COVID-19 Impact on Patients with Immune-Mediated Rheumatic Disease: A Comparative Study of Disease Activity and Psychological Well-Being Over Six Months (preprint)

Objectives: To compare the impact of COVID-19 on clinical status and psychological condition in patients with immune-mediated rheumatic diseases (IMRD) infected by SARS-CoV-2 with IMRD controls not infected, during a 6-month follow-up. Methods: The ReumaCoV Brasil is a longitudinal study designed to follow-up IMRD patients for 6 months after COVID-19 (cases) compared with IMRD patients no COVID-19 (controls). Clinical data, disease activity measurements and current treatment regarding IMRD, and COVID-19 outcomes were evaluated in all patients. Disease activity was assessed through validated tools at inclusion and at 3 and 6 months post-COVID-19. The FACIT-F (Functional Assessment of Chronic Illness Therapy) and DASS 21 (Depression, Anxiety and Stress Scale - 21 Items) questionnaires were also applied at 6 months after COVID-19 in both groups before large-scale vaccination. The significance level was set as p<0.05, with a 95% confidence interval. Results: A total of 601 patients were evaluated, being 321 cases (IMRD COVID-19+) and 280 controls (IMRD COVID-19 -), predominantly female with similar median age. No significant differences were noted in demographic data between the groups, including comorbidities, disease duration, and IMRD. Disease activity assessment over a 6-month follow-up showed no significant difference between cases and controls. While mean activity scores did not differ significantly, some patients reported worsened disease activity post-COVID-19, particularly in rheumatoid arthritis (RA) (32.2%) and systemic lupus erythematosus (SLE) (23.3%). Post-COVID-19 worsening in RA patients correlated with medical global assessment (MGA) and CDAI scores, with a moderate to large effect size. Diabetes mellitus showed a positive association (OR=7.15), while TNF inhibitors showed a protective effect (OR=0.51). Comparing SLEDAI pre- and post-COVID-19, a minority showed increased scores, with few requiring treatment changes. Fatigue, depression, anxiety, and stress were significantly higher in cases compared to controls. Worsening disease activity post-COVID correlated with worsened FACIT-F and DASS-21 stress scale in RA patients. No significant associations were found between COVID-19 outcomes and post-COVID-19 disease activity or psychological assessments. Conclusions: Post-COVID-19 IMRD patients show significant psychological well-being deterioration despite similar disease activity scores. The variability in reports on IMRD flares and the potential trigger of SARS-CoV-2 for autoimmune manifestations underline the need for detailed clinical assessment and a comprehensive approach to managing them.

ReumaCoV Brasil Registry: Brazilian Study of Patients with Immuno-mediated Chronic Inflammatory Diseases Infected by SARS-CoV-2 (preprint)

Patients with immune-mediated rheumatic diseases (IMRD) are at increased risk of infections, including significant morbidity and high mortality. Considering the potential for unfavorable outcomes of SARS-CoV-2 infection in patients with IMRD, a huge number of questions were released regarding the impact of COVID-19 in the beginning of the pandemic. Seeking to better understand this complex interaction, this study was developed to evaluate prospectively patients with IMRD and a suspected or confirmed COVID-19 diagnosis, according to the Ministry of Health of Brazil’s definitions. The primary outcomes will be the IMRD disease activity changes after COVID-19, at four time points: (1) At baseline and prior 6 months; (2) The first rheumatic evaluation after known infection by SARS-CoV-2 (4-6 weeks); (3) 3 months after the inclusion (±15 days); (4) 6 months after inclusion (±15 days). The secondary outcomes will be the progression rate to severe forms of COVID-19, need for intensive care unit admission and mechanical ventilation, death and therapeutic changes related to the IMRD. Two outcomes are of particular interest considering the COVID-19 in IMRD patients, namely pulmonary and the thromboembolic events, and they will be monitored with more attention and details (clinical, lab, function tests and imaging). This protocol was approved by the Brazilian Committee of Ethics in Human Research (CONEP) on April 5th, 2020 (CAAE 30186820.2.1001.8807; Number: 3.933.204) and registered on the Brazilian Registry of Clinical Trials – REBEC (RBR-33YTQC) in June, 1st 2020. We believe this study will provide many clinically relevant data on the general impact of COVID-19 on IMRD patients.