Objectives and methodology of BIOBADASER phase iii.
Por:
Sanchez-Piedra C, Hernández Miguel MV, Manero J, Roselló R, Sánchez-Costa JT, Rodríguez-Lozano C, Campos C, Cuende E, Fernández-Lopez JC, Bustabad S, Martín Domenech R, Pérez-Pampín E, Del Pino-Montes J, Millan-Arciniegas AM, Díaz-González F, Gómez-Reino JJ and en representación del Grupo de trabajo BIOBADASER Fase III
Publicada:
1 jul 2019
Ahead of Print:
19 sep 2017
Resumen:
OBJECTIVE: Describe 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). METHODOLOGY: Multicenter 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. RESULTS: During the first year, 35 centers participated. The number of patients included in this new phase in December 2016 was 2,664. 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. CONCLUSIONS: BIOBADASER 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.
Filiaciones:
Sanchez-Piedra C:
Unidad de Investigación, Sociedad Española de Reumatología, Madrid, España
Hernández Miguel MV:
Hospital Clínic de Barcelona, Barcelona, España
Manero J:
Hospital Universitario Miguel Servet, Zaragoza, España
Roselló R:
Hospital General San Jorge, Huesca, España
Sánchez-Costa JT:
Unidad de Investigación, Sociedad Española de Reumatología, Madrid, España
Rodríguez-Lozano C:
Hospital Universitario Dr. Negrín, Canarias, España
Campos C:
Hospital General Universitario de Valencia, Valencia, España
Cuende E:
Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Madrid, España
Fernández-Lopez JC:
Complexo Hospitalario Universitario A Coruña, A Coruña, España
Bustabad S:
Hospital Universitario de Canarias, Canarias, España
Martín Domenech R:
Hospital General Universitario de Elda, Alicante, España
Pérez-Pampín E:
Hospital Clínico Universitario de Santiago, Santiago, A Coruña, España
Del Pino-Montes J:
Hospital Universitario de Salamanca, Salamanca, España
Millan-Arciniegas AM:
Hospital de la Santa Creu i Sant Pau, Barcelona, España
Díaz-González F:
Unidad de Investigación, Sociedad Española de Reumatología, Madrid, España
Gómez-Reino JJ:
Hospital Clínico Universitario de Santiago, Santiago, A Coruña, España
|