Calabrese to rheumatologists on COVID-19 breakthrough cases: 'Those are our patients'
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Rheumatologists need to start focusing on their fully vaccinated patients with breakthrough COVID-19 cases, and begin referring them for monoclonal treatment, according to Leonard Calabrese, DO.
Addressing attendees at the 2021 Association of Women in Rheumatology Annual Conference, Calabrese cited a study published in Clinical Microbiology and Infection, which reported on 152 breakthrough COVID-19 cases in which the patient was hospitalized and found that 40% were immunocompromised.
“Those are our patients,” said Calabrese, a professor of medicine at the Cleveland Clinic Lerner College of Medicine and RJ Fasenmyer chair of the Center for Clinical Immunology at Cleveland Clinic. “There are also solid-organ transplants and cancer, but that’s why this is the real deal.”
Stressing this point, he then “challenged” those listening to give more attention to patients with breakthrough cases.
“I challenge you all to focus on your vaccine breakthrough patients now,” he said. “We take care of that 3% of patients who break through.”
He later added: “For every one of you who has a patient tomorrow who has lupus, outpatient, on high-risk immunosuppressive drugs — do you know how to refer those patients for monoclonal antibody therapy within 10 days of symptoms? I challenge you, I challenge you.”
According to published reports, the top five symptoms experienced by fully vaccinated patients with breakthrough COVID-19 cases are headache, runny nose, sneezing, sore throat and loss of smell.
However, not all patients with breakthrough COVID-19 will have all of these symptoms at once.
“My personal story: When I came back from Florida Society of Rheumatology [Annual Meeting], I had runny nose, sore throat and a headache,” Calabrese recalled of his own breakthrough COVID-19 case. “I wasn’t sneezing and I didn’t have loss of smell. But I didn’t think of this as a breakthrough until 5 days later.”
For these patients, there are three authorized monoclonal drug cocktails: casirivimab and imdevimab (Regeneron), administered together; bamlanivimab and etesevimab (Eli Lilly & Co.), administered together; and sotrovimab (VIR-7831, GlaxoSmithKline). All are authorized for emergency use by the FDA. However, the bamlanivimab/etesevimab cocktail has “been on pause” since the end of June over questions regarding its effectiveness against COVID-19 variants, Calabrese noted.
“Yes, our patients are candidates for these,” he said. “They merely have to have symptoms and be within 10 days, but you got to get them in.”
In addition, the Regeneron cocktail, or REGEN-COV, has been approved by the FDA for postexposure prophylaxis in immunocompromised patients.
“So, when you get a call tomorrow that that lupus patient, or your rheumatoid arthritis patient, who’s been on rituximab, ask yourself: Are they high risk? Yes, because they are on one of these drugs,” Calabrese said. “Secondly, are they fully vaccinated? That would qualify them as well. And finally, have they been vaccinated, but are they at high risk for not responding to that vaccine? I would say someone on high-dose prednisone, rituximab and many other combinations would fit the bill. Also, what has that patient told you?”
“‘My husband just came home, and he’s been diagnosed with COVID-19. I feel fine right now but what should I do?’” he added, describing a hypothetical situation. “You immediately plug them in through your local health care system to get preventive therapy, just like you would be giving immunoglobulin to patients with CVID. There’s more to it than meets the eye, but we’re just starting to launch this in our own health care system, and this is only a week or 2 old.”
Calabrese also urged rheumatologists to report their breakthrough cases to the COVID-19 Global Rheumatology Alliance.
“We are launching a study as well of breakthrough infections, and hopefully we may be able to partner with AWIR on looking at your cases,” he said.
According to Calabrese, all patients with immune-mediated diseases should be immunized. Safety among these patients appears no different than the general population, but rare, largely transient autoimmune or auto-inflammatory syndromes have been reported, he added.
“They are extremely rare, and the benefits outweigh the risks,” Calabrese said.
In addition, he stated that patients should be counseled that their therapies — notably rituximab (Rituxan; Genentech, Biogen), but also possibly JAK inhibitors, intravenous abatacept, high-dose glucocorticoids and methotrexate — may impede COVID-19 vaccine response.
“Certainly, that is why all of these people are eligible for boosters,” Calabrese said. “And patients should be counseled that they are not going to be as well-vaccinated as healthy people their age and gender. That means nonpharmacologic implications, such as masking — don’t go to that stupid cousin’s wedding, and you’re not going to Disney World. Just hunker down for a while until this thing turns around.”
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Calabrese L. COVID-19: An Immunology Bootcamp. Presented at: Association of Women in Rheumatology Annual Conference; August 12-15, 2021, Hilton Head Island, South Carolina (hybrid meeting).
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