Recent Data Suggests More People With COVID-19 Would Benefit From Monoclonal Antibodies

While the use of monoclonal antibody treatments for COVID-19 is quite limited, newly-published data on two types of these treatments is encouraging experts to update their recommendations.

Currently, the Infectious Diseases Society of America (IDSA) recommends against the routine use of the monoclonal antibodies and the National Institutes of Health (NIH) has said that there isn’t enough data to recommend for or against the treatment. But after the two companies that make the drugs issued press releases on new studies in late January, the IDSA held a webinar for physicians to evaluate the new data.

“This is a rapidly evolving field,” Rajesh Gandhi, MD, professor of medicine at Harvard Medical School and an infectious disease specialist, told the webinar participants.  

In November 2020, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) to both bamlanivimab, made by Eli Lilly, and for the combination of casirivimab and imdevimab made by Regeneron, for non-hospitalized patients with mild to moderate COVID-19 who are at high risk for severe disease because of other health issues. The authorizations were based on interim findings that showed these drugs reduced COVID-19-related hospitalizations and emergency room visits. 

EUAs are not drug approvals. They are authorizations that can be granted only during a public health emergency—like COVID-19—that permit certain drugs to be used based on some testing. EUAs do not demand as complete research findings as FDA approvals. 

What's New?

The press releases that Regeneron and Eli Lilly shared in late January—which had not been reviewed by outside scientists when they were released—showed even more encouraging results than the studies submitted for the EUAs. 

Eli Lilly announced that their treatment reduced the risk of hospitalizations or death by 70% in newly-diagnosed COVID-19 patients who were not hospitalized. Ten deaths occurred, but they were in the patients who received a placebo.

Regeneron’s news release said that housemates of people in a clinical trial who had received the Regeneron monoclonal antibodies were less likely to develop COVID-19 than people in the trial on a placebo. 

The new data could help rev up interest and acceptance surrounding monoclonal antibodies. Because they are already FDA-authorized, they can be accessible (with a prescription) to patients outside of clinical trials.

At the IDSA webinar, Gandhi said there's still a lot we don't know yet, like the optimal timing to receive monoclonal antibody treatment, and how COVID-19 variants may change the effectiveness of these drugs.

Who Should Be Considered For Monoclonal Antibody Treatment?

The basic eligibility criteria for monoclonal antibody treatment, according to a recent fact sheet from the American College of Emergency Physicians, includes: 

• The patient is positive for COVID-19
• The patient is age 12 or older 
• The patient is at high risk for severe disease or hospitalization based on risk factors such as as heart disease, obesity, and diabetes
• It has been 10 days or less from the start of COVID-19 symptoms

Blockers to Treatment

While the latest research about the effectiveness of available monoclonal antibodies is a good thing, it's still fairly difficult to pursue this treatment method.

The drugs, at least for now, can only be given as intravenous infusions in a hospital or clinic setting. Some hospitals, overwhelmed by caring for COVID-19 patients, haven’t been able to spare staff or space to set up the clinics, Jason Gallagher, PharmD, clinical professor at Temple University School of Pharmacy, tells Verywell.

People who think they will benefit from monoclonal antibodies will also need a prescription. According to Brian Nyquist, MPH, executive director of the National Infusion Center Association, patients and/or caregivers need to be proactive in order to secure a prescription:

• If you test positive for COVID-19, ask the testing site if they have a doctor on staff who can write the prescription, which may be faster than reaching out to your own doctor. 
• If not, reach out to your own doctor or ask the testing site if they have a doctor they can refer you to for a consult on monoclonal antibody treatment.
• If you don’t have a prescription but have located an infusion center that has the drugs on hand, ask if they have a doctor that can prescribe the drugs. (Some infusion sites are staffed by nurses who are proficient at infusions but may not be able to write the prescription for the treatment.) 

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.