ABSTRACT
Background: Patients with inflammatory rheumatic diseases (IRD) infected with SARS-CoV-2 may be at risk to develop a severe course of COVID-19 due to the immune dysregulation or the influence of immunomodulating drugs on the course of the infection. For a better understanding of SARS-CoV-2 infections in patients with IRD and due to the high incidence of COVID-19 in Madrid from the beginning of this pandemic infection in Spain, the Society of Rheumatology from Madrid (SORCOM) established a registry (REUMA-COVID SORCOM) shortly after the beginning of the pandemic in Spain. Objectives: To determine factors associated with severity of infection with SARS-CoV-2 in patients with inflammatory rheumatic diseases in Madrid Methods: The REUMA-COVID SORCOM registry is a multicenter, retrospective, observational cohort study conducted in Madrid, a SORCOM initiative. All rheumatology departments from Madrid were invited to participate. The study includes patients with IRD presenting with a confirmed or highly suspected diagnosis of COVID-19 between March 1, 2020, and November 10, 2020. We consider severe infection death or need of hospitalization. Inclusion criteria was having an IRD and at least 1 of the following 4 criteria: (1) a biologically confirmed COVID-19 diagnosis based on a positive result of a SARS-CoV-2 polymerase chain reaction (PCR) test on a nasopharyngeal swab;(2) Detection of IgM or IgG anti SARSCoV2 in a symptomatic or asymptomatic patients (3)typical thoracic computed tomography (CT) abnormalities (ground-glass opacities) in epidemic areas;(4) COVID19-typical symptoms in an epidemic zone of COVID-19. Results: As of November 10, 2020, 417 patients with IRD were included in the REUMA-COVID SORCOM registry. 5 patients were discharged for incomplete data. Of 412 patients (mean age 57 years, 87.4% Caucasian race, 66.3% female) 174 need hospitalization (42.2%) and 33 patients died (18.4% mortality in hospitalized patients). 82.3% had comorbidities. 234 (56.8%) patients were classified as inflammatory arthropathy, 133 (32.3%) had connective tissue diseases (CTD). 41.1% of the patients had a large history of IRD (≥ 10 years). 10.4% of patients had previously pulmonary involvement. The study includes 143 patients taking Methotrexate, 89 patients taking anti-TNFα therapy and 27 Rituximab. In the univariant analysis, no differences were seen in the severity of COVID-19 infection in patients taking methotrexate. 63% of the all patients taking Rituximab included in the registry need hospitalization and 22% of them died. Hypertension, COPD or cardiovascular disease was associated with hospitalization. Independent factors associated with COVID-19 hospitalization in the multivariate analysis was: age (≥62 years), male sex, IMC ≥30, previous cardiovascular comorbidities and the IRD disease duration (≥ 10 years). Independent factors associated with COVID-19 related death was: age (≥ 62 years), having a CTD diagnose, pulmonary involvement before infection and chronical GC treatment. Conclusion: Patients with IRD represent a population of particular interest in the pandemic context because the baseline immunological alteration and the treated with immunosuppressants agents they receive, comorbidities and the well-known risk of severe infection. Older age, male sex, cardiovascular comorbidities were factors associated with high risk of hospitalization in IRD patients. CTD diseases, previously pulmonary involvement and chronical GC treatment with more than 10mg/day were associated with high risk of death. Neither anti TNF-α treatment nor Methotrexate were risk factor for hospitalization or death COVID-19 related in IRD patients.
ABSTRACT
Background: SARS-CoV-2 virus is a novel coronavirus that causes COVID-19 disease, which in its most severe form produces life-threatening atypical pneumonia and ARDS. Coronaviruses induce dysregulation of the immune system resulting in a cytokine storm syndrome with activation of the macrophage mediated mainly by IL-1 and IL-6. Although there is no specific treatment to date, researchers have explored novel approaches through targeting both IL-6 and IL-1. Anakinra is a recombinant human IL-1 receptor antagonist that prevents IL-1β and IL-1α binding and therefore blocks signal transduction. Its high bioavailability, rapid action, relatively short half-life and good safety profile make it a promising drug. Objectives: Analyse the experience of administering Anakinra for severe forms of COVID19 in patients hospitalised at a tertiary hospital. Methods: Retrospective single-center study in which all patients admitted for COVID-19 and treated with Anakinra from April 1st to the end of the 1st wave (July 2020) were included. Medical records were reviewed to collect demographic, clinical and lab test data, using Brescia-COVID respiratory severity scale, SaFi, CRP, Ferritin, LDH and lymphocytes. Variables were assessed at baseline, 72h and 7 days after treatment initiation. Descriptive statistical analysis was performed, including a sub-analysis of patients who received anakinra as the only biological treatment. Results: 54 patients were included, of which 37 male (68.5%) with a median age of 69.5 years (36-94). Comorbidities were lung disease 14 pts (25.9%), cardiovascular disease 39 pts (72.2%), Diabetes Mellitus 11 pts (20.4%), kidney disease and rheumatic disease each in 6 pts (11.1%), and immunosuppression 13 pts (24.1%). Each patient received a mean of 4.85 doses of anakinra (± 3.96). Other therapies included low-dose steroids (70.3%);high-dose steroids: 1mg/kg (87%), bolus (24%), Tocilizumab (57.4%), Infliximab (24.1%), Lopinavir/Ritonavir (48%), Hydroxychloroquine (94.4%), and Azithromycin (79.6%). Mortality was 22% overall, 75% due to COVID19, 8.3% due to infectious complications and 16.7% due to non-infectious complications. In the group receiving Anakinra as only biological drug, mortality accounted for 17.9% of patients, 75% due to COVID19 and 25% to non-infectious complications. No adverse effects related to anakinra were observed Conclusion: Anakinra in severe SARS-CoV-2 infection offers respiratory improvement and partial lab tests improvement. No adverse effects were observed.