have someone rush you to the nearest emergency room if you experience the followingsigns of anaphylaxisafter receiving monoclonal antibodies:
Summary
Monoclonal antibodies are artificially produced antibodies that can be used to diagnose, treat, or prevent an ever-widening array of diseases and medical conditions, including cancer, autoimmune diseases, and COVID-19.
Traditionally, the production of monoclonal antibodies involved mice, but modern production techniques will either fuse, graft, or insert the genetic material of mouse antibodies onto human antibodies to prevent the immune system from attacking them. They can also be made entirely in the test tube with recombinant DNA technology.
Despite their numerous benefits, monoclonal antibodies can cause side effects, particularly when given in high doses or over extended periods of time.
A Word From Verywell
If prescribed monoclonal antibodies for any reason, be sure to ask as many questions as you need to understand the benefits and risks. While monoclonal antibodies are definite game-changers for many diseases, they have their limitations and may not be the “magic bullet” you presume them to be.
By speaking with your healthcare provider, you can be fully prepared for treatment and better able to avoid possible side effects and complications.
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