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Background/objectiveThis study describes the impact of immunomodulatory and/or immunosuppressive (IM/IS) drugs in the outcomes of COVID-19 infection in a cohort of patients with immune-mediated inflammatory diseases (IMIDs).MethodsAdult patients with IMIDs with a confirmed SARS-CoV-2 infection were included. Data were reported by the treating physician between August 13, 2020 and July 31, 2021. Sociodemographic data, comorbidities, and DMARDs, as well as clinical characteristics, complications, and treatment of the SARS-CoV-2 infection, were recorded. Descriptive analysis and multivariable logistic regression models were carried out.ResultsA total of 1672 patients with IMIDs were included, of whom 1402 were treated with IM/IS drugs. The most frequent diseases were rheumatoid arthritis (47.7%) and systemic lupus erythematosus (18.4%). COVID-19 symptoms were present in 95.2% of the patients. A total of 461 (27.6%) patients were hospitalized, 8.2% were admitted to the intensive care unit, and 4.4% died due to COVID-19.Patients without IM/IS treatment used glucocorticoids less frequently but at higher doses, had higher levels of disease activity, were significantly older, were more frequently hospitalized, admitted to the intensive care unit, and died due to COVID-19. After adjusting for these factors, treatment with IM/IS drugs was not associated with a worse COVID-19 outcome (World Health Organization-Ordinal Scale ≥5) (odds ratio, 1.24; 95% confidence interval, 0.73-2.06).ConclusionsSAR-COVID is the first multicenter Argentine registry collecting data from patients with rheumatic diseases and SARS-CoV-2 infection. After adjusting for relevant covariates, treatment with IM/IS drugs was not associated with severe COVID-19 in patients with IMIDs.Study registrationThis study has been registered in ClinicalTrials.gov under the number NCT04568421.

This study aims to describe the course and to identify poor prognostic factors of SARS-CoV-2 infection in patients with rheumatic diseases.Patients ≥ 18 years of age, with a rheumatic disease, who had confirmed SARS-CoV-2 infection were consecutively included by major rheumatology centers from Argentina, in the national, observational SAR-COVID registry between August 13, 2020 and July 31, 2021. Hospitalization, oxygen requirement, and death were considered poor COVID-19 outcomes.A total of 1915 patients were included. The most frequent rheumatic diseases were rheumatoid arthritis (42%) and systemic lupus erythematosus (16%). Comorbidities were reported in half of them (48%). Symptoms were reported by 95% of the patients, 28% were hospitalized, 8% were admitted to the intensive care unit (ICU), and 4% died due to COVID-19. During hospitalization, 9% required non-invasive mechanical ventilation (NIMV) or high flow oxygen devices and 17% invasive mechanical ventilation (IMV). In multivariate analysis models, using poor COVID-19 outcomes as dependent variables, older age, male gender, higher disease activity, treatment with glucocorticoids or rituximab, and the presence of at least one comorbidity and a greater number of them were associated with worse prognosis. In addition, patients with public health insurance and Mestizos were more likely to require hospitalization.In addition to the known poor prognostic factors, in this cohort of patients with rheumatic diseases, high disease activity, and treatment with glucocorticoids and rituximab were associated with worse COVID-19 outcomes. Furthermore, patients with public health insurance and Mestizos were 44% and 39% more likely to be hospitalized, respectively.This study has been registered in ClinicalTrials.gov under the number NCT04568421. Key Points • High disease activity, and treatment with glucocorticoids and rituximab were associated with poor COVID-19 outcome in patients with rheumatic diseases. • Some socioeconomic factors related to social inequality, including non-Caucasian ethnicity and public health insurance, were associated with hospitalization due to COVID-19.

To evaluate the efficacy and safety of SARS-CoV-2 vaccine in patients with rheumatic and immune-mediated inflammatory diseases (IMIDs) in Argentina: the SAR-CoVAC registry.SAR-CoVAC is a national, multicenter, and observational registry. Adult patients with rheumatic or IMIDs vaccinated for SARS-CoV-2 were consecutively included between June 1 and September 17, 2021. Sociodemographic data, comorbidities, underlying rheumatic or IMIDs, treatments received, their modification prior to vaccination, and history of SARS-CoV-2 infection were recorded. In addition, date and place of vaccination, type of vaccine applied, scheme, adverse events (AE), disease flares, and new immune-mediated manifestations related to the vaccine were analyzed.A total of 1234 patients were included, 79% were female, with a mean age of 57.8 (SD 14.1) years. The most frequent diseases were rheumatoid arthritis (41.2%), osteoarthritis (14.5%), psoriasis (12.7%), and spondyloarthritis (12.3%). Most of them were in remission (28.5%) or low disease activity (41.4%). At the time of vaccination, 21% were receiving glucocorticoid treatment, 35.7% methotrexate, 29.7% biological (b) disease modifying anti-rheumatic drugs (DMARD), and 5.4% JAK inhibitors. In total, 16.9% had SARS-CoV-2 infection before the first vaccine dose. Most patients (51.1%) received Gam-COVID-Vac as the first vaccine dose, followed by ChAdOx1 nCoV-19 (32.8%) and BBIBP-CorV (14.5%). Half of them (48.8%) were fully vaccinated with 2 doses; 12.5% received combined schemes, being the most frequent Gam-COVID-Vac/mRAN-1273. The median time between doses was 51 days (IQR 53). After the first dose, 25.9% of the patients reported at least one AE and 15.9% after the second, being flu-like syndrome and local hypersensitivity the most frequent manifestations. There was one case of anaphylaxis. Regarding efficacy, 63 events of SARS-CoV-2 infection were reported after vaccination, 19% occurred during the first 14 days post-vaccination, 57.1% after the first dose, and 23.8% after the second. Most cases (85.9%) were asymptomatic or mild and 2 died due to COVID-19.In this national cohort of patients, the most common vaccines used were Gam-COVID-Vac and ChAdOx1 nCoV-19. A quarter of the patients presented an AE and 5.1% presented SARS-CoV-2 infection after vaccination, in most cases mild.This study has been registered in ClinicalTrials.gov under the number: NCT04845997. Key Points • This study shows real-world data about efficacy and safety of SARS-CoV-2 vaccination in patients with rheumatic and immune-mediated inflammatory diseases. Interestingly, different types of vaccines were used including vector-based, mRNA, and inactivated vaccines, and mixed regimens were enabled. • A quarter of the patients presented an adverse event. The incidence of adverse events was significantly higher in those receiving mRAN-1273 and ChAdOx1 nCoV-19. • In this cohort, 5.1% presented SARS-CoV-2 infection after vaccination, in most cases mild.

Introducción: el lupus eritematoso sistémico (LES) es una enfermedad sistémica que se ha asociado a mayor severidad con la infección por SARS-CoV-2. Particularmente la alta actividad de la enfermedad y algunos inmunosupresores se han vinculado a peores desenlaces. Objetivos: describir las características por SARS-CoV-2 en pacientes con LES en Argentina del registro SAR-COVID y establecer los factores asociados a peor desenlace de la misma. Materiales y métodos: estudio observacional. Se incluyeron pacientes con diagnóstico de LES con infección confirmada por SARS-CoV-2 (RT-PCR y/o serología positiva) del registro SAR-COVID. Los datos se recolectaron desde agosto de 2020 hasta marzo de 2022. El desenlace de la infección se midió mediante la escala ordinal de la Organización Mundial de la Salud (EO-OMS). Se definió COVID-19 severo con un valor EO-OMS ≥5. Análisis descriptivo, test T de Student, U de Mann Whitney U, ANOVA, chi2 y Fisher. Regresión logística múltiple. Resultados: se incluyeron 399 pacientes, el 93% de sexo femenino, con una edad media de 40,9 años (DE 12,2). El 39,6% tenía al menos una comorbilidad. Al momento de la infección, el 54,9% recibía glucocorticoides, el 30,8% inmunosupresores y el 3,3% agentes biológicos. La infección por SARS-CoV-2 fue leve en la mayoría de los casos, mientras que un 4,6% tuvo curso severo y/o falleció. Estos últimos presentaban comorbilidades, usaban glucocorticoides y tenían síndrome antifosfolípido (SAF) con mayor frecuencia y mayor actividad de la enfermedad al momento de la infección. En el análisis multivariado, la hipertensión arterial, el diagnóstico de SAF y el uso de glucocorticoides se asociaron a hospitalización severa y/o muerte por COVID-19 (EO-OMS ≥5). Conclusiones: en esta cohorte de pacientes con LES con infección por SARS-CoV-2 confirmada, la mayoría cursó de manera sintomática, un 22,1% fue hospitalizado y un 5% requirió ventilación mecánica. La mortalidad fue cercana al 3%. El diagnóstico de SAF, tener hipertensión arterial y el uso de glucocorticoides se asociaron significativamente con COVID-19 severo.

Introducción: los pacientes con artritis psoriásica (APs) presentan más comorbilidades. Las guías del Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) establecen lineamientos para los tratamientos de acuerdo a ellas. Objetivos: describir la prevalencia de comorbilidades en pacientes con APs según el Rheumatic Disease Comorbidity Index (RDCI), analizar el efecto sobre la enfermedad y estudiar la adherencia a las guías GRAPPA. Materiales y métodos: estudio observacional. Se incluyeron pacientes con APs de la cohorte RAPSODIA. Se reportaron características sociodemográficas y clínicas. Las comorbilidades se valoraron por RDCI. Se estudiaron variables asociadas a RDCI ≥1 mediante análisis multivariado. Se analizó el cumplimiento de las recomendaciones de tratamiento en relación a las comorbilidades según las guías GRAPPA. Resultados: se incluyeron 170 pacientes. El 67,6% presentó al menos una comorbilidad (RDCI ≥1); estos eran de mayor edad (X 57,3±12,7 años vs. 48,2±13,2 años; p

ObjectiveThe aim of this study was to assess the immune response after a third dose of SARS-CoV-2 vaccine in patients with rheumatoid arthritis (RA) with undetectable antibody titers after the primary regimen of 2 doses.MethodsPatients with RA with no seroconversion after 2 doses of SARS-CoV-2 vaccine and who received a third dose of either an mRNA or vector-based vaccine were included. Anti-SARS-CoV-2 IgG antibodies, neutralizing activity, and T cell responses were assessed after the third dose.ResultsA total of 21 nonresponder patients were included. At the time of vaccination, 29% were receiving glucocorticoids and 85% biologic disease-modifying antirheumatic drugs (including 6 taking abatacept [ABA] and 4 taking rituximab [RTX]). The majority (95%) received the BNT162b2 vaccine and only one of them received the ChAdOx1 nCoV-19 vaccine. After the third dose, 91% of the patients presented detectable anti-SARS-CoV-2 IgG and 76% showed neutralizing activity. Compared to other treatments, ABA and RTX were associated with the absence of neutralizing activity in 4 out of 5 (80%) patients and lower titers of neutralizing antibodies (median 3, IQR 0-20 vs 8, IQR 4-128;P= 0.20). Specific T cell response was detected in 41% of all patients after the second dose, increasing to 71% after the third dose. The use of ABA was associated with a lower frequency of T cell response (33% vs 87%,P= 0.03).ConclusionIn this RA cohort, 91% of patients who failed to seroconvert after 2 doses of SARS-CoV-2 vaccine presented detectable anti-SARS-CoV-2 IgG after a third dose. The use of ABA was associated with a lower frequency of specific T cell response.

Resumen Introducción: un tercio de los pacientes con artritis psoriásica (APs) sufre ansiedad y/o depresión, lo que podría impactar negativamente en la actividad de la enfermedad. Los objetivos de este estudio fueron: evaluar la prevalencia de depresión y ansiedad en pacientes con APs, estudiar su asociación con diferentes factores socio-demográficos y clínicos, y determinar el efecto sobre los diferentes componentes de los índices compuestos de la actividad de la APs. Materiales y métodos: se incluyeron pacientes con APs que cumplían criterios de la Classification Criteria of Psoriatic Arthritis (CASPAR). La depresión se definió según el Patient Health Questionnaire-9 (PHQ-9) y la ansiedad según el cuestionario General Anxiety Disorder-7 (GAD-7). Se realizó regresión logística múltiple para identificar variables asociadas a ansiedad y depresión. Resultados: se incluyeron 100 pacientes con APs, de los cuales el 26% y el 59% presentaron depresión mayor y ansiedad respectivamente. Los pacientes con depresión mayor tuvieron mayor actividad de la enfermedad, dolor, fatiga, ansiedad, y menor educación formal y peor calidad de vida. Aquellos con ansiedad manifestaron mayor actividad de la enfermedad, dolor y fatiga, y peor calidad de vida y capacidad funcional. La alta actividad de la enfermedad y la menor educación formal se asociaron independientemente con depresión mayor. Conclusiones: la presencia de depresión mayor y ansiedad se asoció con mayor actividad de la enfermedad en pacientes con APs. Abstract Introduction: nearly one-third of psoriatic arthritis (PsA) patients suffer from anxiety and/or depression. The objectives of this study were to estimate the prevalence of depression and anxiety in patients with PsA, establish the relationship with different socio-demographic and clinical factors, and determine the effect of depression and anxiety on various components of disease activity scores. Materials and methods: patients with PsA who met the Classification criteria of psoriatic arthritis (CASPAR) criteria were included. Depression was defined according to the Patient Health Questionnaire-9 (PHQ-9) and anxiety according to the General Anxiety Disorder-7 (GAD-7) questionnaire. Multiple logistic regression was performed to identify variables associated with anxiety and depression. Results: 100 patients were included. The prevalence of major depression and anxiety was 26% and 59%, respectively. Patients with major depression had higher disease activity, pain, fatigue and anxiety, less formal education and worse quality of life. In comparison those patients with anxiety showed higher disease activity, pain and fatigue and worse quality of life and functional capacity. High disease activity and low formal education were independently associated with the existence of major depression. Conclusions: patients with PsA who suffer from major depression and anxiety show higher disease activity levels.

Depression is one of the most frequent comorbidity in patients with Rheumatoid Arthritis (RA). It´s presence is associated with higher healthcare costs, mortality rate and reduced odds of achieving a good treatment response. Objective: to determine the prevalence of depression in Argentinean patients with RA and to establish its relationship with different sociodemographic and clinical factors. Material and methods: consecutive patients ≥18 years old, with a diagnosis of RA according to ACR-EULAR 2010 criteria were included. Sociodemographic data, comorbidities, RA characteristics, disease activity and current treatment were registered. Questionnaires were administered: EQ-5D-3L, QOL-RA, HAQ-A and PHQ-9. PHQ-9 scores of 5-9, 10-14, 15-19, ≥20 represent mild, moderate, moderate/severe and severe depression, respectively and a cut-off value ≥10, major depression. Statistical analysis: Student´s T, ANOVA and Chi2 tests. Multiple logistic regression.

We have recently validated the Quality of Life-Rheumatoid Arthritis Scale (QOL-RA). We have found some limitations, that is why, with the author’s permission, we have changed two questions and developed a new Spanish version, QOL-RA II. Objective: to validate the QOL-RA II in an Argentinean cohort of patients with Rheumatoid Arthritis (RA). Material and methods: cross-sectional study. Patients ≥18 years old, with a diagnosis of RA according to ACR-EULAR 2010 criteria were included. Sociodemographic data, comorbidities, RA characteristics, disease activity current treatment were registered. Questionnaires were administered: EQ-5D-3L, QOL-RA, HAQ-A and PHQ-9. The QOL-RA II was re-administered in 20 patients to evaluate reproducibility. Statistical analysis: Student´s T, ANOVA and Chi2 tests. Spearman correlation. Cronbach´s alpha. Reproducibility using ICC. Multinomial logistic regression with completed factorial model. Multiple linear regression.

ObjectiveTo investigate baseline use of biologic or targeted synthetic (b/ts) disease-modifying antirheumatic drugs (DMARDs) and COVID-19 outcomes in rheumatoid arthritis (RA).MethodsWe analysed the COVID-19 Global Rheumatology Alliance physician registry (from 24 March 2020 to 12 April 2021). We investigated b/tsDMARD use for RA at the clinical onset of COVID-19 (baseline): abatacept (ABA), rituximab (RTX), Janus kinase inhibitors (JAKi), interleukin 6 inhibitors (IL-6i) or tumour necrosis factor inhibitors (TNFi, reference group). The ordinal COVID-19 severity outcome was (1) no hospitalisation, (2) hospitalisation without oxygen, (3) hospitalisation with oxygen/ventilation or (4) death. We used ordinal logistic regression to estimate the OR (odds of being one level higher on the ordinal outcome) for each drug class compared with TNFi, adjusting for potential baseline confounders.ResultsOf 2869 people with RA (mean age 56.7 years, 80.8% female) on b/tsDMARD at the onset of COVID-19, there were 237 on ABA, 364 on RTX, 317 on IL-6i, 563 on JAKi and 1388 on TNFi. Overall, 613 (21%) were hospitalised and 157 (5.5%) died. RTX (OR 4.15, 95% CI 3.16 to 5.44) and JAKi (OR 2.06, 95% CI 1.60 to 2.65) were each associated with worse COVID-19 severity compared with TNFi. There were no associations between ABA or IL6i and COVID-19 severity.ConclusionsPeople with RA treated with RTX or JAKi had worse COVID-19 severity than those on TNFi. The strong association of RTX and JAKi use with poor COVID-19 outcomes highlights prioritisation of risk mitigation strategies for these people.

El autocuestionario QOL-RA es una herramienta diseñada para valorar la calidad de vida de los pacientes con Artritis Reumatoidea (AR). No requiere licencia para su uso. Objetivo: validar el cuestionario QOL-RA en una cohorte de pacientes con AR en Argentina.

Key Points Question Is receipt of tumor necrosis factor (TNF) inhibitor monotherapy at the time of COVID-19 diagnosis associated with adverse COVID-19 outcomes compared with other treatment regimens among patients with immune-mediated inflammatory diseases (IMIDs)? Findings In this cohort study of 6077 patients with IMIDs and COVID-19, TNF inhibitors in combination with azathioprine/6-mercaptopurine therapy, methotrexate monotherapy, azathioprine/6-mercaptopurine monotherapy, or Janus kinase inhibitor monotherapy were each associated with significantly higher odds of hospitalization or death compared with TNF inhibitor monotherapy. Meaning This study’s findings support the continued use of TNF inhibitor monotherapy among individuals with IMIDs during the pandemic., Importance Although tumor necrosis factor (TNF) inhibitors are widely prescribed globally because of their ability to ameliorate shared immune pathways across immune-mediated inflammatory diseases (IMIDs), the impact of COVID-19 among individuals with IMIDs who are receiving TNF inhibitors remains insufficiently understood. Objective To examine the association between the receipt of TNF inhibitor monotherapy and the risk of COVID-19–associated hospitalization or death compared with other commonly prescribed immunomodulatory treatment regimens among adult patients with IMIDs. Design, Setting, and Participants This cohort study was a pooled analysis of data from 3 international COVID-19 registries comprising individuals with rheumatic diseases, inflammatory bowel disease, and psoriasis from March 12, 2020, to February 1, 2021. Clinicians directly reported COVID-19 outcomes as well as demographic and clinical characteristics of individuals with IMIDs and confirmed or suspected COVID-19 using online data entry portals. Adults (age ≥18 years) with a diagnosis of inflammatory arthritis, inflammatory bowel disease, or psoriasis were included. Exposures Treatment exposure categories included TNF inhibitor monotherapy (reference treatment), TNF inhibitors in combination with methotrexate therapy, TNF inhibitors in combination with azathioprine/6-mercaptopurine therapy, methotrexate monotherapy, azathioprine/6-mercaptopurine monotherapy, and Janus kinase (Jak) inhibitor monotherapy. Main Outcomes and Measures The main outcome was COVID-19–associated hospitalization or death. Registry-level analyses and a pooled analysis of data across the 3 registries were conducted using multilevel multivariable logistic regression models, adjusting for demographic and clinical characteristics and accounting for country, calendar month, and registry-level correlations. Results A total of 6077 patients from 74 countries were included in the analyses; of those, 3215 individuals (52.9%) were from Europe, 3563 individuals (58.6%) were female, and the mean (SD) age was 48.8 (16.5) years. The most common IMID diagnoses were rheumatoid arthritis (2146 patients [35.3%]) and Crohn disease (1537 patients [25.3%]). A total of 1297 patients (21.3%) were hospitalized, and 189 patients (3.1%) died. In the pooled analysis, compared with patients who received TNF inhibitor monotherapy, higher odds of hospitalization or death were observed among those who received a TNF inhibitor in combination with azathioprine/6-mercaptopurine therapy (odds ratio [OR], 1.74; 95% CI, 1.17-2.58; P = .006), azathioprine/6-mercaptopurine monotherapy (OR, 1.84; 95% CI, 1.30-2.61; P = .001), methotrexate monotherapy (OR, 2.00; 95% CI, 1.57-2.56; P, This cohort study uses data from 3 international registries to examine the association between the receipt of tumor necrosis factor monotherapy and the risk of COVID-19–associated hospitalization or death among adult patients with immune-mediated inflammatory diseases.

To validate the Quality of Life-Rheumatoid Arthritis Scale II (QOL-RA II) in an Argentinean cohort of patients with rheumatoid arthritis (RA). Patients ≥ 18 years old, with a diagnosis of RA according to ACR-EULAR 2010 criteria, were included in a cross-sectional study. Sociodemographic data, comorbidities, RA characteristics, disease activity, and current treatment were registered. Questionnaires were administered, including EQ-5D-3 L, QOL-RA II, HAQ-A, and PHQ-9. The QOL-RA II was re-administered in 20 patients to evaluate reproducibility. Four hundred and thirty patients were included. Median QOL-RA was 6.6 (IQR 5.3-8). Mean time to complete it was 1.7 ± 0.57 min and to calculate it was 12 ± 1.7 s. It showed very good reliability (Cronbach's alpha 0.97), reproducibility (ICC, 0.96), and good correlation between the different items and the total questionnaire, without evidence of redundancy. Besides, QOL-RA II presented good correlation with EQ-5D-3L (Rho, 0.6) and moderate with DAS28 (Rho, 0.38), and CDAI (Rho, 0.46). Worse quality of life was observed in patients not doing physical activity, unemployed, and current smokers. Patients with higher disease activity had a significant poorer quality of life. Adjusting by age, sex and disease duration, unemployment, higher disease activity, disability, and the presence of depression were independently associated to worse quality of life. QOL-RA II demonstrated good construct validity, reproducibility, and reliability. It was easy to complete and calculate and does not require a license for its use, thus making it the optimal tool for assessing the quality of life in Spanish-speaking patients with RA. Key Points • The evaluation of quality of life is very important in patients with Rheumatoid Arthritis. • Most of the questionnaires used to assess the quality of life require a license to use. • QOL-RA II is a valid and simple questionnaire to evaluate the quality of life of patients with RA and does not require a license for its use.

Intermediate uveitis is described as inflammation in the anterior vitreous, ciliary body and the peripheral retina. It is a subset of uveitis where the vitreous is the major site of damage. It has been reported to be associated with many local and systemic inflammatory and infectious diseases. An infrequent cause is the tubulointerstitial nephritis and uveitis syndrome. We report a case of an acute visual acuity loss related with renal failure in a 64 years old woman with Hashimoto disease. It was an acute tubulointerstitial nephritis and uveitis syndrome case.