ACR: Vaccinate patients with musculoskeletal, inflammatory, autoimmune disease for COVID-19
Rheumatology patients with musculoskeletal, inflammatory and autoimmune diseases should be vaccinated for COVID-19, according to newly released recommendations from the American College of Rheumatology.
“Although there is limited data from large population-based studies, it appears that patients with autoimmune and inflammatory conditions are at a higher risk for developing hospitalized COVID-19 compared to the general population and have worse outcomes associated with infection,” Jeffrey Curtis, MD, MS, MPH, of the University of Alabama at Birmingham, and chair of the ACR COVID-19 Vaccine Clinical Guidance Task Force, said in a press release.
He added: “Based on this concern, the benefit of COVID-19 vaccination outweighs any small, possible risks for new autoimmune reactions or disease flare after vaccination.”
The new clinical guidance, which is still pending journal peer review, is intended to provide direction to rheumatologists and other health professionals who treat patients with rheumatic diseases on how to best use COVID-19 vaccines. It also provides guidance on how to facilitate vaccination strategies for rheumatology patients. A draft summary of the guidance and recommendations was approved Feb. 8 by the ACR board of directors.
According to the ACR, the guidance is a product a multi-disciplinary panel of nine rheumatologists, two infectious disease specialists and two public health experts. This task force convened multiple times in December 2020 and January 2021, proposing and reviewing clinical questions as well as associated proposed vaccine guidance statements. Consensus building involved two rounds of asynchronous anonymous rating by email and two live webinars including the entire task force.
“There was vigorous debate on several topics such as the expected magnitude of benefit of vaccination for patients receiving therapies that substantially alter or suppress the immune system (eg, high-dose steroids),” Curtis said in the release.
“Ultimately, the task force agreed that in almost all cases, proceeding with vaccination and obtaining at least a partial response would be better than deferring vaccination, since deferring provides no protection at all,” he added. “Given the lack of direct evidence for these vaccines in rheumatology patients, the panel applied general immunologic principles observed with other vaccines to make recommendations on how to increase the likelihood of a favorable vaccine response.”
Navigating a Changing Landscape
The guidelines included important considerations and caveats on how to approach vaccination for patients with high disease activity, as well as those receiving immunosuppressant treatments. For example, the ACR recommends modifying certain treatments such as methotrexate, janus kinase inhibitors — such as baricitinib (Olumiant, Eli Lilly & Co.), tofacitinib (Xeljanz, Pfizer) and upadacitinib (Rinvoq, AbbVie) — and some biologics — abatacept (Orencia, Bristol Myers Squibb) and rituximab (Rituxan, Genentech) — that alter the immune system’s response in ways that might affect vaccine response.
“For example, an RA patient with well-controlled disease may benefit from holding a dose of methotrexate immediately following vaccination,” David Karp, MD, PhD, president of the ACR, said in the release. “In the case of drugs with long dosing intervals such as rituximab, there are some circumstances where it may be beneficial to time the vaccine around when the last dose was given to maximize the vaccine’s efficacy. We encourage clinicians to study the charts we’ve provided in the summary for details on how they can time various medications to ensure maximum success.”
The panel based its recommendations on the use, and timing, of immunomodulatory medications on evidence extrapolated from their immunologic effects related to other vaccines and vaccine types. As such, these and other recommendations made by the task force should be considered “conditional,” said the press release.
In addition, given the uncertainty surrounding when alternative vaccine types will be available, the task force focused on the two mRNA COVID-19 vaccines available in the United States at the time of their deliberation. The task force did not give any preference for one vaccine over another, and instead recommended patients receive whichever one is available to them.
“With efficacy about the same for both vaccines, we felt it was not important which brand patients received,” Curtis said in the release. “Realistically, many individuals will not have a choice, as availability varies by site and region. Therefore, it was important to assure providers and patients this was not a factor to consider when discussing vaccination. However, patients should stick to the same vaccine brand for both injections.”
Guidance given Available Data
The ACR cautioned that the recommendations are not intended to — and should not — replace clinical judgement. Decisions regarding individual patients should be made through shared decision-making with patients, considering their underlying health conditions, disease activity, current treatments, COVID-19 exposure risk and geography, the release said.
In addition, the ACR encouraged patients to continue following all public health guidelines regarding masks, social distancing and other preventive measures, even after vaccination.
The group also stressed that changes to the guidance are expected as additional safety and efficacy data become available.
“This is very much a ‘living document,’ and the task force already has plans to evaluate additional data in the coming weeks,” Curtis said in the release. “We desperately need direct evidence from high-quality research. To reach that goal, we would issue a call to action for patients, providers and researchers to mobilize and support the important research efforts that are underway to study vaccine effectiveness and safety in rheumatology patients.”
The ACR will host a town hall with members of the task force on Tuesday, Feb. 16, at 7:30 p.m. EST, to discuss the guidance and answer questions about the recommendations. Those planning to attend will be required to register online. Questions about the guidance can be submitted when registering.
“Our members have been inundated with questions and concerns from their patients on whether they should receive the vaccine,” Karp said in the release. “We hope the guidance will provide them evidence-based reassurance that their patients will benefit from being vaccinated and guidance on how to best incorporate it into their treatment plans to maximize vaccine efficacy.”