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Newly updated COVID-19 vaccination guidance from the American College of Rheumatology offers detailed insight into how clinicians should proceed with use, timing, and prioritization of COVID-19 vaccines in patients with rheumatic and musculoskeletal diseases (RMDs).
“The task force advised health care providers to avoid being overly dogmatic in following these recommendations,” Jeffrey R. Curtis, MD, of the University of Alabama at Birmingham, and colleagues wrote. “The attempt to optimize vaccine response in relation to the use and timing of immunosuppressive medications should not compromise a willing patient’s ability to undergo vaccination in a timely manner and risk a missed vaccination opportunity.” The guidelines were published in Arthritis & Rheumatology.
To review the published literature and determine the safety and efficacy of the available COVID-19 vaccines for patients with RMDs, a task force made up of nine rheumatologists/immunologists, two infectious disease specialists, and two public health physicians was formed. The ACR COVID-19 Vaccine Guidance Task Force considered vaccine clinical trial data and overall COVID-19 risk and outcomes among RMD patients, along with the immunogenicity of other vaccines in patients on immunomodulatory therapies and the safety profile of non-COVID vaccines in RMD patients.
Using a 9-point numeric scoring system, the task force developed 74 draft guidance statements that were rated with a median score of 7, 8, or 9. Consensus was deemed strong for 16 of the statements and moderate for the remaining 58.
Of the general considerations related to COVID-19 vaccination, the only statement to achieve strong consensus called for the rheumatology health care provider to take responsibility for assessing their patients’ COVID-19 vaccination status. Other notable statements asserted that patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at higher risk for hospitalized COVID-19, compared with the general population, and should be prioritized for vaccination accordingly, even though a risk for disease flare or worsening exists and the expected vaccine response for patients on systemic immunomodulatory therapies is “likely to be blunted in its magnitude and duration.”
Takeaway advice
When asked about a top-line takeaway for rheumatologists, Dr. Curtis replied: “Make sure that your patients are getting vaccinated. Even though the vaccine in patients with compromised immune systems might not work quite as well and might not last quite as long, they still should get vaccinated. And vaccine hesitancy is a real thing.”
Citing unpublished survey data, he estimated that roughly 25% of people with rheumatic conditions remain unvaccinated, and more than half of them said they had no vaccination plans. “That’s a pretty important message when up to a quarter of your higher-risk people take a pass,” he said. “You’d expect it to be better in people at risk who are on steroids or immune medications. That’s something rheumatologists can help with the most.”
Regarding vaccine use, the task force strongly recommended that RMD patients be offered COVID-19 vaccinations consistent with the emergency use authorization’s current age restrictions and/or Food and Drug Administration approval. They also strongly recommended patients with AIIRDs receive the second dose of a multidose vaccine, even if the first dose led to nonserious adverse events, and that health care providers avoid ordering lab testing to assess COVID-19 immunity in vaccinated and unvaccinated patients.
The issues around testing for immunity are ample, Dr. Curtis said. For starters, “there are different antibodies, and one of them wouldn’t be expected to go up after vaccination.” And even if you are testing for the correct antibodies, “now I get a number. Is my number high enough that says that I’m protected? That’s what clinicians want, that’s what patients want. Unfortunately, we don’t have that test. There’s an antibody test; you can test against the spike protein and get a number, but whether that number has clinical relevance that says you’re protected, and how much, and for how long, we definitely don’t have that information. You could be falsely reassured or falsely alarmed by the results.”
This statement, he added, has been particularly divisive. “A bunch of rheumatologists have said to me: ‘Look, we’re doing this routinely for our patients.’ My rejoinder was: ‘That’s great to know; what’s the evidence base for what you’re doing there? Because I haven’t read that paper.’ I fully acknowledge that, in groups of patients on certain therapies, the antibody response seems somewhat lower. But doctors don’t treat groups of patients; we treat patients one at a time. And I want to know how to help the patient in front of me, and I want to know what to tell him or her if I get the results of an antibody test.”
Finally, the task force emphasized that all AIIRD patients should receive the COVID-19 vaccinations, exempting only those with life-threatening disease, and they stated no preference for one COVID-19 vaccine over the other.
Vaccine choice
“Should you prefer one vaccine or vaccine platform to another? That’s been incredibly controversial,” Dr. Curtis said. Though the efficacy of the mRNA vaccines is often cited at 90%, compared with the roughly 60%-70% efficacy of the Johnson and & Johnson single-dose vaccine, “they’re not head-to-head studies. They weren’t done in the same countries; they weren’t done with the same viral variants. They’re not being evaluated under similar conditions; it’s not fair to hold them up and say: ‘Apples to apples, this one is better than that one.’ ”
“On the other hand,” he added, “if you were choosing, which would you want? If you are given a choice, you’re probably going to have a preference. The downside for a public health group – this group, which is trying to help rheumatologists and their patients make prudent decisions in light of very imperfect and evolving evidence – is that most people don’t have a choice. So if you send the message that one vaccine might be better than another, if that makes people wait for the one that supposedly might be better, you’ve probably done something bad. They’re delaying for what may be a marginal reason, and some vaccine protection is better than no vaccine protection.”
Regarding vaccination timing in patients who are on immunomodulatory therapies, the task force strongly recommended not delaying or adjusting the timing for anyone on hydroxychloroquine, sulfasalazine, leflunomide, apremilast, or intravenous immunoglobulin. They moderately recommended the same for patients on numerous drugs, including methotrexate, tumor necrosis factor inhibitors, Janus kinase inhibitors, abatacept, and glucocorticoids. Patients on rituximab with a low COVID-19 risk were recommended to schedule their vaccination so that the vaccine series is initiated roughly 4 weeks before their next scheduled rituximab cycle.
Regarding the use and timing of immunomodulatory therapies in relation to vaccination, they strongly recommended no modifications for patients on hydroxychloroquine, apremilast, intravenous immunoglobulin, or glucocorticoids. They also moderately recommended no modifications for patients on numerous drugs, including sulfasalazine, leflunomide, azathioprine, oral cyclophosphamide, and TNF inhibitors.
Regarding limitations, the researchers noted that there is no direct evidence about COVID-19 vaccine safety and efficacy yet in this subset of patients. They also acknowledged that they did not follow the rigorous methodology typically used by the ACR in developing formal clinical practice guidelines, calling it an “expected limitation” given the need to issue timely and potentially lifesaving guidance for the rheumatology community.
The authors acknowledged several potential conflicts of interest, including receiving consulting fees, speaking fees, and research grants from various pharmaceutical companies.
Newly updated COVID-19 vaccination guidance from the American College of Rheumatology offers detailed insight into how clinicians should proceed with use, timing, and prioritization of COVID-19 vaccines in patients with rheumatic and musculoskeletal diseases (RMDs).
“The task force advised health care providers to avoid being overly dogmatic in following these recommendations,” Jeffrey R. Curtis, MD, of the University of Alabama at Birmingham, and colleagues wrote. “The attempt to optimize vaccine response in relation to the use and timing of immunosuppressive medications should not compromise a willing patient’s ability to undergo vaccination in a timely manner and risk a missed vaccination opportunity.” The guidelines were published in Arthritis & Rheumatology.
To review the published literature and determine the safety and efficacy of the available COVID-19 vaccines for patients with RMDs, a task force made up of nine rheumatologists/immunologists, two infectious disease specialists, and two public health physicians was formed. The ACR COVID-19 Vaccine Guidance Task Force considered vaccine clinical trial data and overall COVID-19 risk and outcomes among RMD patients, along with the immunogenicity of other vaccines in patients on immunomodulatory therapies and the safety profile of non-COVID vaccines in RMD patients.
Using a 9-point numeric scoring system, the task force developed 74 draft guidance statements that were rated with a median score of 7, 8, or 9. Consensus was deemed strong for 16 of the statements and moderate for the remaining 58.
Of the general considerations related to COVID-19 vaccination, the only statement to achieve strong consensus called for the rheumatology health care provider to take responsibility for assessing their patients’ COVID-19 vaccination status. Other notable statements asserted that patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at higher risk for hospitalized COVID-19, compared with the general population, and should be prioritized for vaccination accordingly, even though a risk for disease flare or worsening exists and the expected vaccine response for patients on systemic immunomodulatory therapies is “likely to be blunted in its magnitude and duration.”
Takeaway advice
When asked about a top-line takeaway for rheumatologists, Dr. Curtis replied: “Make sure that your patients are getting vaccinated. Even though the vaccine in patients with compromised immune systems might not work quite as well and might not last quite as long, they still should get vaccinated. And vaccine hesitancy is a real thing.”
Citing unpublished survey data, he estimated that roughly 25% of people with rheumatic conditions remain unvaccinated, and more than half of them said they had no vaccination plans. “That’s a pretty important message when up to a quarter of your higher-risk people take a pass,” he said. “You’d expect it to be better in people at risk who are on steroids or immune medications. That’s something rheumatologists can help with the most.”
Regarding vaccine use, the task force strongly recommended that RMD patients be offered COVID-19 vaccinations consistent with the emergency use authorization’s current age restrictions and/or Food and Drug Administration approval. They also strongly recommended patients with AIIRDs receive the second dose of a multidose vaccine, even if the first dose led to nonserious adverse events, and that health care providers avoid ordering lab testing to assess COVID-19 immunity in vaccinated and unvaccinated patients.
The issues around testing for immunity are ample, Dr. Curtis said. For starters, “there are different antibodies, and one of them wouldn’t be expected to go up after vaccination.” And even if you are testing for the correct antibodies, “now I get a number. Is my number high enough that says that I’m protected? That’s what clinicians want, that’s what patients want. Unfortunately, we don’t have that test. There’s an antibody test; you can test against the spike protein and get a number, but whether that number has clinical relevance that says you’re protected, and how much, and for how long, we definitely don’t have that information. You could be falsely reassured or falsely alarmed by the results.”
This statement, he added, has been particularly divisive. “A bunch of rheumatologists have said to me: ‘Look, we’re doing this routinely for our patients.’ My rejoinder was: ‘That’s great to know; what’s the evidence base for what you’re doing there? Because I haven’t read that paper.’ I fully acknowledge that, in groups of patients on certain therapies, the antibody response seems somewhat lower. But doctors don’t treat groups of patients; we treat patients one at a time. And I want to know how to help the patient in front of me, and I want to know what to tell him or her if I get the results of an antibody test.”
Finally, the task force emphasized that all AIIRD patients should receive the COVID-19 vaccinations, exempting only those with life-threatening disease, and they stated no preference for one COVID-19 vaccine over the other.
Vaccine choice
“Should you prefer one vaccine or vaccine platform to another? That’s been incredibly controversial,” Dr. Curtis said. Though the efficacy of the mRNA vaccines is often cited at 90%, compared with the roughly 60%-70% efficacy of the Johnson and & Johnson single-dose vaccine, “they’re not head-to-head studies. They weren’t done in the same countries; they weren’t done with the same viral variants. They’re not being evaluated under similar conditions; it’s not fair to hold them up and say: ‘Apples to apples, this one is better than that one.’ ”
“On the other hand,” he added, “if you were choosing, which would you want? If you are given a choice, you’re probably going to have a preference. The downside for a public health group – this group, which is trying to help rheumatologists and their patients make prudent decisions in light of very imperfect and evolving evidence – is that most people don’t have a choice. So if you send the message that one vaccine might be better than another, if that makes people wait for the one that supposedly might be better, you’ve probably done something bad. They’re delaying for what may be a marginal reason, and some vaccine protection is better than no vaccine protection.”
Regarding vaccination timing in patients who are on immunomodulatory therapies, the task force strongly recommended not delaying or adjusting the timing for anyone on hydroxychloroquine, sulfasalazine, leflunomide, apremilast, or intravenous immunoglobulin. They moderately recommended the same for patients on numerous drugs, including methotrexate, tumor necrosis factor inhibitors, Janus kinase inhibitors, abatacept, and glucocorticoids. Patients on rituximab with a low COVID-19 risk were recommended to schedule their vaccination so that the vaccine series is initiated roughly 4 weeks before their next scheduled rituximab cycle.
Regarding the use and timing of immunomodulatory therapies in relation to vaccination, they strongly recommended no modifications for patients on hydroxychloroquine, apremilast, intravenous immunoglobulin, or glucocorticoids. They also moderately recommended no modifications for patients on numerous drugs, including sulfasalazine, leflunomide, azathioprine, oral cyclophosphamide, and TNF inhibitors.
Regarding limitations, the researchers noted that there is no direct evidence about COVID-19 vaccine safety and efficacy yet in this subset of patients. They also acknowledged that they did not follow the rigorous methodology typically used by the ACR in developing formal clinical practice guidelines, calling it an “expected limitation” given the need to issue timely and potentially lifesaving guidance for the rheumatology community.
The authors acknowledged several potential conflicts of interest, including receiving consulting fees, speaking fees, and research grants from various pharmaceutical companies.
Newly updated COVID-19 vaccination guidance from the American College of Rheumatology offers detailed insight into how clinicians should proceed with use, timing, and prioritization of COVID-19 vaccines in patients with rheumatic and musculoskeletal diseases (RMDs).
“The task force advised health care providers to avoid being overly dogmatic in following these recommendations,” Jeffrey R. Curtis, MD, of the University of Alabama at Birmingham, and colleagues wrote. “The attempt to optimize vaccine response in relation to the use and timing of immunosuppressive medications should not compromise a willing patient’s ability to undergo vaccination in a timely manner and risk a missed vaccination opportunity.” The guidelines were published in Arthritis & Rheumatology.
To review the published literature and determine the safety and efficacy of the available COVID-19 vaccines for patients with RMDs, a task force made up of nine rheumatologists/immunologists, two infectious disease specialists, and two public health physicians was formed. The ACR COVID-19 Vaccine Guidance Task Force considered vaccine clinical trial data and overall COVID-19 risk and outcomes among RMD patients, along with the immunogenicity of other vaccines in patients on immunomodulatory therapies and the safety profile of non-COVID vaccines in RMD patients.
Using a 9-point numeric scoring system, the task force developed 74 draft guidance statements that were rated with a median score of 7, 8, or 9. Consensus was deemed strong for 16 of the statements and moderate for the remaining 58.
Of the general considerations related to COVID-19 vaccination, the only statement to achieve strong consensus called for the rheumatology health care provider to take responsibility for assessing their patients’ COVID-19 vaccination status. Other notable statements asserted that patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at higher risk for hospitalized COVID-19, compared with the general population, and should be prioritized for vaccination accordingly, even though a risk for disease flare or worsening exists and the expected vaccine response for patients on systemic immunomodulatory therapies is “likely to be blunted in its magnitude and duration.”
Takeaway advice
When asked about a top-line takeaway for rheumatologists, Dr. Curtis replied: “Make sure that your patients are getting vaccinated. Even though the vaccine in patients with compromised immune systems might not work quite as well and might not last quite as long, they still should get vaccinated. And vaccine hesitancy is a real thing.”
Citing unpublished survey data, he estimated that roughly 25% of people with rheumatic conditions remain unvaccinated, and more than half of them said they had no vaccination plans. “That’s a pretty important message when up to a quarter of your higher-risk people take a pass,” he said. “You’d expect it to be better in people at risk who are on steroids or immune medications. That’s something rheumatologists can help with the most.”
Regarding vaccine use, the task force strongly recommended that RMD patients be offered COVID-19 vaccinations consistent with the emergency use authorization’s current age restrictions and/or Food and Drug Administration approval. They also strongly recommended patients with AIIRDs receive the second dose of a multidose vaccine, even if the first dose led to nonserious adverse events, and that health care providers avoid ordering lab testing to assess COVID-19 immunity in vaccinated and unvaccinated patients.
The issues around testing for immunity are ample, Dr. Curtis said. For starters, “there are different antibodies, and one of them wouldn’t be expected to go up after vaccination.” And even if you are testing for the correct antibodies, “now I get a number. Is my number high enough that says that I’m protected? That’s what clinicians want, that’s what patients want. Unfortunately, we don’t have that test. There’s an antibody test; you can test against the spike protein and get a number, but whether that number has clinical relevance that says you’re protected, and how much, and for how long, we definitely don’t have that information. You could be falsely reassured or falsely alarmed by the results.”
This statement, he added, has been particularly divisive. “A bunch of rheumatologists have said to me: ‘Look, we’re doing this routinely for our patients.’ My rejoinder was: ‘That’s great to know; what’s the evidence base for what you’re doing there? Because I haven’t read that paper.’ I fully acknowledge that, in groups of patients on certain therapies, the antibody response seems somewhat lower. But doctors don’t treat groups of patients; we treat patients one at a time. And I want to know how to help the patient in front of me, and I want to know what to tell him or her if I get the results of an antibody test.”
Finally, the task force emphasized that all AIIRD patients should receive the COVID-19 vaccinations, exempting only those with life-threatening disease, and they stated no preference for one COVID-19 vaccine over the other.
Vaccine choice
“Should you prefer one vaccine or vaccine platform to another? That’s been incredibly controversial,” Dr. Curtis said. Though the efficacy of the mRNA vaccines is often cited at 90%, compared with the roughly 60%-70% efficacy of the Johnson and & Johnson single-dose vaccine, “they’re not head-to-head studies. They weren’t done in the same countries; they weren’t done with the same viral variants. They’re not being evaluated under similar conditions; it’s not fair to hold them up and say: ‘Apples to apples, this one is better than that one.’ ”
“On the other hand,” he added, “if you were choosing, which would you want? If you are given a choice, you’re probably going to have a preference. The downside for a public health group – this group, which is trying to help rheumatologists and their patients make prudent decisions in light of very imperfect and evolving evidence – is that most people don’t have a choice. So if you send the message that one vaccine might be better than another, if that makes people wait for the one that supposedly might be better, you’ve probably done something bad. They’re delaying for what may be a marginal reason, and some vaccine protection is better than no vaccine protection.”
Regarding vaccination timing in patients who are on immunomodulatory therapies, the task force strongly recommended not delaying or adjusting the timing for anyone on hydroxychloroquine, sulfasalazine, leflunomide, apremilast, or intravenous immunoglobulin. They moderately recommended the same for patients on numerous drugs, including methotrexate, tumor necrosis factor inhibitors, Janus kinase inhibitors, abatacept, and glucocorticoids. Patients on rituximab with a low COVID-19 risk were recommended to schedule their vaccination so that the vaccine series is initiated roughly 4 weeks before their next scheduled rituximab cycle.
Regarding the use and timing of immunomodulatory therapies in relation to vaccination, they strongly recommended no modifications for patients on hydroxychloroquine, apremilast, intravenous immunoglobulin, or glucocorticoids. They also moderately recommended no modifications for patients on numerous drugs, including sulfasalazine, leflunomide, azathioprine, oral cyclophosphamide, and TNF inhibitors.
Regarding limitations, the researchers noted that there is no direct evidence about COVID-19 vaccine safety and efficacy yet in this subset of patients. They also acknowledged that they did not follow the rigorous methodology typically used by the ACR in developing formal clinical practice guidelines, calling it an “expected limitation” given the need to issue timely and potentially lifesaving guidance for the rheumatology community.
The authors acknowledged several potential conflicts of interest, including receiving consulting fees, speaking fees, and research grants from various pharmaceutical companies.
FROM ARTHRITIS & RHEUMATOLOGY