Monoclonal Antibody Therapy for COVID-19: What the COPD Community Needs to Know
Posted on December 13, 2021 |
This article was written by Michael W. Hess, MPH, RRT, RPFT.
Throughout much of the first year of the COVID-19 pandemic, there was little clinicians could do for people who tested positive for the virus but did not need hospitalization. People simply had to wait and see if they could manage their symptoms at home…or if they would get sick enough to be hospitalized and placed in intensive care. There was no easy way to predict which way people might go, no way to change the odds. That all started to change beginning in November 2020 when the U.S. Food and Drug Administration (FDA) started to issue emergency use authorizations for treatments using monoclonal antibodies.1
(NOTE: Because of the rapidly changing conditions of the pandemic, on Jan. 24, 2022, the FDA placed a hold on some of these authorizations. Due to the mutations of the Omicron variant, two of the mAb treatments that have been developed were found to be less effective. Because they are less effective, their emergency use authorizations were indefinitely withdrawn and distribution stopped. Please visit the U.S. Department of Health and Human Services for more information: https://aspr.hhs.gov/COVID-19/Therapeutics/Pages/default.aspx)
What are Monoclonal Antibodies?
Your body's immune system naturally produces proteins called antibodies to fight off infections, including viruses like COVID-19. Antibodies recognize foreign substances called "antigens" that cause illnesses. As they travel through the body, antibodies act like flags that tell the immune system to destroy infected cells. They can stop a virus from infecting new cells by blocking its ability to latch on to them. It usually takes time for the immune system to develop antibodies especially in people with a weak immune system because of disease, cancer treatments or old age. Vaccines make it easier and faster for the immune system to develop antibodies. But even with vaccines, it takes time for the immune system to develop a strong antibody response.
Modern research can sometimes provide a shortcut. Scientists can pinpoint antibodies that recognize specific antigens (like SARS-CoV-2 virus, which causes COVID-19) and can mass-produce them in a lab. These lab-made antibodies are called monoclonal antibodies (mAbs). Once the mAb can be produced in large quantities, it can be given to people in the form of an injection or infusion. Since these antibodies are already programmed to recognize the virus quickly, they can help the immune system fight infection right away.
While the pandemic is the first time many people have ever heard of mAbs, they actually have a fairly long and established history of use. The first mAb on the market was approved in 1986 after nearly 10 years of research & development.2 It was designed to help reduce the risk of organ rejection in people after kidney transplants. Since then, mAbs have been used safely in a wide variety of medical conditions including various cancers, asthma, macular degeneration, rheumatoid arthritis, and even infection with the Ebola virus.3
mAbs and COPD
So why should the COPD community be aware of these mAbs? Well, while we know that vaccination continues to be our best tool to avoid getting and spreading COVID-19, mAbs represent an important therapy for the COPD community. People with COPD have consistently been shown to have worse outcomes if they come down with COVID-19, including a higher risk for being hospitalized, a higher risk of respiratory failure, and a higher overall risk of dying.4
During the course of the pandemic, FDA has authorized the use of both individual mAbs and combinations (sometimes called 'cocktails') to help protect people who have tested positive for some variants of COVID-19, or who have been exposed to the virus that causes COVID-19 and are at high risk for worse outcomes. includes people 65 and older and people with chronic conditions like obesity, diabetes, heart disease, and lung diseases like COPD. Unfortunately, we've also seen situations where FDA has withdrawn authorization, because we're finding that some mAbs and cocktails aren't effective against some virus variants (like Omicron). Scientists are constantly researching new mAbs and combinations, as well as testing how they work against current and emerging variants.
It's a relatively simple procedure which usually consists of spending a few hours at an infusion center, or sometimes even a primary care office or urgent care center. The actual administration of the mAbs takes about an hour, and there is some observation time after the infusion to make sure there are no reactions. It's important to note that the sooner after exposure mAb therapy starts, the more effective it's likely to be! If treatment is delayed and more severe symptoms begin (like added shortness of breath or low oxygen levels), mAbs can't help. The US Department of Health and Human Services has set up a website to help you learn more information.
How can I find out how to get mAb therapy?
The answer depends on where you live. Many local health care systems have telephone referral lines where people can get more information on scheduling and find out if antibody treatment is right for them. Some states have also started setting up infusion centers to help take some of the load off from strained hospitals and clinics. The National Infusion Center Association website (https://covid.infusioncenter.org/) can also help you find a location near you. Even at these centers, people still need a prescription for mAb therapy, so be sure to contact your clinician before setting up an appointment. It's also important to remember that since mAbs that are effective against Omicron are in very limited supply, states and local hospital systems may have different rules for who is eligible to receive them. Finally, as evidence about how effective specific mAbs are against different variants changes, FDA authorization may change which ones are available. The COPD Foundation encourages everyone to continue to rely on other methods to stay healthy, including vaccines and boosters, wearing an appropriate mask, and social distancing.
With the uncertainty and frustrations of the pandemic, it's easy to forget there's a light at the end of every tunnel. While the world is not yet out of the woods, monoclonal antibodies are leading the way to lowering the risk of severe COVID-19 cases, especially for those at the highest risk, and even for those who are already vaccinated. That's a double dose of great news for everyone in the COPD community!
PLEASE NOTE: Best practices for the COVID-19 pandemic are changing rapidly, and we are working hard to keep up with the most accurate information. This post was last updated on May 4, 2022.
This blog post was supported by Regeneron.
References
- Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19 | FDA. Accessed November 11, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19
- Liu JKH. The history of monoclonal antibody development - Progress, remaining challenges and future innovations. Ann Med Surg. 2014;3(4):113-116. doi:10.1016/j.amsu.2014.09.001
- Shepard HM, Phillips GL, Thanos CD, Feldmann M. Developments in therapy with monoclonal antibodies and related proteins. Clin Med J R Coll Physicians London. 2017;17(3):220-232. doi:10.7861/clinmedicine.17-3-220
- Higham A, Mathioudakis A, Vestbo J, Singh D. COVID-19 and COPD: A narrative review of the basic science and clinical outcomes. Eur Respir Rev. 2020;29(158):1-13. doi:10.1183/16000617.0199-2020