DULUTH — A new use of monoclonal antibodies is now being used at St. Luke's and Essentia Health to prevent COVID-19 in the highest-risk patients before they are potentially exposed to the virus.
Evusheld, an injection of two different types of laboratory-made monoclonal antibodies, was issued emergency-use authorization by the U.S. Food and Drug Administration in December. Patients who are eligible to receive the treatment are immunocompromised people age 12 and older for whom the COVID-19 vaccines are not effective, including solid organ transplant recipients, patients undergoing chemotherapy and people who take immunosuppressing medication.
Jonathan Shultz, an emergency physician at St. Luke's in Duluth, said most patients who qualify for this treatment have been forced to stay isolated for the last two years in order to avoid exposing themselves to the virus.
"There’s a lot of patients who are in this group," he said. "They have not been able to return to normal life like we have. As we all take off our masks and go out to restaurants, they have not been able to because they’re so high risk.”
Evusheld directly injects the antibodies into patients' bodies because their weakened immune systems can't produce natural antibodies. Because the patients are vulnerable to COVID, they receive the treatment in infusion centers instead of standard COVID treatment centers or floors, where monoclonal antibodies are more commonly given to people who are already infected with COVID-19 to prevent the infection from becoming severe.
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“Vaccines have proven to be the best defense available against COVID-19," said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. "However, there are certain immune-compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and therefore cannot receive one and need an alternative prevention option."
Ben Anderson, a pharmacist at St. Luke's infusion center, said they've been administering Evusheld to about five or six patients a week, on average, since the hospital began receiving it in January. The doses are sent from the federal government to state departments of health, which then distribute Evusheld to hospitals across the state as it becomes available.
According to the Minnesota Department of Health, sites were expecting as many as 250,000 patients in Minnesota to qualify for the treatment, but the drug has been in short supply. Recently, it's becoming more easily accessible, Anderson said.
Anderson and two other professionals at St. Luke's undertook the task of sorting their eligible patients into four categories, beginning with the highest-risk patients, then contacting them one by one to let them know they were able to receive Evusheld. Anderson said a big part of this process was educating people about the treatment, which is the first-ever use of monoclonal antibodies for disease prevention.
Another hurdle St. Luke's had to jump was acquiring Evusheld for its Wisconsin patients. Because the doses at St. Luke's were given by the Minnesota Department of Health, they could only be used on Minnesota patients. Anderson said Essentia's Superior hospital was receiving doses for Wisconsin patients, and helped St. Luke's find a contact at the Wisconsin Department of Health Services.
“It does add another layer of complexity, working with two separate state governments on that, but now we are able to offer both Minnesota and Wisconsin patients doses of Evusheld,” Anderson said.
St. Luke's now receives Evusheld for Wisconsin patients, including some leftover doses from other Wisconsin hospitals that wouldn't be used before they expired.
"This is a story of health care organizations cooperating together to use these medicines to the greatest benefit of the patients, rather than to the benefit of the organization,” Shultz said, noting health care organizations are typically extremely competitive.
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Anderson said they've contacted all of St. Luke's highest-risk patients, and have administered Evusheld to about half of those 200 patients. They are now contacting patients in risk categories 2 and 3. He said patient reactions to the drug have been varied, with some people declining treatment for various reasons, while others were calling the health care system the day it received emergency-use authorization because they couldn't wait to come in and get their dose.
Some people experience allergic reactions to Evusheld, so patients at St. Luke's are monitored for an hour after receiving the two-dose intramuscular injections. Some recipients in a trial experienced cardiac adverse events, but a direct link between the events and Evusheld was not found because all people had preexisting cardiac conditions.
An emergency-use authorization is not the same thing as FDA approval, but preliminary research has shown Evusheld is effective for three to six months. Anderson expects a booster dose to be advised within the next few months.
Treatment with Evusheld requires a physician's order. Most eligible people have specialists, such as oncologists or rheumatologists, they should consult before receiving the treatment. People who are eligible but are not current St. Luke's patients can contact the St. Luke's for more information.
Anderson and Shultz said even though cases in the Northland are relatively low, COVID-19 is still circulating. They said now is a good time for eligible patients to receive Evusheld because cases are at a more manageable level, but a new surge can begin at any moment.
“Waiting until a surge comes and then trying to get this is less ideal than getting it now and being protected for the next three to six months, regardless of what ends up happening with the pandemic,” Anderson said.
