Safety and Survival Associated with Biologic Therapies: First Report of the Biobadaguay on the Paraguayan-Uruguayan Registry of Adverse Events with Biologic Therapies

• Published in: Reumatología clinica (Barcelona) Vol. 16; no. 5 Pt 2; pp. 396 - 404
• Main Authors: de Abreu, Paloma, Ávila-Pedretti, Gabriela, Morel, Zoilo, Acosta, María Isabel, Cabrera-Villalba, Sonia, Melgarejo, Patricia, Franco, Marco, Delgadillo, Pedro, Román, Lourdes, Elizaur, Juan Gabriel, Paredes, Ernesto, Cordovilla, Darwin Octavio, Palleiro, Daniel, Albanese, Miguel, Mazzoleni, Julio
• Format: Journal Article
• Language: English; Spanish
• Published: 01-09-2020
• ISSN: 2173-5743
• DOI: 10.1016/j.reuma.2018.08.009

OBJECTIVEAnalyze adverse events (AE) and survival associated with biologic therapies (BT) in the Biobadaguay, the Paraguayan Uruguayan registry of adverse events. METHODSProspective, observational study of undetermined duration. Patients on BT at initiation and controls were included. Clinical, biological and treatment variables were registered. RESULTSA 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. CONCLUSIONIn 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.