Abstract

ObjectiveTo provide guidelines on the coronavirus disease 2019 (COVID-19) vaccination in patients with immune-mediated rheumatic diseases (IMRD) to rheumatologists considering specific scenarios of the daily practice based on the shared-making decision (SMD) process.MethodsA task force was constituted by 24 rheumatologists (panel members), with clinical and research expertise in immunizations and infectious diseases in immunocompromised patients, endorsed by the Brazilian Society of Rheumatology (BSR), to develop guidelines for COVID-19 vaccination in patients with IMRD. A consensus was built through the Delphi method and involved four rounds of anonymous voting, where five options were used to determine the level of agreement (LOA), based on the Likert Scale: (1) strongly disagree; (2) disagree, (3) neither agree nor disagree (neutral); (4) agree; and (5) strongly agree. Nineteen questions were addressed and discussed via teleconference to formulate the answers. In order to identify the relevant data on COVID-19 vaccines, a search with standardized descriptors and synonyms was performed on September 10th, 2021, of the MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and LILACS to identify studies of interest. We used the Newcastle–Ottawa Scale to assess the quality of nonrandomized studies.ResultsAll the nineteen questions-answers (Q&A) were approved by the BSR Task Force with more than 80% of panelists voting options 4—agree—and 5—strongly agree—, and a consensus was reached. These Guidelines were focused in SMD on the most appropriate timing for IMRD patients to get vaccinated to reach the adequate covid-19 vaccination response.ConclusionThese guidelines were developed by a BSR Task Force with a high LOA among panelists, based on the literature review of published studies and expert opinion for COVID-19 vaccination in IMRD patients. Noteworthy, in the pandemic period, up to the time of the review and the consensus process for this document, high-quality evidence was scarce. Thus, it is not a substitute for clinical judgment.

Highlights

  • The pandemic of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), whose first case was described in Wuhan, China, in December 2019 [1], is the most significant health crisis being faced by humanity currently, and this has motivated efforts by the scientific community to seek ways to combat the transmission of this new virus

  • All the nineteen questions-answers (Q&A) were approved by the Brazilian Society of Rheumatology (BSR) Task Force with more than 80% of panelists voting options 4—agree—and 5—strongly agree, and a consensus was reached. These Guidelines were focused in shared-making decision (SMD) on the most appropriate timing for immunemediated rheumatic diseases (IMRD) patients to get vaccinated to reach the adequate covid-19 vaccination response

  • These guidelines were developed by a BSR Task Force with a high level of agreement (LOA) among panelists, based on the literature review of published studies and expert opinion for COVID-19 vaccination in IMRD patients

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Summary

Introduction

The pandemic of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), whose first case was described in Wuhan, China, in December 2019 [1], is the most significant health crisis being faced by humanity currently, and this has motivated efforts by the scientific community to seek ways to combat the transmission of this new virus. Patients with IMRD may have a reduced immune response due to the underlying disease or immunosuppressive treatment. They have a higher risk of infections, the leading causes of hospitalizations and deaths in this group of patients [7]. For this reason, the discussion on immunization against SARS-CoV-2 has become an urgent and relevant issue [8]. It is essential to emphasize that cellular and humoral immune responses are essential, and isolated response measures can lead to a mistaken idea of ineffectiveness [7]

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