Safety and Survival Associated with Biologic Therapies: First Report of the Biobadaguay on the Paraguayan-Uruguayan Registry of Adverse Events with Biologic Therapies. / Seguridad y supervivencia de las terapias biológicas: primer informe del registro paraguayo-uruguayo de acontecimientos adversos con terapias biológicas Biobadaguay.

OBJECTIVE: Analyze adverse events (AE) and survival associated with biologic therapies (BT) in the Biobadaguay, the Paraguayan Uruguayan registry of adverse events. METHODS: Prospective, observational study of undetermined duration. Patients on BT at initiation and controls were included. Clinical, biological and treatment variables were registered. RESULTS: A total of 826 registers were entered (650 BT and 176 controls); 70.9% were women and rheumatoid arthritis (RA) was the most frequent diagnosis (63.2%). The BT most often used was adalimumab and the main cause of discontinuation was loss of efficacy (42.1%). The incidence of AE of patients on BT was 143.9 (128.8-160.8) per 1000 patients/year. In the comparative study of AE related to diagnosis, juvenile idiopathic arthrosis (JIA) was associated with a higher overall number of AE (RTI = 2.3; 95%CI: 1.6-3.4; P = 4.27 ×10-6), whereas RA was associated with a higher number of serious AE (RTI = 2.2; 95% CI: 1.2-4.1; P =1.17 ×10-2). On the other hand, treatment with tocilizumab was associated with a higher rate of AE (RTI = 2.69; 95% CI: 1.9-3.82; P = 3.13 ×10-8). In JIA, treatment with corticosteroids and number of previous BT was associated with a decrease in BT survival. CONCLUSION: In this first report of the Biobadaguay registry, the main cause of BT discontinuation was loss of efficacy. In terms of the diagnosis involved, RA and JIA were associated with a higher risk of AE. In this registry, variables related to a shorter survival of BT were identified.

Characteristics of Patients With Early-Onset Arthritis in Latin America: Description of the REPANARC Cohort.

BACKGROUND: While many studies have tried to show that early intervention improves the clinical outcomes of early-onset arthritis, only a few were carried out in Latin America. OBJECTIVES: The aim of this study was to describe the Pan-American Registry of Early-Onset Arthritis (REPANARC) project and report the preliminary outcomes of a cohort of patients. METHODS: The REPANARC cohort consisted of a sample of patients from 6 Latin American countries. Patients with arthritis of 1 or more joints of 1-year duration or less were assessed by a rheumatologist during 6 consecutive clinical visits for a follow-up period of 2 years. The registry included clinical characteristics, medical history, physical examination, disease activity, analytical chemistries, imaging, current treatment, and a set of patient-reported outcome measures evaluating disability, psychological distress, and quality of life. RESULTS: A total of 173 patients were included with mean age of 41.9 ± 13.2 years; 83.8% were women. The predominant presentations at onset were insidious, polyarticular, additive, bilateral, and symmetrical. The initial diagnoses were rheumatoid arthritis (50.6%), undifferentiated arthritis (40.5%), and other arthritis (8.9%). With Disease Activity Score in 28 Joints, 76.9% had moderate to high disease activity, and 61.9% had moderate to severe disability (Health Assessment Questionnaire). Considering undifferentiated arthritis, 60.3% persisted undifferentiated, 29.4% evolved as rheumatoid arthritis, 4.4% remained self-limited, and 5.9% to other forms. The frequencies of depression and anxiety were high as measured with the Hospital Anxiety and Depression Scale, and approximately 20% had significant decrements in quality of life measured with the Medical Outcomes Study Short-Form 36 Health Survey Version 2. Mean time from the first symptoms to the first visit to a rheumatologist was 126 days. Shorter delays were confirmed to be associated with better outcomes. CONCLUSIONS: The REPANARC project is a useful tool to provide valuable information regarding patients with early-onset arthritis attending rheumatology centers in Latin-America.