As Dallas COVID cases surge, Regeneron monoclonal antibody treatment gains the spotlight
As COVID-19 cases rise in North Texas and across the country, new monoclonal antibody treatments from Regeneron and other companies have come to the fore. Here’s what preliminary research shows about these treatments.
They are effective in reducing the risk of hospitalization, but must be used early during an infection.
Treating COVID-19 with monoclonal antibodies may improve outcomes for people at higher risk for serious illness, according to clinical studies at Baylor University Medical Center, UT Southwestern Medical Center, and other research institutions across the country.
Researchers said antibody treatments can also reduce the likelihood of a person needing to be hospitalized, which is important as hospitals are overwhelmed with COVID cases.
However, drugs must be used as early as possible, preferably within the first week after a patient is infected. “We believe that antiviral drugs work best when they are used at the earliest,” said Dr. Robert Gottlieb, physician-scientist and lead investigator in multiple COVID-19 clinical trials at the Baylor Scott & White Research Institute, which is part of the nonprofit Baylor Scott & White Health System.
He said antibody treatments reduced the risk of hospitalization in people with mild to moderate COVID symptoms by 70% to 87% and improved their chances of survival, based on several large clinical studies conducted nationwide.
If a person is infected, he or she should still be “actively quarantined,” said Gottlieb. “Avoid infecting others. But find a place that can supply neutralizing monoclonal antibodies as early as possible if you are authorized to do so. “
Dr. Robert L. Gottlieb, Principal Investigator for Baylor Scott and White’s Active Clinical Trials on COVID-19, poses for a photo outside their research facility in Dallas, Thursday, March 26, 2020.(Tom Fox / employee photographer)
And most importantly, antibody treatments are no substitute for a COVID vaccine. “The neutralization of monoclonal antibodies is a therapeutic option as part of a safety net for COVID-19 that primarily begins with vaccination,” said Gottlieb.
The U.S. Food and Drug Administration recently issued emergency approval for Regeneron antibody treatment to people who tested positive for the coronavirus but are not yet showing symptoms. Gottlieb said this use could help protect people, such as survivors of lymphoma or leukemia, who are not expected to have a strong response to the vaccination.
In general, patients should get a referral before treatment – they cannot simply go to most infusion centers.
A doctor can determine whether monoclonal antibody therapy is the best course of treatment for people over the age of 12 with certain risk factors for developing a serious illness.
These risk factors include an underlying condition such as diabetes, cardiovascular disease, sickle cell disease, or chronic lung disease. People older than 65, obese, or pregnant may also be eligible for treatment.
Patients should have a doctor’s referral to receive treatment, which will be given as a one-hour intravenous infusion at various infusion centers in Dallas-Fort Worth. People cannot just go to most infusion centers and receive antibody treatment.
One of the state’s major infusion centers is in Fort Worth.
North Central Texas’s COVID-19 Regional Infusion Center, which opened in Fort Worth last month, is based on a partnership between the Department of State Health Services, the North Central Texas Trauma Regional Advisory Council, Cook Children’s Medical Center, and several others Agencies.
“I think the state saw that it … [some] Infusion centers, but it wasn’t enough, ”said Stephen Love, President and CEO of Dallas-Fort Worth Hospital Council. “That’s why they set up these larger infusion centers all over the country.”
Last month, Governor Greg Abbott announced that several of these publicly funded regional infusion centers would be opening across the state.
Hospitals welcome this development because it is a way of preventing more people from being hospitalized, Love said.
Many of the other antibody infusion centers are located within or adjacent to hospitals.
Dr. Mamta Jain, professor of internal medicine and infectious diseases at UT Southwestern Medical Center, said the current surge in COVID cases means hospital systems need to find the room and staff to monitor patients receiving monoclonal antibody treatment, while trying to figure this out which patients who come to the emergency room need to be hospitalized.
Love said the Fort Worth center can support up to 90 infusions per day at no patient expense. Depending on the number of patients, the center could possibly increase its capacities.
The center recently changed its guidelines to accept walk-in appointments, he said, but patients still have to meet the eligibility criteria. Without a doctor’s referral, a patient is not guaranteed an appointment, he said.
“I am sure the state will monitor the capacity, volume and activity very carefully,” said Love. Abbott announced that a second infusion center will open in McKinney on Thursday.
Three different antibody treatments, including one from Regeneron, have been approved for emergency use.
Gottlieb said the FDA has issued emergency clearances for three different monoclonal antibody treatments: Regeneron’s cocktail of casirivimab and imdevimab; Eli Lilly’s cocktail of bamlanivimab and etesevimab; and sotrovimab from GlaxoSmithKline and Vir Biotechnology. (The FDA has suspended the use and distribution of bamlanivimab along with etesevimab based on data on the prevalence of circulating coronavirus variants. This treatment is now approved in 22 states but not Texas.)
The Fort Worth center gives people infusions with Regeneron monoclonal antibody treatment.
Most of these treatments use combinations of monoclonal antibodies to preserve their therapeutic benefits. “I believe that for most things in microbiology and virology, the more you use things in combination, the harder it is to escape,” said Gottlieb.
Each of the monoclonal antibodies also target and bind to different segments of the viral protein. These antibodies then teach the immune system how to build a response to the virus.
Researchers plan to investigate when it is more effective to use one antibody treatment over another.
Jain, who oversees clinical trial efforts related to COVID at UT Southwestern, said clinical trials will be underway shortly that will help scientists learn more about new monoclonal antibody treatments through comparisons with those currently on have an emergency permit.
Dr. Mamta Jain, professor of internal medicine at UT Southwestern Medical Center in Dallas.(Brian Coats / UT Southwestern Medical Center)
Genome sequencing can also help scientists determine which variant of coronavirus a person has in research settings and use that information to figure out which treatment might be more effective against certain variants.
For example, clinical data showed that bamlanivimab together with etesevimab was not effective in people infected with the beta and gamma coronavirus variants. However, experts say there is no evidence that any of the current therapies against the Delta variant are less effective.
Jain said several more monoclonal antibody therapies developed by other drug companies including AstraZeneca and Bristol-Myers Squibb are being tested in a large clinical trial at UT Southwestern and across the country. Preliminary results of the study also show that treatment with Brii Biosciences monoclonal antibodies reduced the risk of hospitalization by 78%.
Researchers are also trying to figure out when treatment with monoclonal antibodies might benefit people who have already been hospitalized.
Jain said it is difficult to quickly determine who could benefit from inpatient monoclonal antibody treatments because patients have more advanced disease and are receiving other therapies. “There is probably a role [for monoclonal antibodies] on the stationary side, ”she said. “But I think we need to better define the patients for whom it will be beneficial.”
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