Chronic use of hydroxychloroquine did not protect against COVID-19 in a large cohort of patients with rheumatic diseases in Brazil

Pileggi, Gecilmara Salviato; Ferreira, Gilda Aparecida; Reis, Ana Paula Monteiro Gomides; Reis-Neto, Edgard Torres; Abreu, Mirhelen Mendes; Albuquerque, Cleandro Pires; Araújo, Nafice Costa; Bacchiega, Ana Beatriz; Bianchi, Dante Valdetaro; Bica, Blanca; Bonfa, Eloisa Duarte; Borba, Eduardo Ferreira; Brito, Danielle Christinne Soares Egypto; Duarte, Ângela Luzia Branco Pinto; Santo, Rafaela Cavalheiro Espírito; Fernandes, Paula Reale; Guimarães, Mariana Peixoto; Gomes, Kirla Wagner Poti; Kakehasi, Adriana Maria; Klumb, Evandro Mendes; Lanna, Cristina Costa Duarte; Marques, Claudia Diniz Lopes; Monticielo, Odirlei André; Mota, Licia Maria Henrique; Munhoz, Gabriela Araújo; Paiva, Eduardo Santos; Pereira, Helena Lucia Alves; Provenza, José Roberto; Ribeiro, Sandra Lucia Euzébio; Junior, Laurindo Ferreira Rocha; Sampaio, Camila Santana Justo Cintra; Sampaio, Vanderson Souza; Sato, Emília Inoue; Skare, Thelma; de Souza, Viviane Angelina; Valim, Valeria; Lacerda, Marcus Vinícius Guimarães; Xavier, Ricardo Machado; Pinheiro, Marcelo Medeiros

BACKGROUND: There is a lack of information on the role of chronic use of hydroxychloroquine during the SARS-CoV-2 outbreak. Our aim was to compare the occurrence of COVID-19 between rheumatic disease patients on hydroxychloroquine with individuals from the same household not taking the drug during the first 8 weeks of community viral transmission in Brazil. METHODS: This baseline cross-sectional analysis is part of a 24-week observational multi-center study involving 22 Brazilian academic outpatient centers. All information regarding COVID-19 symptoms, epidemiological, clinical, and demographic data were recorded on a specific web-based platform using telephone calls from physicians and medical students. COVID-19 was defined according to the Brazilian Ministry of Health (BMH) criteria. Mann–Whitney, Chi-square and Exact Fisher tests were used for statistical analysis and two binary Final Logistic Regression Model by Wald test were developed using a backward-stepwise method for the presence of COVID-19. RESULTS: From March 29th to May 17st, 2020, a total of 10,443 participants were enrolled, including 5166 (53.9%) rheumatic disease patients, of whom 82.5% had systemic erythematosus lupus, 7.8% rheumatoid arthritis, 3.7% Sjögren’s syndrome and 0.8% systemic sclerosis. In total, 1822 (19.1%) participants reported flu symptoms within the 30 days prior to enrollment, of which 3.1% fulfilled the BMH criteria, but with no significant difference between rheumatic disease patients (4.03%) and controls (3.25%). After adjustments for multiple confounders, the main risk factor significantly associated with a COVID-19 diagnosis was lung disease (OR 1.63; 95% CI 1.03–2.58); and for rheumatic disease patients were diagnosis of systemic sclerosis (OR 2.8; 95% CI 1.19–6.63) and glucocorticoids above 10 mg/ day (OR 2.05; 95% CI 1.31–3.19). In addition, a recent influenza vaccination had a protective effect (OR 0.674; 95% CI 0.46–0.98). CONCLUSION: Patients with rheumatic disease on hydroxychloroquine presented a similar occurrence of COVID-19 to household cohabitants, suggesting a lack of any protective role against SARS-CoV-2 infection. Trial registration Brazilian Registry of Clinical Trials (ReBEC; RBR – 9KTWX6).