Baystate Health is the only health system in our area to offer monoclonal antibody therapy for patients. This therapy can may help the body’s immune system to combat the deadly COVID-19 virus.
“We first administered the experimental drug to a patient on December 9. I was amazed by his recovery and absolutely thrilled over the hope that this could bring to so many other patients impacted by COVID-19,” said Dr. Gladys Fernandez, co-director of the Baystate Infection Control Treatment Unit (ICTU) and director of Hospital-Based Education Programs at Baystate Medical Center.
“Over the past two months, an incredible team of frontline healthcare providers and critical behind the scenes staff has come together to develop and implement an effective program of antibody infusions for patients across the state,” she added.
Emergency Use Authorization
The US Food and Drug Administration in November issued an emergency use authorization (EUA) for Eli Lilly’s monoclonal antibody and Regeneron's antibody “cocktail” to treat COVID-19 in high-risk patients with mild to moderate disease.
According to the FDA, the monoclonal antibody may reduce COVID-19-related hospitalizations and emergency room visits in some patients treated early on in their infection (within 10 days of symptom onset).
Emergency use authorization – which has since been invoked for the coronavirus vaccines – allows products such as the COVID-19 monoclonal antibodies which have been shown to offer benefits to some patients in trials, to be used before all the evidence is available for full approval.
What are monoclonal antibodies, and how are they used to treat COVID?
Unlike the vaccines that stimulate one’s own immune system to produce antibodies, monoclonal antibodies are given to treat early COVID-19 to help prevent progression of illness. They are also being studied to determine if they can prevent someone from contracting the coronavirus.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. The four laboratory-produced COVID-19 monoclonal antibodies – casirivimab, imdevimab, bamlanivimab, and etesevimab – are specifically directed against the spike protein of SARS-CoV-2 (the official name of the novel coronavirus) designed to block the virus’ attachment and entry into human cells. Bamlanivimab and the antibody cocktail casirivimab and imdevimab (referred to as a “cocktail” because of the combining of two antibodies) were first authorized in November 2020.
Both required one-hour infusion and an extra hour for observation following the infusion. On February 9, 2021, the cocktail bamlanivimab and etesevimab received FDA authorization after its phase 3 clinical data were analyzed to be infused for as short as 21 minutes.
"When used to treat COVID-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks," wrote the FDA.
Who is eligible for monoclonal antibody therapy?
The “authorized population” consists of patients ages 12 and older weighing about 88 pounds with positive results of direct SARS-CoV-2 testing and who are at high risk for progressing to severe COVID-19.
According to the FDA, “it should be given as soon as possible after a positive test result." This includes those who are 65 years of age or older who have certain chronic medical conditions such as diabetes, heart disease or kidney disease.
The cocktail has not been authorized for use in patients who are hospitalized with COVID-19 or need oxygen therapy due to the virus.
Jim Ryan first to receive therapy at Baystate
Jim Ryan, 69, was the first patient to receive a monoclonal antibody infusion at Baystate Medical Center.
“I am very cautious, and I emphasize ‘very’ cautious in following all of the safety guidelines. And it is undetermined where and from whom I might have caught the virus,” said the Ludlow man.
Ryan, a runner who competes in marathons, thought because he was healthy for his age that if he did contract the virus that it would be a mild case. But that wasn’t to be.
“I was pretty sick. My sinuses were involved. I lost my sense of taste and smell. And I had a 104-degree fever and was fatigued beyond belief. I was in communication from home with my primary care provider, who told me that Baystate Medical Center would soon be offering monoclonal antibody therapy to patients. Because of my age and the fact that I was considered high risk, she entered me into the lottery and within a few days I ‘won’ and was being infused at the hospital,” he said.
Recommends therapy for others
Because he was already pretty sick when he received the infusion, Ryan said, “It wasn’t an overnight cure. But I did start feeling better each day afterwards and it helped to keep me out of the hospital.”
“I would recommend the therapy to anyone given the opportunity to take it,” said Ryan, a retired pharmacist, who is healthy once again and riding his bicycle 25 miles a day.
Dr. Armando Paez, chief of the Infectious Disease Division at Baystate Medical Center, who also heads the Baystate COVID Monoclonal Antibody Infusion (MAI) Team, noted he was ecstatic to learn that the Massachusetts Department of Public Health (MDPH) had approved the hospital to provide the novel treatment to eligible COVID-19 patients in western Massachusetts.
A complicated, time-consuming process
“Not all hospitals are equipped to administer monoclonal antibody therapy, which is a complicated, time-consuming process that requires detailed attention and follow up from highly-skilled professionals. Our work would not have been as successful from an operational standpoint without the effort of an amazing group of dedicated individuals working behind the scenes on the screening, scheduling, treatment and follow up of these patients,” said Dr. Paez, who noted they have received a lot of positive feedback from patients on how they felt after receiving the therapy with few to no side effects.
Baystate’s chief Infectious disease physician noted COVID-19 monoclonal antibodies remain an investigational treatment, but are very promising in early infection and may also prevent infection following an exposure.
“Clinical studies are still being conducted, and so far, I like what I have been hearing. The challenge remains the complexity of how this treatment is being given by infusion, but subcutaneous (injected to skin) delivery of this treatment is currently being studied. Based on our experience, getting a COVID-19 test done in a high-risk patient suspected of having the virus and getting results promptly is as important as treating the patient as early as possible (up to 10 days from start of symptoms) to allow the cocktail’s potential benefit,” said Dr. Paez.
Meeting the demand
To date, the Baystate team has successfully provided monoclonal antibody treatment to over 140 patients selected for infusion based on a regulated criterion-based referral lottery system with guidance from the Massachusetts Department of Public Health. The allocation guidance prioritizes patients age ≥ 65 years and those age ≥ 18 years with obesity (BMI ≥ 35) and sets aside at least 20% of infusion slots for vulnerable populations.
Dr. Paez noted that the lottery system is not used any longer for patients to be considered to receive antibody therapy.
“Fortunately, Baystate is able to meet the demand for the monoclonal antibody treatment for eligible patients, and will only employ a lottery system if the demand exceeds the infusion capacity,” he said.
Eight patients per day
Since the program started at Baystate, the hospital has been able to successfully infuse up to 8 patients per day due to an efficient workflow and enhanced patient care strategies in place, noted Dr. Fernandez.
“I am very proud to be part of this team and reflect on the impact of this effort on the many patients treated every single day. The evolution of science and public health initiatives related to this pandemic has been overwhelming at times, and I consider it an honor and a blessing to be part of positive outcomes,” she added.
For more information
Learn more about the COVID-19 monoclonal antibody treatment at Baystate Health.