ACR COVID-19 Vaccine Guidance Recommends Vaccination, Addresses Immunosuppressant Drugs & Patient Concerns February 11, 2021 ATLANTA – The American College of Rheumatology (ACR) has released its COVID-19 Vaccine Clinical Guidance Summary that provides an official recommendation to vaccinate rheumatology patients with musculoskeletal, inflammatory and autoimmune diseases. “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,” said Dr. Jeffrey Curtis, chair of the ACR COVID-19 Vaccine Clinical Guidance Task Force. “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 guidance was developed by a multi-disciplinary panel of nine rheumatologists, two infectious disease specialists, and two public health experts and is intended to give direction to providers treating rheumatology patients on how to best use COVID-19 vaccines, as well as facilitate implementation of vaccination strategies for rheumatology patients. “Our members have been inundated with questions and concerns from their patients on whether they should receive the vaccine,” said Dr. David Karp, President of the ACR. “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.” Important considerations and caveats on how to approach vaccination are included for patients with high disease activity and/or those taking immunosuppressant treatments. These include recommendations to modify certain treatments such as methotrexate, JAK inhibitors (e.g., baricitinib, tofacitinib, upadacitinib) and some biologics (e.g., abatacept and rituximab) that alter the immune system’s response in ways that might affect vaccine response. The panel based their recommendations on the use and timing of immunomodulatory medications on evidence extrapolated from their immunologic effects as they relate to other vaccines and vaccine types. As such, these and other recommendations made by the task force should be considered ‘conditional.’ “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 (e.g., high dose steroids),” said Curtis. “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. 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.” "For example, an RA patient with well-controlled disease may benefit from holding a dose of methotrexate immediately following vaccination," added Karp. “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.” Given the uncertainty surrounding when alternative vaccine types will become available, the task force focused on the two mRNA COVID-19 vaccines available in the U.S. at the time of their deliberation. No preference for one vaccine over another was stated, and patients are recommended to receive whichever of the mRNA vaccines is available to them. “With efficacy about the same for both vaccines, we felt it was not important which brand patients received. 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,” stated Curtis. The ACR has voiced that recommendations in the guidance should not replace clinical judgement, and decisions about individual patients should be made as part of shared decision-making with patients that considers their underlying health condition(s), disease activity level, current treatments, risk of exposure to SARS-CoV-2 and geography. Patients are also encouraged to continue following all public health guidelines regarding mask wearing, physical distancing and other preventive measures even after vaccination. Future changes are expected to the guidance as more safety and efficacy data about the existing two mRNA vaccines, other vaccine platforms, and vaccine response specific to rheumatic disease patients become available. “This is very much a ‘living document,’ and the task force already has plans to evaluate additional data in the coming weeks,” said Curtis. “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 is hosting a town hall with members of the task force on Tuesday, Feb. 16, at 7:30 PM ET to discuss the guidance and answer questions about the recommendations. Members of the press are invited to attend and encouraged to register online. Questions about the guidance can be submitted when registering. A peer-reviewed manuscript with additional details on the clinical studies, data, and discussion points that influenced the recommendations has been submitted for publication to Arthritis & Rheumatology. It will be made available on the ACR website once published. Media Contact: Jocelyn Givensjgivens@rheumatology.org404-929-4810 ###The American College of Rheumatology (ACR) is an international medical society representing over 7,700 rheumatologists and rheumatology health professionals with a mission to empower rheumatology professionals to excel in their specialty. In doing so, the ACR offers education, research, advocacy and practice management support to help its members continue their innovative work and provide quality patient care. Rheumatologists are experts in the diagnosis, management and treatment of more than 100 different types of arthritis and rheumatic diseases.