What Is Monoclonal Antibody Therapy & Who Is Eligible to Receive It?Jan. 13, 2021 - Katie McCallum
When the pandemic first began, no specific treatment for COVID-19 existed. This past November, however, the FDA granted Emergency Use Authorization (EUA) for two new COVID-19 treatments, both of which are monoclonal antibody therapies.
"For the first eight months of the pandemic, there was very little that clinicians could do for those who tested positive for COVID-19 but did not require hospitalization — beyond taking a wait-and-see approach, explains Dr. Howard J. Huang, medical director of the Houston Methodist Lung Transplant Center. "If a person's symptoms became severe, we could at that point manage and treat the resulting complications via oxygen therapy and other methods. But, the ideal scenario is to prevent severe symptoms from ever developing in the first place. With these new monoclonal antibody therapies, we now have a way to do that for certain patients at increased risk for developing severe disease."
If you've tested positive for coronavirus and are wondering what to do next, Dr. Huang is here to answer the common questions you may have about monoclonal antibody therapy for COVID-19.
How does monoclonal antibody therapy work?
Dr. Huang: Monoclonal antibody (mAb) therapy, also called monoclonal antibody infusion treatment, is a new way of treating COVID-19 for individuals who have tested positive for the virus and are at high risk for developing severe illness. The goal of this therapy is to help prevent hospitalizations, reduce viral loads and lessen symptom severity.
This new type of therapy relies on monoclonal antibodies. These are antibodies that are similar to the ones your body would naturally make in response to infection. However, monoclonal antibodies are mass-produced in a laboratory and are designed to recognize a specific component of this virus — the spike protein on its outer shell. By targeting the spike protein, these specific antibodies interfere with the virus' ability to attach and gain entry into human cells.
The two monoclonal antibody therapies currently available are the bamlanivimab and a combination of the casirivimab and imdevimab.
Who is eligible to receive monoclonal antibody therapy?
Dr. Huang: The FDA granted Emergency Use Authorization (EUA) for monoclonal antibody infusions in adults who are high risk for developing severe COVID-19 and who have not been admitted to the hospital.
Those who are at high risk include people who:
- Are 65 years of age or older
- Are at least 55 years of age and have heart disease, hypertension or a chronic respiratory disease such as COPD
- Have a BMI above 35
- Have chronic kidney disease
- Have diabetes
- Are receiving immunosuppressive treatment or have an immunosuppressive disease
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.
How is monoclonal antibody therapy administered?
Dr. Huang: Monoclonal antibody therapy is given through intravenous (IV) infusion. These infusions are given in one of our outpatient infusion centers and require about an hour to administer, followed by an hour of observation and monitoring.
One possible side effect of monoclonal antibody therapy is an allergic reaction. These reactions typically only occur during infusion or soon after, and your care team will closely monitor for any signs of an allergic reaction. However, because an infusion reaction can also be delayed, contact your doctor immediately if you notice any of the following signs of an allergic reaction:
- Fever and/or chills
- Shortness of breath
- Low blood pressure
- Swelling of lips, face or throat
- Muscle aches
- Hives or itchiness
Does receiving monoclonal antibody therapy mean I can cut my isolation short?
Dr. Huang: Anyone who has tested positive for COVID-19 needs to quarantine — regardless of whether or not he or she has received monoclonal antibody therapy.
This means self-isolating in your home and away from other household members for:
- 10 days since testing positive or
- 10 days after your symptoms first appear and
- At least 24 hours after your symptoms have improved and you've been without fever (without the use of fever-reducing medications)
Only after meeting the above criteria can you return to work and leave your home (while still social distancing and wearing a mask).
Can I receive monoclonal antibody therapy if I'm pregnant or breastfeeding?
Dr. Huang: Because there's very limited data regarding how this therapy affects pregnant women and unborn babies, the risk of this new therapy may outweigh the benefits in some cases. If you are high risk and develop COVID-19 while pregnant or breastfeeding, it's important to discuss your treatment options and your specific situation with your doctor.
Is there anything I need to know about receiving monoclonal antibody therapy?
Dr. Huang: After receiving monoclonal antibody therapy, it's recommended that you wait 90 days before receiving the COVID-19 vaccine. If you already received the first dose of vaccine before monoclonal antibody therapy, current CDC guidelines recommend you wait 90 days before receiving the second dose.