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Objectives: Patients with Systemic Lupus Erythematosus (SLE) are predisposed to serious infections due to immunocompromise, comorbidities, immunomodulatory and/or immunosuppressive therapy, as well as the lack of these medications faced by patients dependent on the Sistema Unico de Saude (SUS) during the COVID-19 pandemic. Studies revealed a low risk of worsening disease activity after vaccination against SARS-CoV-2 and safety in the continuity of immunomodulatory therapy during the vaccination stages. Thus, immunization against COVID-19 is an important pillar in reducingmorbidity and mortality related to infectious conditions and SLE. This study had the objective to understand the disease activity in SLE patients after vaccination against COVID-19. Method(s): This is an observational, longitudinal, ambidirectional study with follow-up of subgroups of patients with immune-mediated rheumatic diseases immunized with vaccines made available by the Programa Nacional de Imunizacao (Butantan Institute, Pfizer/BioNTech, BioManguinhos/Fiocruz and Janssen). Data from the SLE disease activity index 2000 (SLEDAI-2 K) and sociodemographic data were collected and stored via an online platform, with a comparison of the index before and after each dose. This study was approved by the local Research Ethics Committee, and it is associated to the SAFER Project from Brazilian Society of Rheumatology. Result(s): A total of 223 patients were included, of which 83% were female and 39% had SLE, 36.7 +/- 11.76 years old. Regarding the disease activity, at inclusion the mean PGA score(SD) was 2,61 +/- 2,77. After the 1st dose it was 1.38 +/- 2.17, after the 2nd dose it was 2,35 +/- 2,99, after the 3rd dose it was 2,19 +/- 2,58 and after the 4th dose 1.18 +/- 1.88. The mean SLEDAI-2 K score at inclusion was 7,27 +/- 9,70, after the 1st dose it was 2,75 +/- 5,29, after the 2nd dose it was 4,73 +/- 6,40, after the 3rd dose 3,33 +/- 5,51 and after the 4th dose 2.12 +/- 4.27. 6% of the patients referred worsening disease activity after the 1st dose, 14,3%after the 2nd dose, and no patient reportedworsening of disease activity after the 3rd and 4th doses. Conclusion(s): Vaccination did not contribute toworsening disease activity of the SLE patientss studied, according to the indices used to assess disease activity.
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Objectives: Immunization against SARS-CoV-2 is an effective strategy to reduce morbidity and mortality in the face of the COVID-19 pandemic. People with Immune-mediated Rheumatic Diseases (IMRD) also benefited from this campaign. However, there is a limited amount of data on the outcome of vaccination in these patients, in terms of those who were infected by the virus. This study had the objective to evaluate the rate of COVID-19 cases in patients with IMRD after vaccination against SARS-CoV-2. Method(s): Observational, longitudinal and ambidirectional study with follow-up of subgroups of patients with IMRD immunized with vaccines made available by the National Immunization Plan (inactivated adsorbed vaccine registered by the Instituto Butantan (IB), recombinant vaccines registered by Bio Manguinhos/ Fiocruz and by Janssen, and Pfizer/BioNTech). Sociodemographic data and questionnaires on flu syndrome, laboratory confirmation of infection and need for hospitalization and outcomes were collected and stored via an online platform. This study is associated to the SAFER Project from the Brazilian Society of Rheumatology and it was approved by the local Research Ethics Committee. Result(s): A total of 223 patients aged over 18 years, mean age 42.79 +/- 15.18 years, were included. All were within the inclusion/exclusion criteria, with 83% being female. The main IMRD included were systemic lupus erythematosus (39%) and rheumatoid arthritis (33.6%). After the 1st dose, 1.45% of patients had COVID-19, 50% sought health services (emergency care), without the need for hospitalization and after the 2nd dose, 1.5% had the disease, of which none sought health services, required hospitalization or had a negative outcome. After the 3rd dose,: 2.9%were infected with SARS-CoV-2 one month later, 15.6% two to three months later and 5.5% four to six months later, all with laboratory confirmation;only 4% presenting any serious complication;there were no deaths. After the 4th dose, 9.1%of patients had COVID-19, of which 40%were hospitalized, without the need for assisted ventilation;half of these patients had a serious complication, but there no deaths. Conclusion(s): In this study, we observed the effectiveness of the vaccine in preventing severe cases of COVID-19 and complications of SARS-CoV-2 infection.
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Objectives: Chronic Inflammatory Immune-mediated Diseases (CIMD) can cause pain and severe discomfort to the patient, leading to significant reductions in his/her quality of life. Vaccination against COVID-19 has proven to be an efficient method in preventing cases and serious repercussions. However, there is insufficient evidence on the safety of these vaccines in the CIMD population. Objective(s): To assess disease activity in adolescent patients with CIMD after vaccination against SARS-CoV-2. Method(s): Observational, longitudinal, ambidirectional study with follow-up of groups of adolescent patients with CIMDwho received the vaccine provided by the National Immunization Program -Pfizer/BioNTech. Sociodemographic and clinical disease activity data were collected before and after each vaccine dose. Data were stored through an online platform (REDCap). This study is associated to the SAFER Project from the Brazilian Society of Rheumatology and was approved by the local Research Ethics Committee. Result(s): Nineteen adolescents aged between 12 and 17 years were included, all of whom met the inclusion/exclusion criteria. Of the total, 31.6% have Juvenile Idiopathic Arthritis (JIA)-14.33 +/- 2.25 years of age, whose subtypes included persistent oligoarticular JIA (16.7%), Polyarticular Rheumatoid Factor (RF) negative (33.3%), Polyarticular RF positive (16.7%) and Systemic (33.3%);68.4% have Systemic Lupus Erythematosus (SLE) -14.77 +/- 1.96 years of age. Regarding JIA patients, at inclusion, the mean disease activity assessed by the physician was 3 +/- 3.83 and 3.25 +/- 3.77 as assessed by the patient. After the 1st dose, the mean activity assessed by the physician was 2.8 +/- 3.9 and after the 2nd dose it was 3 +/- 4.24. Themean activity after the first dose as assessed by the patient was 3.2 +/- 3.96, and after the 2nd dose it was 2.8 +/- 3.11. In the SLE patients, at inclusion, the mean degree of disease activity was 1.92 +/- 1.83 and of the SLEDAI-2 K was 4.67 +/- 5.14. After the 1st dose, the mean disease activity was 1.11 +/- 1.96, and after the 2nd dose, it was 2.25 +/- 2.76. After the 1st dose, the SLEDAI-2 K was 1.11 +/- 1.76, and after the 2nd dose it was 4.25 +/- 5.28. No reports of worsening of disease activity after the vaccine were found. Conclusion(s): The vaccination proved not to contribute to worsening of clinical activity of rheumatic diseases in adolescents, without significant changes in SLE assessment indices and in the personal and medical assessment of JIA patients.
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Objectives: In the Chronic Inflammatory Immune-mediated Diseases (CIMD), infections mainly occur in the respiratory tract and their occurrence is related to drug-induced immunosuppression, underlying diseases and comorbidities. To reduce this morbidity and mortality, vaccination is an effective means of prevention. However, the available studies on SARS-CoV-2 vaccines have not addressed this group of patients with CIMD, and there are still many doubts regarding the indications, adverse effects, safety and efficacy of these vaccines. Objective(s): to evaluate the adverse effects of vaccines against SARS-CoV-2 in adolescent patients with CIMD. Method(s): Research associated to the SAFER Project from Brazilian Society of Rheumatology. It is an observational, longitudinal, ambidirectional study, with follow-up of groups of vaccinated adolescent patients with CIMD, vaccine by Pfizer/BioNTech. Sociodemographic data were collected, stored on an online platform, and adverse events were presented by filling in diaries issued for each patient. This study was approved by the local Research Ethics Committee. Result(s): We included 19 adolescents, aged between 12 to 17 years, who met the inclusion and exclusion criteria. The mean age was 14.63 +/- 2.01 years. Of these, 68.4% were female. In relation to CIMD, 31.6% have Juvenile Idiopathic Arthritis and 68.4% have Systemic Lupus Erythematosus. All were vaccinated with the Pfizer vaccine. In the 1st dose, the main adverse effects presented were Pain at the injection site (85.7%), Headache (42.9%), Tiredness (33.3%) and Edema and skin induration at the injection site (26, 7%). After the 2nd dose, the only adverse effect reported was Pain at the injection site (57.1%), with no other complaints. Conclusion(s): The adverse effects reported are of mild tomoderate reactogenicity;no serious adverse events were reported.
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Objectives: To evaluate the safety and immunogenicity of CoronaVac and ChAdOx1 vaccines against SARS-CoV-2 in patients with Rheumatoid Arthritis (RA). Method(s): These data are from the 'SAFER (Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases)' study, a Brazilian multicentric longitudinal phase IV study to evaluate COVID-19 vaccine in immunomediated rheumatic diseases (IMRDs). Adverse events (AEs) in patients with RA were assessed after two doses of ChAdOx1 or CoronaVac. Stratification of postvaccination AEs was performed using a diary, filled out daily. The titers of neutralizing antibodies against the receptor-biding domain of SARS-CoV-2 (anti-RBD) were measured by chemilumine scence test after each dose of immunizers. Proportions between groups were compared using the Chi-square and Fisher's exact tests for categorical variables. Clinical Disease Activity Index (CDAI) before and after vaccination was assessed using the McNemar test. Result(s): A total of 188 patients with RA were included in the study, most of them were female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed. The more common AEs after the first dose were pain at injection site (46,7%), headache (39,4%), arthralgia (39,4%) and myalgia (30,5%), and ChAdOx1 had a higher frequency of pain at the injection site (66% vs 32 %, p alpha 0.001) arthralgia (62% vs 22%, p alpha 0.001) and myalgia (45% vs 20%, p alpha 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection site (37%), arthralgia (31%), myalgia (23%) and headache (21%). Arthralgia (41,42 % vs 25 %, p = 0.02) and pain at injection site (51,43% vs 27%, p = 0.001) were more common with ChAdOx1. No patients had a flare after vaccination. The titers of anti-RBDafter two doses of ChAdOx1 were higher compared to two doses of CoronaVac (6,03 BAU/mL vs 4,67 BAU/mL, p alpha 0,001). Conclusion(s): The frequency of local adverse effects, particularly pain at injection site, was high. AEs were more frequent with ChAdOx1, especially after the first dose. The use of the immunizers dis not change the degree of inflammatory activity of the disease. In patients with RA, ChAdOx1 was more immunogenic than CoronaVac. .
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Objectives: Systemic lupus erythematosus (SLE) is an autoimmune disease which presents infections as one of the most frequent complications, including more severe outcomes of Coronavirus disease 2019 (COVID-19). Immunization of these patients has been strongly recommended, however, data on safety are still scarce. In this study we evaluate the safety after vaccination against SARS-CoV2 in patients with SLE. Method(s): Safety and Efficacy on COVID-19 Vaccine in Rheumatic Disease - the 'SAFER' study, is a longitudinal Brazilian multicenter phase IV study. In this study patients with SLE (according to the 2019 ACR/EULAR criteria), older than 18 years who received vaccination against SARS-CoV-2 CoronaVac (Inactivated SARS-CoV-2 Vaccine), ChadOx-1 (AstraZeneca) and BNT162b2 (Pfizer-BioNTech) were included. The evaluation of adverse events (AEs) was done by telephone contact, symptom diaries and a face-to-face visit on the 28th day after each dose. Patients were followed up also by disease activity, assessed using SLEDAI-2 K score. Result(s): A total of 367 individuals with SLE were included, 207 received CoronaVac, 128 received ChadOx-1 and 32 received BNT162b2. Ninety percent of the subjects were female with a mean age of 37 years. About 50% (182) of patients were using oral glucocorticoids and azathioprine was the most frequent immunosuppressive therapy. Regarding disease activity parameters, 38%(140) of patients had zero SLEDAI-2Kat baseline and 41%(147) had zero SLEDAI-2 K 28 days after the 2nd dose. After the first and second dose the most frequent AEs were pain at injection site (58%/44%), headache (48%/33%) and pruritus (42%/37%). Comparing the three vaccines, after the first dose, local symptoms, myalgia, and fever were less frequent in patients who received CoronaVac (p alpha 0.001) as well as headache, tiredness (p = 0.001) and arthralgia (p = 0.003). After the second dose, only local symptoms such as pain at the application site and thickening of the skin around the application site were less frequent in the CoronaVac group (p alpha 0.05). Headache, tiredness, musculoskeletal symptoms and fever were more common in patients receiving AstraZeneca. No serious adverse events were reported regardless of the vaccination schedule used. Conclusion(s): This study suggests that vaccines against SARS-COV-2 are safe in SLE patients. Neither severe AEs were reported nor worsening of disease activity were reported. Comparing the different vaccines, CoronaVac had fewer adverse events.
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Objectives: The use of glucocorticoids (GC) has been associated with increased risk of hospitalization for coronavirus infection and reduced immunogenicity of SARS-CoV-2 vaccines in immune-mediated diseases (IMD) patients. However, there is still controversy of which dose of GC is correlated with impaired vaccine response on each of the diverse COVID-19 vaccines available, as well as the possible influence of other concurrent immunosuppressants. This study aimed at evaluating the effect of GC on serological response after two doses of BNT162b2 (Pfizer/BioNTech), CoronaVac (inactivated SARS-CoV-2 Vaccine) and ChadOx1 (AstraZeneca) and after the booster dose in patients with IMD. Method(s): The data were extracted from a multicenter longitudinal observational Brazilian cohort (SAFER: Safety and Efficacy on COVID19 Vaccine in Rheumatic Disease). Patients >18 years of age with IMD were evaluated after 2 doses of the same vaccine against COVID-19 and after a booster vaccine, applied according to Brazilian National Immunization Program. All patients underwent clinical examination and collected blood samples for immunogenicity tests. Serological response was evaluated by Anti-RBD titers (IgG) at baseline and 4 weeks after each vaccine dose. Result(s): Among the 1009 patients evaluated, 301 were using GC (196/401 SLE, 52/199 RA and 27/74 vasculitis). Patients using GC were younger (38.2 vs 40,8 years, p = 0,002), had higherBMI (27,6 vs 26,4 p = 0,008), higher prevalence of kidney disease (3,3% vs 0,5%, p = 0,001) and of thrombosis (11,6% vs 5,9%, p = 0,002) than non-users. Regarding the type of vaccine, most of the GC users received CoronaVac (61.7%), while only 31.9%of non-users received this vaccine (p alpha 0.001). Although there were similar rates of pre-vaccination infections among them, patients with GC tended to have a higher incidence of confirmed COVID-19 infection after the 2nd dose of the vaccine compared to non-users (4.5% vs 2.0% p = 0.054). The antibody titers after the 1st dose of COVID-19 vaccines were similar between groups, but there was a worse response in the GC group after the 2nd dose (p = 0.039). However, this difference was not statistically significant after the 3rd dose (Figure). Conclusion(s): GC use may compromise vaccine-induced immunogenicity after a 2-dose regimen;however, this effect does not remain significant after the booster dose. Multivariate analysis is still pending to assess the potential difference in the impact of GC on the immune response depending on GC dose, type of vaccine and associated drugs.
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Objectives: To evaluate the immunogenicity of ChAdOx1, Coronavac and BNT162B2 vaccines in SLE patients, including homologous and heterologous immunizations. Method(s): The 'Safety and efficacy on COVID-19 Vaccine in Rheumatic Disease-SAFER study' is a Brazilian multicentric longitudinal phase IV study to evaluate COVID-19 Vaccine in immune-mediated rheumatic diseases (IMRD) in real life, started on May 2021. SLE patients (according to the 2012 SLICC classification criteria), older than 18 years of age were recruited after 2 or 3 doses of vaccine against COVID-19 (ChAdOx1, BNT162b2 and CoronaVac) and were evaluated at baseline and on the 28th day after each dose. Homologous immunization was considered if they received three doses of the same vaccine and heterologous if a different one was applied. IgG antibody against SARS-CoV-2 spike receptor-binding domain were measured by chemiluminescence (SARS-CoV-2-IgG-II Quant assay, Abbott-Laboratories) at baseline and 28 days after the first, 2nd and 3rd doses (Seropositivity IgGSpike>= 7.1BAU/mL). Statistical analysis: ANOVA and pairwise comparisons tests Results: 316 SLE patients were included (255 heterologous and 61 homologous immunization), 89.2% were female and the mean age was 37.6 +/- 11.2 years. The two groups were homogeneous regarding demographical data, disease activity and immunosuppressive treatment. 49.7% used corticosteroids (alpha 5 mg/day in 52.3%), 83.5% antimalarials, 22.8% azathioprine and 20.3% mycophenolate mofetil. 207 patients received the first two doses with CoronaVac, 128 ChadOx-1 and 32 BNT162b2. Regarding the first two doses of the same vaccine, there was no difference in IgG titers over time between CoronaVac or ChadOx-1 (p = 0.313). IgG titers increased in all vaccine groups, with difference only after 2nd dose: 4.96 +/- 1.71BAU/mL CoronaVac vs. 6.00 +/- 1.99BAU/mL ChadOx-1 vs. 7.31 +/- 1.49BAU/mL BNT162b2 (p alpha 0.001). There was no difference in IgG titers over time between homologous or heterologous vaccine schedule (p = 0.872). IgG titers also increased in all groups, with difference only after 2nd dose: 5.49 +/- 1.96BAU/mL heterologous vs. 6.30 +/- 2.10BAU/mL homologous (p = 0.009). Conclusion(s): Induction of immunogenicity occurred in different vaccine regimens in SLE patients. Future research to explore different heterologous schemes in IMRD must be performed.
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Objectives: Patients with immune-mediated rheumatic diseases (IMRD) constitute an important subgroup of immunosuppressed patients at risk of developing severe infections. Since coronavirus 19 infection (COVID-19) is an international public health emergency, it is necessary to observe the relationship between this viral infection and the development or intensification of the clinical course of IMRD and the persistence of new associated symptoms. The aim of this study is to trace this population's epidemiological profile and evaluate the frequency of chronic fatigue syndrome in patients with IMRD and COVID-19 compared to uninfected patients. Method(s): This is a descriptive cross-sectional observational study with a comparison group. The sociodemographic, clinical, and FACIT-F Fatigue Scale data were from patients with IMRD of Project Reumacov, organized by the Brazilian Society of Rheumatology, locally inManaus/Amazonas. The statistical analysis was performed through the inferential method to demonstrate the prevalence. Result(s): 268 patients were evaluated, those who had contact with COVID-19 had fatigue according with the fatigue assessment scale compared to unexposed patients. There was a statistically significant correlation between fatigue post-COVID-19 infection in the patients studied. Conclusion(s): Clinically relevant fatigue was a prevalent and commonly reported symptom in the post-COVID-19 period in the evaluated population. These data should direct attention to the reported manifestations as they affect the functioning of individuals' socioeconomic and health well-being throughout the pandemic period and beyond.
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Objective To evaluate the incidence of COVID-19 and its main outcomes in rheumatic disease (RD) patients on hydroxychloroquine (HCQ) compared to household cohabitants (HC).Methods This is a 24-week nationwide prospective multi-centre cohort with a control group without RD and not using HCQ. All participants were monitored through scheduled phone interviews performed by health professionals. Details regarding COVID-19 symptoms, and epidemiological, clinical, and demographic data were recorded on a specific web-based platform. COVID-19 was defined according to the Brazilian Ministry of Health criteria and classified as mild, moderate or severe.Results A total of 9,585 participants, 5,164 (53.9%) RD patients on HCQ and 4,421 (46.1%) HC were enrolled from March 29th, 2020 to September 30th, 2020, according to the eligibility criteria. COVID-19 confirmed cases were higher in RD patients than in cohabitants [728 (14.1%) vs. 427 (9.7%), p<0.001] in a 24-week follow-up. However, there was no significant difference regarding outcomes related to moderate/ severe COVID-19 (7.1% and 7.3%, respectively, p=0.896). After multiple adjustments, risk factors associated with hospitalisation were age over 65 (HR=4.5;95%CI 1.35-15.04, p=0.014) and cardiopathy (HR=2.57;95%CI 1.12-5.91, p=0.026). The final survival analysis demonstrated the probability of dying in 180 days after a COVID-19 diagnosis was significantly higher in patients over 65 years (HR=20.8;95%CI 4.5-96.1) and with 2 or more comorbidities (HR=10.8;95%CI 1.1-107.9 and HR=24.8;95%CI 2.5-249.3, p=0.006, respectively).Conclusion Although RD patients have had a higher COVID-19 incidence than individuals from the same epidemiological background, the COVID-19 severity was related to traditional risk factors, particularly multiple comorbidities and age, and not to underlying RD and HCQ.
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Objectives: To determine the main risk factors associated with COVID-19 in SLE patients. Methods: The Reuma CoV Brazil is a multicenter, observational, prospective cohort designed to monitor immune-mediated rheumatic diseases patients during SARS-CoV-2 pandemic in Brazil. SLE adult patients according to SLE SLICC criteria classification (2012), with and without (control group-CG) COVID-19 diagnosis were matched. Demographic data, managing of COVID-19, comorbidities, clinical characteristics (disease activity: Patient Report Outcomes-PROs, Physician Global Assessment and SLEDAI-2 K)were collected. Results: From May 2020 to January 2021, 604 SLE patients were included, 317 (52.4%) with COVID-19 and 287 (47.6%) in the CG. Both groups were homogeneous and comparable regarding sex and comorbidities. SLE patients with COVID-19 declared a lower level of social isolation (49.5% vs. 61.9%;p = 0.002), worked more commonly in health professions (10.4% vs. 3.5%;p = 0.002), presented more frequently joint (32.5% vs. 22.0%;p = 0.004) and hematological manifestations (18.0% vs. 11.5%;p = 0.025). SLEDAI-2 K did not differ among groups prior and after COVID-19 infection. However, considering the mean duration of COVID-19 symptoms (12.1 ± 8.8 days), infected patients had more severe disease activity's PROs after resolution of COVID-19 symptoms (2.9 ± 2.9 vs. 2.3 ± 2.6;p = 0.031). The hospitalization rate was 20.5% (n = 65), of whom 23 (7.2%) needed intensive care unit and 14 (4.4%) patients died. Hypertension [5,26 (1,9714,07);p = 0.001] and recently cyclophosphamide pulses [39,21 (4,17-368,53);p = 0.001] were associated with hospitalization and patients who received telemedicine medical care presented 72% less chance of hospitalization [0.28 (0.09-0.83);p = 0.023). Conclusion: COVID-19 was associated with a lower level of declared social isolation and more severe disease activity perception after SARS-CoV-2 infection according to PROs. Hypertension and cyclophosphamide were associated with hospitalization and telemedicine can be a useful tool for SLE patients with COVID-19. These data should be considered to perform public health policy and national guidelines to manage SLE patients during the pandemic, as well as to prioritize some special groups for the immunization program.
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OBJECTIVES: To evaluate the incidence of COVID-19 and its main outcomes in rheumatic disease (RD) patients on hydroxychloroquine (HCQ) compared to household cohabitants (HC). METHODS: This is a 24-week nationwide prospective multi-centre cohort with a control group without RD and not using HCQ. All participants were monitored through scheduled phone interviews performed by health professionals. Details regarding COVID-19 symptoms, and epidemiological, clinical, and demographic data were recorded on a specific web-based platform. COVID-19 was defined according to the Brazilian Ministry of Health criteria and classified as mild, moderate or severe. RESULTS: A total of 9,585 participants, 5,164 (53.9%) RD patients on HCQ and 4,421 (46.1%) HC were enrolled from March 29th, 2020 to September 30th, 2020, according to the eligibility criteria. COVID-19 confirmed cases were higher in RD patients than in cohabitants [728 (14.1%) vs. 427 (9.7%), p<0.001] in a 24-week follow-up. However, there was no significant difference regarding outcomes related to moderate/ severe COVID-19 (7.1% and 7.3%, respectively, p=0.896). After multiple adjustments, risk factors associated with hospitalisation were age over 65 (HR=4.5;95%CI 1.35-15.04, p=0.014) and cardiopathy (HR=2.57;95%CI 1.12-5.91, p=0.026). The final survival analysis demonstrated the probability of dying in 180 days after a COVID-19 diagnosis was significantly higher in patients over 65 years (HR=20.8;95%CI 4.5-96.1) and with 2 or more comorbidities (HR=10.8;95%CI 1.1-107.9 and HR=24.8;95%CI 2.5-249.3, p=0.006, respectively). CONCLUSIONS: Although RD patients have had a higher COVID-19 incidence than individuals from the same epidemiological background, the COVID-19 severity was related to traditional risk factors, particularly multiple comorbidities and age, and not to underlying RD and HCQ.