The REAL study: a nationwide prospective study of rheumatoid arthritis in Brazil

Abstract\ud \ud Background\ud There are few data on the epidemiology, clinical manifestations and management of RA in Brazil, even with the recognition of the high direct, indirect and societal costs of this disease. Herein, we report the formation of the REAL - Rheumatoid Arthritis in Real Life, the first nationally representative multicenter prospective observational study in Brazil.\ud \ud \ud Methods\ud The REAL study was designed to include a total of 1300 evaluable patients from 13 tertiary care public health centers specialized in RA management and representative of 5 regions of Brazil. Each center was expected to enroll ~ 100 consecutively seen patients and follow them prospectively in a systematic protocol-driven fashion with scheduled visits at baseline, 6 and 12 months. Core clinical, laboratory and patient-reported outcomes measures were required to be collected at each visit.\ud \ud \ud Results\ud A total of 1115 patients (89.4% female, mean age of 56.7 years and median disease duration of 12.7 years) were enrolled from 11 participating centers. Almost 80% of patients were of middle-low or low socioeconomic classes. The median educational time was 8 years, with 3.23% being below literacy level. The interval between symptoms and diagnosis varied from 1 to 457 months (median 12 months). Almost half of the patients were on glucocorticoids, 96.5% on DMARDs, with 35.7% on biologics. Median HAQ-DI was 0.875, ranging from 0 to 3. Median DAS28-ESR was 3.5, with 58.7% of patients presenting moderate or high disease activity.\ud \ud \ud Conclusions\ud The first large cohort of Brazilian patients with RA in a real-life setting shows several striking differences from previously published cohorts from other countries. The long delay for diagnosis and start of DMARDs may partly explain the high frequency of erosive disease. An elevated percentage of patients on moderate or high disease activity was seen, despite of the high frequency of corticosteroid and biologics utilization. Data from this cohort may enable public health managers of developing countries better allocate the limited resources available for the care of RA patients.This work was supported by the Brazilian Society of Rheumatology (BSR). For\ud this project, BSR received specific grant support from the following\ud companies: Bristol-Myers Squibb Farmacêutica Ltda; Eli Lilly do Brasil Ltda;\ud Janssen-Cilag Farmacêuticos Ltda; Laboratórios Pfizer Ltda; Produtos Roche\ud Químicos e Farmacêuticos S.A. and UCB Biopharma Ltda. The funding body\ud or the companies had no role in the design of the study and collection, analysis,\ud and interpretation of data and in writing the manuscript