Background: This study aimed to evaluate flares in systemic lupus erythematosus (SLE) patients over a period of six months after COVID-19. Methods: A multicenter, observational, and prospective cohort study was performed. SLE adult patients with COVID-19 (case group) were compared to SLE patients without COVID-19 (control group). Assessments were performed at baseline (V0), immediately after COVID-19 (V1), and three and six months after infection (V2 and V3). Disease activity was evaluated using the patient global assessment (PGA) and the modified SLE Disease Activity Index 2000 (mSLEDAI-2K). Flare was defined as an increase in the mSLEDAI-2K score of greater than three, and persistent disease activity was defined as mSLEDAI-2K score greater than three over two consecutive visits. Results: 715 patients were included, 363 in the case group and 352 in the control group. The case group had a higher mean age (SD) compared with the control group [41 years (12.38) versus 38.8 years (12.07), p=0.017]. The control group showed a significant reduction in PGA [0.24 (95% CI: -0.39 to -0.09), p=0.001] and SLEDAI-2K [0.85 (95% CI: 0.76 to 0.96) p=0.010] over the visits while in the case group the scores remained stable. The case group presented more frequent flares or persistent disease activity [74 (18.5%) versus 33 (10.5%), p=0.001]. COVID-19 at any time in the study was linked to a higher chance of a flare or persistent disease activity [OR=1.70 (95% CI: 1.06 to 2.74), p=0.029]. Conclusions: COVID-19 was associated with worse outcomes in SLE patients.

Patients with immune-mediated rheumatic diseases (IMRD) are at increased risk for infections due to both disease-related immune dysregulation and immunosuppressive therapy. Despite the benefits of vaccination, immunization rates in this population remain suboptimal, often due to concerns about safety, efficacy, and their potential for inducing disease flare. Regional-specific guidelines are necessary to address the particular epidemiological issues and aspects of the healthcare systems, especially in countries like Brazil. To provide updated, evidence-based, and nationally relevant recommendations on vaccination in adult patients with IMRD in Brazil, focusing on immunogenicity, safety and disease activity outcomes. A multidisciplinary task force from the Brazilian Society of Rheumatology conducted a systematic review and meta-analysis of studies addressing eleven clinical questions related to vaccine safety and efficacy in IMRD. Studies were selected using predefined PICO criteria. Risk of bias was assessed using JBI tools, and the certainty of evidence was evaluated with the GRADE approach. Statements were developed and submitted to a Delphi-based voting process; consensus was achieved if ≥80

In response to a letter addressing the Brazilian guidelines for tuberculosis infection (TBI) screening in immune-mediated inflammatory diseases (IMID), we clarify that the recommendations reflect a structured, evidence-based consensus developed by a multidisciplinary panel, in accordance with internationally accepted standards. We reaffirm the rationale for annual TBI retesting during the first three years of immunosuppressive therapy, particularly with TNF inhibitors, and the outweighed risk of tuberculosis preventive treatment (TPT), given the benefits. These recommendations are aligned with national and international public health policies and underscore the need for flexibility in clinical judgment. Nonetheless, they are conditional, reflecting the limited robustness of the available evidence. Continued dialogue is essential to ensure the safety and protection of IMID patients in high-burden settings like Brazil.

Background The risk of tuberculosis infection (TBI) and its progression to tuberculosis disease (TBD) among persons with immune-mediated inflammatory diseases (IMID) results from a complex interplay of patient and disease characteristics, immunosuppression level, and the epidemiological context. Brazilian recommendations are unclear about TBI screening and its preventive treatment (TPT) in persons with IMID. Objective To provide a comprehensive and evidence-based guideline for managing TBI in persons with IMID in Brazil. Methods This task force was constituded by 42 specialists with interest in IMID and TBD. A core leadership team (CLT) drafted fourteen clinical questions on the risk of tuberculosis and indications of TPT among persons with IMID who started, or are about to start immunosuppressive drugs. The CLT supervised the systematic reviews and formulated the recommendations. The experts voted using the Delphi Method. Results Nine recommendations were established. More than 80% of panelists voted “agree” and “strongly agree” with all statements. In brief, all persons with IMID starting or about to start immunosuppressive treatment should undergo tuberculin skin testing (TST) or interferon-gamma release assays (IGRAs), a chest imaging test and investigation of contact with active pulmonary or laryngeal TBD. TPT is mandatory for those with any positive result after excluding TBD. Exceptions include individuals with a history of TBD or a past positive TBI infection test. IGRA is preferred only in persons BCG-vaccinated in the past 2 years. Those with inconclusive IGRA results can have the test repeated once, and TPT should be offered if it remains indeterminate. TST or IGRA should be repeated yearly, for three years, when the previous test was negative, when starting or changing to a different class of immunosuppressive drug. Overall, the included studies had a low quality of evidence and high risk of bias. Conclusions These guidelines are meant to improve the management of TBI in IMID. Health professionals must consider the epidemiological risk, host features, the social scenario, the characteristics of the disease, the access to health resources, and the development of an individualized plan for every patient.

Abstract Background Rheumatic diseases are associated with an increase in overall risks of tuberculosis (TB). The aim of this study was to evaluate the frequency of TB and the frequency of latent TB infection (LTBI), in clinical practice, for juvenile idiopathic arthritis (JIA) patients from high and low risk of TB incidence endemic countries. Methods This is an international, multicenter, cross-sectional, observational study of data collection from Brazil and Registry of Portugal at REUMA.PT. The inclusion criteria were patients with Juvenile Idiopathic Arthritis (JIA) with age ≤ 18 years who underwent screening for Mycobacterium tuberculosis infection [tuberculin skin test (TST) and/or interferon gamma release assay (IGRA)]. Chest X-rays and history of exposure to TB were also assessed. Results 292 JIA patients were included; mean age 14.3 years, mean disease duration 7.5 years, 194 patients (66.4%) performed only TST, 14 (4.8%) only IGRA and 84 (28.8%) both. The frequency of LTBI (10.6%) and TB was similar between the two countries. The reasons for TB screening were different; in Brazil it was performed more often at JIA onset while in Portugal it was performed when starting Disease Modified Anti-Rheumatic Drugs (DMARD) treatment (p < 0.001). Isoniazid therapy was prescribed in 40 (13.7%) patients (31 with LTBI and 9 with epidemiologic risks and/or due to contact with sick people). Only three patients (1%) developed active TB. Conclusion We found nearly 10% of patients with LTBI, a small percentage of patients with treatment due to epidemiologic risks and only 1% with active TB. Distinct reasons and screening methods for LTBI were observed between the two countries.

Background: Although clinical risk factors for poor COVID-19 outcomes have been identified in people with rheumatic disease, associations between environmental and societal factors and poor outcomes remain unknown. We investigated whether country-level environmental and societal factors were associated with COVID-19-related death in people with rheumatic disease.Methods: Individual-level data on adults with rheumatic disease and COVID-19 were derived from the COVID-19 Global Rheumatology Alliance Registry from March 2020 to August 2021. Country-level covariates potentially associated with death were obtained from publicly available sources. Multivariable logistic regression was used to evaluate independent associations between regional characteristics and death, after controlling for known individual-level risk factors. A series of nested mixed-effects regression models with country as random effects were used to determine whether the regional covariates identified sufficiently explained country-level variations in death.Findings: We included 14,044 patients, from 23 countries. Mean (SD) age was 54.4 (15.6) years and 10,178 (72.5%) were female. Factors positively associated with death included air pollution (odds ratio: 1.10 per 10-micrograms increase in fine particulate matter per cubic meter, 95% CI: 1.01-1.17), the share of population aged 65 or older (1.19 per 1% increase, 1.10-1.30) and population mobility (1.03 per 1% increase in number of visits to grocery and pharmacy stores, 1.02-1.05). Number of hospital beds (0.94 per unit increase per 1,000 population, 0.88-1.00), human development index (0.65 per 0.1-unit increase, 0.44-0.96), and government response stringency (0.83 per 10-unit increase in containment index, 0.74-0.93) were associated with fewer deaths. These factors sufficiently explained country-level variations in death (Intraclass correlation coefficient = 1.2%, 95% CI: 0.1-9.5%, p = 0.14) .Interpretation: Our findings highlight the importance of environmental and societal factors as potential explanations of the disparate impact of COVID-19 on people with rheumatic disease, globally.Funding Information: MAG is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (grant numbers K01 AR070585 and K24 AR074534 [JY]). KDW is supported by the Department of Veterans Affairs and the Rheumatology Research Foundation Scientist Development award. JAS is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (grant numbers K23 AR069688, R03 AR075886, L30 AR066953, P30 AR070253, and P30 AR072577), the Rheumatology Research Foundation (K Supplement Award and R Bridge Award), the Brigham Research Institute, and the R. Bruce and Joan M. Mickey Research Scholar Fund. NJP is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (T32-AR-007258). ADG is supported by grants from the Centers for Disease Control and Prevention and the Rheumatology Research Foundation. RH was supported by the Justus-Liebig University Giessen Clinician Scientist Program in Biomedical Research (JLU-CAREER) to work on this registry. JY is supported by grants from the National Institutes of Health (K24 AR074534 and P30 AR070155).Declaration of Interests: MID reports research support from Pfizer for unrelated work. AS reports grants from a consortium of 13 companies (among them AbbVie, BMS, Celltrion, Fresenius Kabi, Lilly, Mylan, Hexal, MSD, Pfizer, Roche, Samsung, Sanofi-Aventis, and UCB) supporting the German RABBIT register and personal fees from lectures for AbbVie, MSD, Roche, BMS, Pfizer, outside the submitted work. EFM reports that LPCDR received support for specific activities: grants from Abbvie, Novartis, Janssen-Cilag, Lilly Portugal, Sanofi, Grünenthal S.A., MSD, Celgene, Medac, Pharmakern, GAfPA; grants and non-financial support from Pfizer; non-financial support from Grünenthal GmbH, outside the submitted work. KLH reports she has received speaker’s fees from Abbvie and grant income from BMS, UCB, and Pfizer, all unrelated to this study. KLH is also supported by the NIHR Manchester Biomedical Research Centre. LG reports research grants: Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz, Sanofi; consulting fees: AbbVie, Amgen, BMS, Biogen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, all unrelated to this study. LC has not received fees or personal grants from any laboratory, but her institute works by contract for laboratories among other institutions, such as Abbvie Spain, Eisai, Gebro Pharma, Merck Sharp & Dohme España, S.A., Novartis Farmaceutica, Pfizer, Roche Farma, Sanofi, Aventis, Astellas Pharma, Actelion Pharmaceuticals España, Grünenthal GmbH, and UCB Pharma. JAS has performed consultancy for AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, and Optum unrelated to this work. LW has received consulting/speaking fees from Aurinia Pharma outside the scope of the submitted work. MFUG reports grant/research support from: Jannsen, Pfizer, not related to this article. The Swedish Rheumatology Register, SRQ, with LL as register holder, has agreements with Abbvie, Amgen, Eli Lilly, Gilead, Novartis, Pfizer, Sanofi, Sobi and UCB for register data analyses unrelated to this work. CR has received consulting/speaker’s fees from Abbvie, Amgen, AstraZeneca, BMS, Biogen, Eli Lilly, Glenmark, GSK, MSD, Mylan and Pfizer, and grants from Biogen, Lilly and Nordic Pharma, all unrelated to this manuscript. MJS has received speaker fees from Abbvie, AstraZeneca, Novartis, and Pfizer (all < 10 000 euros). AR has received speaker fees from Janssen, Pfizer, and Novartis. GPE reports no competing interests related to this work; outside of this work, he reports personal consulting and/or speaking fees from Pfizer, GSK, Janssen, Sandoz and Sanofi (all < $10,000). PCR reports personal consulting and/or speaking fees from Abbvie, Eli Lilly, Janssen, Novartis, Pfizer and UCB and travel assistance from Roche (all < $10,000). PMM has received consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche and UCB, all unrelated to this study (all < $10,000). PMM is supported by the National Institute for Health Research (NIHR) University College London Hospitals (UCLH) Biomedical Research Centre (BRC). ES is a Board Member of the Canadian Arthritis Patient Alliance, a patient run, volunteer-based organization whose activities are largely supported by independent grants from pharmaceutical companies. JWL has received research funding from Pfizer outside the submitted work. JSH is supported by grants from the Rheumatology Research Foundation and has salary support from the Childhood Arthritis and Rheumatology Research Alliance. He has performed consulting for Novartis, Sobi, Biogen, all unrelated to this work (< $10,000). SB reports non-branded consulting fees for AbbVie, Horizon, and Novartis(all < $10,000), and is employed by Pfizer. ZSW reports grant support from Bristol-Myers Squibb and Principia/Sanofi and performed consultancy for Viela Bio and MedPace, outside the submitted work. His work is supported by grants from the National Institutes of Health. Outside of this work, JY has performed consulting for Eli Lilly, Pfizer, Aurinia and AstraZeneca. ZI, MAG, GS, LJ, PK, SR, CJ, TT, KS, KDW, SLT, LKF, MS, SAE, TYTH, NJP, EG, ADG, MOVA, CAS, GC, EH, PC, TT, MB, HSK, RH, UML, RT, REN, CNP, RMX, CDLM, GCSP, and MGM report no disclosures relevant to this study.Ethics Approval Statement: The COVID-19 Global Rheumatology Alliance (GRA) provider registry contains only limited data; no personal identifiers, with the exception of COVID-19 diagnosis dates, are included. The GRA registry was determined to be nonhuman subjects research by the United Kingdom Health Research Authority, the University of Manchester (United Kingdom), and the University of California, San Francisco, and ethics committee approval or informed consent was therefore not required.

Objectives To evaluate the disease activity before and after COVID-19 and risk factors associated with outcomes, including hospitalization, intensive care unit (ICU) admission, mechanical ventilation (MV) and death in patients with spondylarthritis (SpA). Methods ReumaCoV Brazil is a multicenter prospective cohort of immune-mediated rheumatic diseases (IMRD) patients with COVID-19 (case group), compared to a control group of IMRD patients without COVID-19. SpA patients enrolled were grouped as axial SpA (axSpA), psoriatic arthritis (PsA) and enteropathic arthritis, according to usual classification criteria. Results 353 SpA patients were included, of whom 229 (64.9%) were axSpA, 118 (33.4%) PsA and 6 enteropathic arthritis (1.7%). No significant difference was observed in disease activity before the study inclusion comparing cases and controls, as well no worsening of disease activity after COVID-19. The risk factors associated with hospitalization were age over 60 years (OR = 3.71; 95% CI 1.62–8.47, p = 0.001); one or more comorbidities (OR = 2.28; 95% CI 1.02–5.08, p = 0.001) and leflunomide treatment (OR = 4.46; 95% CI 1.33–24.9, p = 0.008). Not having comorbidities (OR = 0.11; 95% CI 0.02–0.50, p = 0.001) played a protective role for hospitalization. In multivariate analysis, leflunomide treatment (OR = 8.69; CI = 95% 1.41–53.64; p = 0.023) was associated with hospitalization; teleconsultation (OR = 0.14; CI = 95% 0.03–0.71; p = 0.01) and no comorbidities (OR = 0.14; CI = 95% 0.02–0.76; p = 0.02) remained at final model as protective factor. Conclusions Our results showed no association between pre-COVID disease activity or that SARS-CoV-2 infection could trigger disease activity in patients with SpA. Teleconsultation and no comorbidities were associated with a lower hospitalization risk. Leflunomide remained significantly associated with higher risk of hospitalization after multiple adjustments.

Objective To 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. Methods A 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. Results All 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. Conclusion These 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.

Background:Differences in the distribution of individual-level clinical risk factors across regions do not fully explain the observed global disparities in COVID-19 outcomes. We aimed to investigate the associations between environmental and societal factors and country-level variations in mortality attributed to COVID-19 among people with rheumatic disease globally. Methods:In this observational study, we derived individual-level data on adults (aged 18-99 years) with rheumatic disease and a confirmed status of their highest COVID-19 severity level from the COVID-19 Global Rheumatology Alliance (GRA) registry, collected between March 12, 2020, and Aug 27, 2021. Environmental and societal factors were obtained from publicly available sources. The primary endpoint was mortality attributed to COVID-19. We used a multivariable logistic regression to evaluate independent associations between environmental and societal factors and death, after controlling for individual-level risk factors. We used a series of nested mixed-effects models to establish whether environmental and societal factors sufficiently explained country-level variations in death. Findings:14 044 patients from 23 countries were included in the analyses. 10 178 (72·5%) individuals were female and 3866 (27·5%) were male, with a mean age of 54·4 years (SD 15·6). Air pollution (odds ratio 1·10 per 10 μg/m3 [95% CI 1·01-1·17]; p=0·0105), proportion of the population aged 65 years or older (1·19 per 1% increase [1·10-1·30]; p<0·0001), and population mobility (1·03 per 1% increase in number of visits to grocery and pharmacy stores [1·02-1·05]; p<0·0001 and 1·02 per 1% increase in number of visits to workplaces [1·00-1·03]; p=0·032) were independently associated with higher odds of mortality. Number of hospital beds (0·94 per 1-unit increase per 1000 people [0·88-1·00]; p=0·046), human development index (0·65 per 0·1-unit increase [0·44-0·96]; p=0·032), government response stringency (0·83 per 10-unit increase in containment index [0·74-0·93]; p=0·0018), as well as follow-up time (0·78 per month [0·69-0·88]; p<0·0001) were independently associated with lower odds of mortality. These factors sufficiently explained country-level variations in death attributable to COVID-19 (intraclass correlation coefficient 1·2% [0·1-9·5]; p=0·14). Interpretation:Our findings highlight the importance of environmental and societal factors as potential explanations of the observed regional disparities in COVID-19 outcomes among people with rheumatic disease and lay foundation for a new research agenda to address these disparities. Funding:American College of Rheumatology and European Alliance of Associations for Rheumatology.

Objectives: The engagement of undergraduate medical students (MS) in clinical research may lead to improvement in scientific method critical analysis, better performance as young physicians, awareness of innovation, and the development of leadership skills and teamwork perspectives (1). This study evaluated changings in daily routine and the awareness of patients' realities reported by MS participating on a research project involving rheumatic patients in Brazil during the COVID-19 pandemic. Methods: A secondary analysis of a web-based cross-sectional survey (2) including MS participating of Mario Pinotti II study (MPII) (3) was performed. Demographic characterization and the description of the MS impressions of the impact of participating of MPII are reported. Results: A total of 228 (58%) MS involved in MPII responded to the survey: 151 (66%) were women with (Mean(SD)) 22.8 (2.8) years of age, most were studying in public (N = 135 (59%)) medical schools, from 10 Brazilian states. Figures 1 and 2 summarizeMS' reports on the impact of participating of MPII on their daily routine and increased awareness of patient's realities. Conclusion: MS participating on the MPII study reported a better understanding of rheumatic patients' fears and uncertainties during the COVID-19 pandemic, including hydroxychloroquine shortage, lack of medical appointments and an unmet need related to more adequate information addressed to the rheumatic diseases. Furthermore, the close interaction among rheumatic patients, faculty, rheumatologists, and otherMShave provided a significant improvement in their feelings of usefulness during the pandemic and could contribute to their future professional activities.

Objective To describe the laboratory parameters and biomarkers of the cytokine storm syndrome associated with severe and fatal COVID-19 cases. Methods A search with standardized descriptors and synonyms was performed on November 28th, 2020 of the MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, LILACS, and IBECS to identify studies of interest. Grey literature searches and snowballing techniques were additionally utilized to identify yet-unpublished works and related citations. Two review authors independently screened the retrieved titles and abstracts, selected eligible studies for inclusion, extracted data from the included studies, and then assessed the risk of bias using the Newcastle-Ottawa Scale. Eligible studies were those including laboratory parameters—including serum interleukin-6 levels—from mild, moderate, or severe COVID-19 cases. Laboratory parameters, such as interleukin-6, ferritin, hematology, C-Reactive Protein, procalcitonin, lactate dehydrogenase, aspartate aminotransferase, creatinine, and D-dimer, were extracted from the studies. Meta-analyses were conducted using the laboratory data to estimate mean differences with associated 95% confidence intervals. Data synthesis The database search yielded 9,620 records; 40 studies (containing a total of 9,542 patients) were included in the final analysis. Twenty-one studies (n = 4,313) assessed laboratory data related to severe COVID-19 cases, eighteen studies (n = 4,681) assessed predictors for fatal COVID-19 cases and one study (n = 548) assessed laboratory biomarkers related to severe and fatal COVID-19 cases. Lymphopenia, thrombocytopenia, and elevated levels of interleukin-6, ferritin, D-dimer, aspartate aminotransferase, C-Reactive-Protein, procalcitonin, creatinine, neutrophils and leucocytes were associated with severe and fatal COVID-19 cases. Conclusions This review points to interleukin-6, ferritin, leukocytes, neutrophils, lymphocytes, platelets, C-Reactive Protein, procalcitonin, lactate dehydrogenase, aspartate aminotransferase, creatinine, and D-dimer as important biomarkers of cytokine storm syndrome. Elevated levels of interleukin-6 and hyperferritinemia should be considered as red flags of systemic inflammation and poor prognosis in COVID-19.

Objectives: To identify potential predictors of COVID-19 vaccine hesitancy (C19-VH) in adults with immune-mediated inflammatory diseases (IMID). Methods: A total of 1000 IMID patients were enrolled in this web-based cross-sectional study. A standardised and self-administered survey was designed by members of the Brazilian Society of Rheumatology Steering Committee for Infectious and Endemic diseases and distributed to IMID patients spread across Brazil. Results: Of the 908 (90.8%) respondents eligible for analysis, 744 (81.9%) were willing to get vaccinated against COVID-19. In our multivariable logistic regression model, concurrent malignancy, fibromyalgia, hydroxychloroquine use, and recent corticosteroid pulse therapy were independently associated with higher odds of C19-VH. The short duration of COVID-19 vaccine clinical trials was the main reason for C19-VH. Conclusion: We identified novel characteristics potentially associated with C19-VH among adults with IMID. Greater awareness on the safety and efficacy of COVID-19 vaccines is needed for both IMID patients and attending physicians. (c) 2021 Elsevier Ltd. All rights reserved.

Background COVID-19, caused by the virus SARS-CoV-2, has brought extensive challenges to the scientific community in recent months. Several studies have been undertaken in an attempt to minimize the impact of the disease worldwide. Although new knowledge has been quickly disseminated, including viral mechanisms, pathophysiology, and clinical findings, there is a lack of information on the effective pharmacological management of this disease. In vitro studies have shown some benefits related to the use of antimalarials (chloroquine and hydroxychloroquine) for inhibiting SARS-CoV-2. However, the data from open clinical trials on COVID-19 patients are controversial. Objective We present the protocol for a research project that compares the potential protective effect of antimalarials in preventing moderate-to-severe forms of COVID-19 in two groups: (1) patients treated chronically with antimalarials for rheumatic diseases and (2) other members of the patients’ household who have not been diagnosed with rheumatic diseases and are not taking antimalarials. Methods This is a 24-week, prospective, observational cohort study comprising patients from public and private health services across Brazil, who chronically use antimalarials for the treatment of immune-mediated rheumatic diseases, osteoarthritis, or chikungunya-related arthropathy. A total of six sequential phone interviews were scheduled during the COVID-19 outbreak in five different regions of Brazil. Information regarding social, epidemiological, and demographic data, as well as details about rheumatic diseases, antimalarials, comorbidities, and concomitant medication, is being recorded using a specific online form in the REDCap database. Symptoms suggestive of COVID-19, including fever, cough, dyspnea, anosmia, and dysgeusia, are being self-reported and collected via phone interviews. Our main outcomes are hospitalization, need of intensive care unit, and death. Results Recruitment began at the end of March 2020, and the inclusion was done during an 8-week period (from March 29 to May 17) with a total of 10,443 individuals enrolled at baseline, 5166 of whom have rheumatic diseases, from 23 tertiary rheumatology centers across 97 Brazilian cities. Data analysis is scheduled to begin after all inclusion data have been collected. Conclusions This study, which includes a large sample of chronic antimalarial users, will allow us to explore whether SARS-CoV-2 infection may be associated with immune-mediated rheumatic diseases and long-term antimalarial usage. Trial Registration Brazilian Registry of Clinical Trials RBR–9KTWX6; http://www.ensaiosclinicos.gov.br/rg/RBR-9ktwx6/ International Registered Report Identifier (IRRID) DERR1-10.2196/23532

Objective This study aimed to assess the safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccination in childhood-onset systemic lupus erythematosus (cSLE) patients. Methods Volunteer cSLE patients aged 9–20 years and healthy controls (HC) were enrolled to receive a two- or three-dose qHPV vaccination schedule from March 2014 to March 2016. Study visits were performed before the first dose, one month after the second and third doses and one year after the first dose. In each study visit, disease activity and adverse events following vaccination were analyzed, and a serum sample was collected for testing antibody concentrations. Participant recruitment was conducted in 15 Brazilian paediatric rheumatology units. Of the 256 cSLE patients included, 210 completed the two- or three-dose schedules; 15 had previously received one dose, and 18 had received two doses of the vaccine. The analysis was based on intention-to-treat so that participants who did not complete the entire study protocol were also included. Results No severe adverse events were related to the vaccination. Disease activity was generally low and remained stable or even improved. The HC presented 100% seropositivity to HPV16 and HPV18, whereas the two- and three-dose cSLE groups presented 93% and 83% versus 97% and 91%, respectively. One year after the first dose, seropositivity of the three-dose cSLE group was 91% to HPV16 and 84% to HPV18. Conclusions HPV vaccination in cSLE patients is safe and immunogenic. Since the seropositivity to HPV16 and HPV18 was higher for the three-dose schedule group, this regimen should be recommended for cSLE patients.

Acquired immunodeficiency syndrome and lupus erythematosus are multisystem diseases that can affect several organs and systems at different stages of disease evolution.Both diseases share common clinical manifestations, which may lead to diagnostic difficulties, especially at the onset of the disease.Another additional challenge is when there is an association of the two pathologies.The objective of this brief review is to describe the clinical manifestations of the diseases and to make considerations regarding the moment of onset of symptoms.Knowledge of these common manifestations and their peculiarities may alert clinicians to possible diagnoses and avoid errors in the evaluation and conduction of these patients.

Background: Arthritis and arthralgia are reported as adverse events following immunization with various vaccines. Objective: To better understand current knowledge of arthritis and arthralgia as an adverse event following immunization. Methods: A systematic literature review of Pubmed, Embase, and Cochrane Library was conducted. Data extraction was performed by two independent reviewers. No restrictions on dates were imposed and all types of vaccine studies with primary data were reviewed. Results: Of 343 included studies, there were 206 clinical trials, 90 observational studies, and 47 case reports. Influenza was the most commonly studied vaccine (n = 91, 24.4%). Of the 155 (45.2%) studies addressing causality assessment, 84 studies (54.2%) revealed the assessment method. Only seven clinical trials and 12 observational studies reported a measure of association. Four of these studies examined worsening of arthritic conditions in patients with pre-existing disease. Rigorous assessment of causality was not performed in most studies and many observational studies were prone to bias. Conclusions: The current evidence linking vaccination to incident arthritis or worsening of arthritic conditions is too heterogeneous and incomplete to infer a causal association. Recommendations for future studies include use of consistent, standardized case definitions and causality assessments, better control of confounding and minimization of bias, and inclusion of measures of associations. (C) 2018 Published by Elsevier Ltd.

Juvenile idiopathic arthritis (JIA) is the most prevalent chronic rheumatic disease in children and young people (CYP) and a major cause of pain and disability. The vast majority of the world’s children and their families live in less resourced countries (LRCs) and face significant socioeconomic and healthcare challenges. Current recommendations for standards of care and treatment for children with JIA do not consider children living in less resourced countries. In order to develop appropriate recommendations for the care of CYP with JIA in less resourced countries a meeting of experienced pediatric rheumatologists from less resourced countries was convened with additional input from a steering group of international pediatric rheumatologists with experience in developing recommendations and standards of care for JIA. Following a needs assessment survey of healthcare workers caring for CYP with JIA in LRC, a literature review was carried out and management recommendations formulated using Delphi technique and a final consensus conference. Responses from the needs assessment were received from 121/483 (25%) practitioners from 25/49 (51%) less resourced countries. From these responses, the initial 84 recommendations were refined and expanded through a series of 3 online Delphi rounds. A final list of 90 recommendations was proposed for evaluation. Evidence for each statement was reviewed, graded, and presented to the consensus group. The degree of consensus, level of agreement, and level of evidence for these recommendations are reported. Recommendations arrived at by consensus for CYP with JIA in less resourced countries cover 5 themes: (1) diagnosis, (2) referral and monitoring, (3) education and training, (4) advocacy and networks, and (5) research. Thirty-five statements were drafted. All but one statement achieved 100% consensus. The body of published evidence was small and the quality of evidence available for critical appraisal was low. Our recommendations offer novel insights and present consensus-based strategies for the management of JIA in less resourced countries. The emphasis on communicable and endemic diseases influencing the diagnosis and treatment of JIA serves as a valuable addition to existing JIA guidelines. With increasing globalization, these recommendations as a whole provide educational and clinical utility for clinicians worldwide. The low evidence base for our recommendations reflects a shortage of research specific to less resourced countries and serves as an impetus for further inquiry towards optimizing care for children with JIA around the world.