ACR: Patients with rheumatic disease should receive COVID-19 vaccine 'as soon as possible'
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Patients with non-life-threatening autoimmune and inflammatory rheumatic conditions should be vaccinated for COVID-19 as soon as possible regardless of disease activity or severity, according to new American College of Rheumatology guidance.
The call for timely inoculations among the rheumatic population is just one in a sprawling list of 74 draft guidance statements published by the ACR in Arthritis & Rheumatology regarding COVID-19 vaccination. Altogether, the document — which is subject to change as more data become available — includes voluntary guidance on which patients can receive the vaccine without delay, based on disease severity and medication, and which drug regimens should be modified before and after receiving the vaccine.
“Given the role that rheumatology providers have in serving patients with rheumatic and musculoskeletal diseases (RMD), particularly those with autoimmune and inflammatory rheumatic diseases (AIIRD), there is an urgent need to optimize strategies to curb the incidence of COVID-19,” Jeffrey R. Curtis, MD, MS, MPH, of the University of Alabama at Birmingham, the lead author of the guidance, and colleagues wrote.
“In addition to preventive measures such as physical distancing, mask-wearing, handwashing, and shelter-in-place orders, the newly available COVID-19 vaccines provide a powerful tool to mitigate the burgeoning growth of adverse outcomes resulting from COVID-19,” they added.
Guidance Based on Current Evidence
To offer guidance to rheumatology providers regarding COVID-19 vaccines in patients with rheumatic and musculoskeletal diseases, the ACR began assembling its COVID-19 Vaccination Guidance Task Force in October 2020. The 13-member task force included nine rheumatologists, two infectious disease specialists and two public health physicians currently or formerly with the CDC.
After agreeing on scoping questions during a teleconference in December 2020, members created an evidence report summarizing the available published literature public data regarding the efficacy and safety of the COVID-19 vaccines, as well as regarding other vaccines among patients with rheumatic and musculoskeletal diseases.
Due to the accelerated time frame the members of the task force found themselves under, they opted to conduct a nonsystematic evidence review, using PubMed searchers and data from the CDC and FDA. In addition, due to the dearth of available information and direct evidence regarding COVID-19 vaccination among patients with rheumatic and musculoskeletal diseases, the members wrote they were forced to extrapolate based on literature for other vaccines.
After drafting consensus statements, task force members rated their agreement on each based on a 1-9 numerical scale, using a modified Delphi process and the RAND/UCLA appropriateness method, with refinement and iteration over two sessions in January. The ACR Board of Directors approved the guidance on Feb. 8. Following its publication, an ACR project librarian began regularly refreshing the literature search and will send new articles to the task force for review, with the aim of updating the document as new evidence becomes available.
Patients with Rheumatic Disease Take Priority
According to the approved guidance, patients with autoimmune and inflammatory rheumatic conditions should be prioritized for vaccination ahead of nonprioritized individuals in the general population of similar age and sex. In addition, although the document states that a theoretical risk exists for autoimmune and inflammatory rheumatic flare or disease worsening after COVID-19 vaccination, that risk is outweighed by the benefits of inoculation.
However, the guidance also cautions that patients with life-threatening autoimmune and inflammatory rheumatic disease — those requiring ICU care for any reason, for example — should delay vaccination until their condition better controlled. In addition, patients with autoimmune and inflammatory rheumatic conditions who are not currently treated immunomodulatory treatments should receive their first vaccine dose prior to immunomodulatory initiation.
Further, the guidance suggests that no delay is necessary in vaccinating patients receiving hydroxychloroquine, sulfasalazine, leflunomide, apremilast (Otezla, Amgen), intravenous immunoglobulin, methotrexate, mycophenolate, azathioprine, intravenous or oral cyclophosphamide, TNF inhibitors, IL-6R, IL-1, IL17, IL-12/23 or IL-23 blockers, belimumab (Benlysta, GlaxoSmithKline), JAK inhibitors, intravenous or subcutaneous abatacept (Orencia, Bristol Myers Squibb), oral calcineurin inhibitors, or glucocorticoids at prednisone-equivalent doses of less than 20 mg per day.
The task force did not reach a consensus on patients receiving glucocorticoids at prednisone-equivalent doses of 20 mg per day or more.
For patients receiving rituximab (Rituxan, Genentech), COVID-19 vaccinations should be initiated approximately 4 weeks prior to the next scheduled rituximab cycle, assuming the individual’s risk for COVID-19 is low or can be reduced through self-isolation and other measures.
Recommendations Subject to Change
Regarding the timing and use of immunomodulatory therapies with the COVID-19 vaccine, the guidance suggests that methotrexate be held for 1 week after each vaccine dose for those with well-controlled disease. JAK inhibitors should also be held for 1 week after each dose. Meanwhile, subcutaneous abatacept should be held 1 week prior to and 1 week after the first vaccine dose only. Regarding intravenous abatacept, the first vaccination should occur 4 weeks after infusion, with subsequent infusions postponed for 1 week. with no modifications necessary for the second shot with either intravenous or subcutaneous abatacept.
Intravenous cyclophosphamide doses should be timed to occur approximately 1 week after each vaccine dose, when feasible. Lastly, rituximab should be delayed for 2 to 4 weeks after the second vaccine dose if disease activity allows.
Due to a lack of information and evidence, the task force opted to not include guidance on vaccinating children with rheumatic diseases.
“[This guidance] is intended to aid in the care of individual patients but not to supplant personalized care or constrain shared decision-making with patients,” Curtis and colleagues wrote. “The mRNA vaccine platform is novel, and considerations for vaccines developed on this platform may differ from those relevant for other vaccines. The guidance regarding the use and timing of immunomodulatory medications were based upon extrapolation of the available evidence of their immunologic effects as they relate to other vaccines and vaccine platforms.”
“As such, all of these recommendations are considered ‘conditional,’” they added. “Finally, the task force advised health care providers to avoid being overly dogmatic in following these recommendations. 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 fashion and risk a missed vaccination opportunity.”
Perspective
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As with everything related to COVID-19 over the past year, we are learning as we go, and have adjusted to being prepared to pivot at any moment. In health care, we are used to having evidence-based research to guide our practices, but with a novel virus and novel vaccines being created to protect against this virus, the evidence continues to evolve.
As a nurse in a very busy rheumatology practice, one of my key roles is to educate patients. When the vaccines first started to surface and become available to our patients, we had more questions than answers. We were extrapolating evidence based on prior vaccine guidelines, such as the influenza vaccine. It was another case of “we simply don’t know what we don’t know”. Patients don’t love to hear that!
As a member of the COVID vaccine task force for our office, I struggled with trying to come to some practice-wide consensus when it came to advising patients regarding the vaccine and their medications. When the ACR guidelines were released, there was a feeling of relief knowing that we finally had some consistent guidelines that we could implement into our practice. While it is understood that these are guidelines and that every patient is different, having these guidelines in place has made for a more efficient workflow.
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