TY - JOUR T1 - Objectives and methodology of BIOBADASER phase III JO - Reumatología Clínica (English Edition) T2 - AU - Sanchez-Piedra,Carlos AU - Hernández Miguel,M. Victoria AU - Manero,Javier AU - Roselló,Rosa AU - Sánchez-Costa,Jesús Tomás AU - Rodríguez-Lozano,Carlos AU - Campos,Cristina AU - Cuende,Eduardo AU - Fernández-Lopez,Jesús Carlos AU - Bustabad,Sagrario AU - Martín Domenech,Raquel AU - Pérez-Pampín,Eva AU - del Pino-Montes,Javier AU - Millan-Arciniegas,Ana Milena AU - Díaz-González,Federico AU - Gómez-Reino,Juan Jesús SN - 21735743 M3 - 10.1016/j.reumae.2017.08.005 DO - 10.1016/j.reumae.2017.08.005 UR - https://reumatologiaclinica.org/en-objectives-methodology-biobadaser-phase-iii-articulo-S2173574319300449 AB - ObjectiveDescribe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III). MethodologyMulticenter prospective registry of patients with rheumatic inflammatory diseases being treated with biological drugs or synthetic drugs with an identifiable target in rheumatology departments in Spain. The main objective of BIOBADASER phase III is the registry and analysis of adverse events; moreover, a secondary objective was added consisting of assessing the effectiveness by means of the registry of activity indexes. Patients in the registry are evaluated at least once every year and whenever they experience an adverse event or a change in treatment. The collection of data for phase III began on 17 December 2015. ResultsDuring the first year, 35 centres participated. The number of patients included in this new phase in December 2016 was 2664. The mean age was 53.7 years and the median duration of treatment was 8.1 years. In all, 40.4% of the patients were diagnosed with rheumatoid arthritis. The most frequent adverse events were infections and infestations. ConclusionsBIOBADASER phase III has been launched to adapt to a changing pharmacological environment, with the introduction of biosimilars and small molecules in the treatment of rheumatic diseases. This new stage is adapted to the changes in the reporting of adverse events and now includes information related to activity scores. ER -