According to the accessible data from the Food and Drug Administration (FDA), certolizumab pegol, or CIMZIA (brand name), is a type of drug that involves a monoclonal antibody. Since the mid-1970s, drugs that take advantage of monoclonal antibodies have been growing in numbers. To say that advancements in modern medicine are quite astonishing is an understatement. The world of medicine is always changing. There are constantly new drugs and treatments in development and going through clinical trials in order to be approved for public use. While we do not get to see what is going on during different phases of drug development, it is implied that it is a rigorous process and that everything that is done is in line with the regulations that the U.S. Food and Drug Administration has set forth.
According to an article from MedicineNet, monoclonal antibodies for a particular antigen are known to have the same molecular make-up, such as variable region and constant region of the molecule. Moreover, they come from the same type of B cell clone. These antibodies are more specific in their response because all of the monoclonal antibodies from a particular B cell can only bind to one specific epitope. Monoclonal antibodies are different from polyclonal antibodies because polyclonal antibodies come from a number of different B cells. Each of these B cells are reacting in their own way to different epitopes that are found on the antigen. Working with drugs that involve monoclonal antibodies allow researchers and drug developers to have more control over the response that the drug can elicit.
According to the accessible data from the Food and Drug Administration (FDA) (mentioned in the first sentence of the blog), certolizumab pegol, or CIMZIA (brand name), is a type of drug that involves a monoclonal antibody. Specifically, the monoclonal antibody in the drug has the ability to target and attach to a tumor necrosis factor (TNF). TNFs are a type of pro-inflammatory cytokine. By binding to this TNF, specifically TNFα, the antibody can scale down, or even prevent inflammation (and other issues that are related to inflammation) that is brought about by this TNF. For example, for an individual who has Crohn’s disease (a type of inflammatory bowel disease), this drug can help alleviate the objective and subjective effects of the disease in a patient. Moreover, these can include abdominal pain, diarrhea, and fever. CIMZIA is known to impact the actual immune response because inflammation occurs in individual’s with Crohn’s disease, which involves TNF. This inflammation can be caused when the immune system seeks out non-pathogenic bacteria that is found throughout the body (mainly in the gut!). Specifically, this monoclonal antibody negatively impacts the innate response by reducing its effects (which in a way is also a positive effect for us because the immune system was targeting harmless bacteria, which we do not want!). TNF is mainly involved in the innate immune response.
As with all drugs and treatments, CIMZIA has the potential to cause side effects in the individual that is taking the drug. These include:
- Allergic Reactions (Rash on the skin, itchiness, swollen throat and face):
- Neurological Problems (Nerves in the eyes are the target for inflammation (this inflammation gets worse), seizures)
- Heart Problems (Heart Failure)
- Issues regarding the number of blood cells present (Leading to increase in intensity of signs and symptoms that the drug was supposed to treat)
- Urinary Tract Infections (UTIs)
- Upper Respiratory Infections (URIs)
With these side effects, it is important to discuss why they might occur. An allergic reaction may occur in an individual because there is natural rubber in the cap of the syringe that could cause an allergic reaction in those that do not react well with latex. In addition, neurological problems, such as inflamed eye nerves and seizures, can result from this drug because it could make the inflammation worse instead of reduce it (depending on the person), affecting the sensitive components of the body, like the nerves. While the disease does mainly target the gastrointestinal tract, it can also affect the eyes because it consists of tissue that is very similar to that found in the gastrointestinal tract. The drug can also cause an imbalance to the electrical activity that is going on in the brain, resulting in a seizure. Heart failure is a potential side effect because CIMZIA may overwork and damage the heart, depending on how hard the heart muscle has to pump the blood throughout the body. Moreover, in some cases, the body may not be able to quickly produce these blood cells that are needed, resulting in blood problems. Due to this issue, signs and symptoms, such as diarrhea and abdominal pain can get worse, because there is not a sufficient number of blood cells needed to combat the disease fully and effectively. In addition, UTIs and URIs are more likely to occur because the patient is now immunosuppressed, and their lymphocytes are preoccupied and are not able to deal with other incoming pathogens well.
This drug has the ability to make individuals susceptible to other disease infections, including those that the individual may have already recovered from (or thought they did). With this drug, Hepatitis B virus that is already present in the blood has the ability of becoming activated again. Because this drug has the ability to subdue the immune response, it is easier for the Hepatitis B virus to make a comeback and infect the individual again. Therefore, it is highly recommended that individuals should be tested to see if they are positive for Hepatitis B before they are given CIMZIA. Cancers, such as lymphoma, can result from this drug. The lymphocytes could be overworked and released in large quantities, resulting in a higher chance for something to go wrong within one of these cells. It is important to note that one of the main causes of lymphoma is that the growth of lymphocytes exceeds abnormal levels.
Prior to completing research on the topic of monoclonal antibodies, I was not aware that drugs ending in “-mab” indicate ones that involve an antibody! I previously interned at a pharmaceutical company and many drugs ended with those letters. While I did not learn the exact mechanism behind the drugs, I can better group them together now and see their common function. While these drugs have relieved many patients of the effects of Crohn’s disease, it is quite scary to see the risks that these patients have to take while on the medication as well. For example, potential adverse effects that deal with the heart and nerves, two of the most important components of the body in my opinion, can make the patients’ health even worse than before. Luckily, if the FDA has approved it, then that means that patients should be carefully chosen to take this medication in order to show significant progress in alleviating the effects of Crohn’s disease.
In addition, according to an article specifically detailing CIMZIA from MedicineNet, researchers reported that this medication should be administered via an injection. Specifically, the drug should be administered into the abdomen and/or thigh. If the patient responds favorably to this medication, then injections are essentially given each month. Currently, it is unknown regarding the safety of CIMZIA for individuals who are pregnant. However, for now, it is probably best to avoid this medication if possible, if that is the case. Therefore, the only way that an individual could get his or her hands on this medication is through a prescription (probably for the best).
Learning about how a drug is administered to a human is quite fascinating to me. There is always a reason why something is done, especially in the world of medicine. It makes sense that the drug would be directly injected into the abdomen and/or thigh, because those are the places in which the inflammation occurs. In addition, while CIMZIA has been approved by the FDA, it shows that there is still much to learn about each and every drug out there. While we do know many things about the human body, it is made up of many complex systems that we have yet to discover everything about. These aspects of medicine contribute to why I am so drawn to studying medicine and helping others. The world of modern medicine has yet to see a dry day!
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