American College of Rheumatology Guidance for COVID‐19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 2

Abstract

Objective. To provide guidance to rheumatology providers on the use of coronavirus disease 2019 vaccines for patients with rheumatic and musculoskeletal diseases (RMDs).Methods. A task force was assembled that included 9 rheumatologists/immunologists, 2 infectious disease specialists, and 2 public health physicians. After agreeing on scoping questions, an evidence report was created that summarized the published literature and publicly available data regarding COVID-19 vaccine efficacy and safety, as well as literature for other vaccines in RMD patients. Task force members rated their agreement with draft consensus statements on a 9-point numerical scoring system, using a modified Delphi process and the RAND/University of California Los Angeles Appropriateness Method, with refinement and iteration over 2 sessions. Consensus was determined based on the distribution of ratings.Results. Despite a paucity of direct evidence, 74 draft guidance statements were developed by the task force and agreed upon with consensus to provide guidance for use of the COVID-19 vaccines in RMD patients and to offer recommendations regarding the use and timing of immunomodulatory therapies around the time of vaccination.Conclusion. These guidance statements, made in the context of limited clinical data, are intended to provide direction to rheumatology health care providers on how to best use COVID-19 vaccines and to facilitate implementation of vaccination strategies for RMD patients.Due to the rapidly expanding information and evolving evidence related to COVID-19, which may lead to modification of some guidance statements over time, it is anticipated that updated versions of this article will be published, with the version number included in the title. Readers should ensure that they are consulting the most current version. A summary of revisions over time and their location is included in the Supplementary Tables.Guidance developed and/or endorsed by the American College of Rheumatology (ACR) is intended to inform particular patterns of practice and not to dictate the care of a particular patient. The ACR considers adherence to this guidance to be voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances. Guidance statements are intended to promote beneficial or desirable outcomes but cannot guarantee any specific outcome. Guidance developed or endorsed by the ACR is subject to periodic revision as warranted by the evolution of medical knowledge, technology, and practice.

Anti-COVID-19 Vaccination in Patients with Autoimmune-Autoinflammatory Disorders and Primary/Secondary Immunodeficiencies: The Position of the Task Force on Behalf of the Italian Immunological Societies

“…JKI should be interrupted for one week after each vaccine dose. The last update of the ACR guidance was even more restrictive by introducing discontinuation of mycophenolate for one week following each vaccine dose and of acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) 24 h prior to vaccination [106]. However, the limits on the use of immunosuppressive drugs in the vaccination period have been based on very few studies on traditional vaccines, generally counterbalanced by a higher number of reports, which did not show any significant negative interference in the immune response to vaccines, thus providing an explanation of the divergent recommendations.…”

“…All the authorized COVID-19 vaccines can stimulate specific cellular immunity (Table 4) Moreover, immunosuppressive treatment has even been associated in some studies, with a protective effect on the cytokine release syndrome [112] observed in some cases of SARS-CoV-2 infection. All these considerations may explain the different evaluations by the different Scientific Societies/Colleges, including EULAR [104], ACR [105,106], and the Korean College of Rheumatology [113], which has an intermediate position compared to the other two. All agree on the inhibitory effect of CCS and anti-CD20 mAbs [114], either isolated or in combination.…”

“…Although in the pre-approval studies details on the possible presence of patients with AIAIDs in the study population have not been provided, recent studies have reported substantial safety and immunogenicity of these vaccines in patients with AIAIDs [48][49][50]92,[106][107][108]. Even in PIDs, two preliminary studies [98,99] have shown the substantial safety and immunogenicity of the mRNA vaccines.…”

“…The Task Force does not consider it appropriate to interrupt/discontinue immunosuppressive therapy, excepting for high dosage CCS (≥10 mg of prednisone-equivalent [104]) and anti-CD20 mAbs, such as rituximab [103][104][105] (Table 6). Moreover, in the case of MTX [105,106], abatacept [105,106], JKI [105,106], and mycophenolate [106], the immunology specialist will evaluate the possible discontinuation based on the patients' clinical characteristics. Regarding PIDs, the risk of non-response should be evaluated, especially in severe combined and humoral immunodeficiencies.…”

Evaluation of antibody response to BNT162b2 mRNA COVID-19 vaccine in patients affected by immune-mediated inflammatory diseases up to 5 months after vaccination

“…Moreover, in these patients the infection risk may be even higher for both the altered regulation of the immune system itself and for the immunosuppressive effects of medications [8]. Indeed, vaccinations in this population are complicated by disease-modifying immunosuppressive agents or antirheumatic drugs (either conventional, targeted synthetic or biologicals), which modulate or suppress key targets of the immune system and potentially decrease the immunogenicity and e cacy of the vaccines [9]. However, there is scant available data on real-world cohorts of vaccinated subjects and very limited data about response to COVID-19 mRNA vaccines in patients affected by IMID.…”