Objectives and methodology of BIOBADASER phase III
Por:
Sanchez-Piedra, C, Miguel, M, Manero, J, Rosello, R, Sanchez-Costa, J, Rodriguez-Lozano, C, Campos, C, Cuende, E, Fernandez-Lopez, J, Bustabad, S, Domenech, R, Perez-Pampin, E, del Pino-Montes, J, Millan-Arciniegas, A, Diaz-Gonzalez, F, Gomez-Reino, J, Marsal, S, Sellas, A, Rodriguez, B, Barcelo, M, Farietta, S, Navarro, F, Ruiz, D, Vargas, M, Beltran, C, Marzo, J, Medrano, M, Pecondon, A, Lesta, A, Vazquez, C, Guanabens, N, Hernandez, M, Sanmarti, R, Inciarte, J, Canete, J, Rodriguez, C, Naranjo, A, Ojeda, S, Hernandez, F, Quevedo, J, Erausquin, C, Hernandez, C, Rua, I, Fernandez, A, Manrique, S, Irigoyen, M, Urena, I, Garcia, B, Calvo, J, de Vicuna, R, Ortiz, A, Mateo, I, Rodriguez, E, Garcia, J, Gonzalez, C, Lopez, F, Valor, L, Nieto, J, Raya, E, Notario, I, Soto, M, Caliz, R, Diaz-Torne, C, Milian, A, Moya, P, Castellvi, I, Laiz, A, Vela, P, Cano, R, Martin, R, Sivera, F, Garcia, L, Blanco, J, Galindez, E, de Toro, F, Freire, M, Fernandez, J, Cogolludo, V, Morales, J, Rodriguez, F, Miguelez, R, Fernandez, C, Medina, J, Sanchez, M, Villa, C, Gonzalez, C, Mas, A, Toniolo, E, Cacheda, A, Ros, I, Ibanez, M, Gonzalez, M, Martinez, V, Pina, T, Palmou, N, del Pino, J, Perez, L, Martinez, O, Hidalgo, C, Quesada, A, Manzano, G, Montilla, C, Munoz, S, Illera, O and Grp Trabajo BIOBADASER Fase III
Publicada:
1 jul 2019
Ahead of Print:
19 sep 2017
Categoría:
Rheumatology
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 10 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. (C) 2017 Elsevier Espafia, S.L.U. and Sociedad Espafiola de Reumatologia y Colegio Mexicano de Reumatologia. All rights reserved.
Filiaciones:
Sanchez-Piedra, C:
Soc Espanola Reumatol, Unidad Invest, Madrid, Spain
Miguel, M:
Hosp Clin Barcelona, Barcelona, Spain
Manero, J:
Hosp Univ Miguel Servet, Zaragoza, Spain
Rosello, R:
Hosp Gen San Jorge, Huesca, Spain
Sanchez-Costa, J:
Soc Espanola Reumatol, Unidad Invest, Madrid, Spain
Rodriguez-Lozano, C:
Hosp Univ Dr Negrin, Canarias, Spain
Campos, C:
Hosp Gen Univ Valencia, Valencia, Spain
Cuende, E:
Hosp Univ Principe Asturias, Madrid, Spain
Fernandez-Lopez, J:
Complexo Hosp Univ Coruna, La Coruna, Spain
Bustabad, S:
Hosp Univ Canarias, Canarias, Spain
:
Hosp Gen Univ Elda, Alicante, Spain
Perez-Pampin, E:
Hosp Clin Univ Santiago, Santiago, A Coruna, Spain
del Pino-Montes, J:
Hosp Univ Salamanca, Salamanca, Spain
Millan-Arciniegas, A:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Diaz-Gonzalez, F:
Soc Espanola Reumatol, Unidad Invest, Madrid, Spain
Gomez-Reino, J:
Hosp Clin Univ Santiago, Santiago, A Coruna, Spain
Marsal, S:
Hosp Univ Vall dHebron, Barcelona, Spain
Sellas, A:
Hosp Univ Vall dHebron, Barcelona, Spain
Rodriguez, B:
Hosp Univ Vall dHebron, Barcelona, Spain
Barcelo, M:
Hosp Univ Vall dHebron, Barcelona, Spain
Farietta, S:
Hosp Univ Vall dHebron, Barcelona, Spain
Navarro, F:
Hosp Univ Virgen Marcena, Seville, Spain
Ruiz, D:
Hosp Univ Virgen Marcena, Seville, Spain
Vargas, M:
Hosp Univ Virgen Marcena, Seville, Spain
Beltran, C:
Hosp Univ Miguel Servet, Zaragoza, Spain
Marzo, J:
Hosp Univ Miguel Servet, Zaragoza, Spain
Medrano, M:
Hosp Univ Miguel Servet, Zaragoza, Spain
Pecondon, A:
Hosp Univ Miguel Servet, Zaragoza, Spain
Lesta, A:
Hosp Univ Miguel Servet, Zaragoza, Spain
Vazquez, C:
Hosp Univ Miguel Servet, Zaragoza, Spain
Guanabens, N:
Hosp Clin Barcelona, Barcelona, Spain
Hernandez, M:
Hosp Clin Barcelona, Barcelona, Spain
Sanmarti, R:
Hosp Clin Barcelona, Barcelona, Spain
Inciarte, J:
Hosp Clin Barcelona, Barcelona, Spain
Canete, J:
Hosp Clin Barcelona, Barcelona, Spain
Rodriguez, C:
Hosp Gran Canaria Dr Negrin, Las Palmas Gran Canaria, Spain
Naranjo, A:
Hosp Gran Canaria Dr Negrin, Las Palmas Gran Canaria, Spain
Ojeda, S:
Hosp Gran Canaria Dr Negrin, Las Palmas Gran Canaria, Spain
Hernandez, F:
Hosp Gran Canaria Dr Negrin, Las Palmas Gran Canaria, Spain
Quevedo, J:
Hosp Gran Canaria Dr Negrin, Las Palmas Gran Canaria, Spain
Erausquin, C:
Hosp Gran Canaria Dr Negrin, Las Palmas Gran Canaria, Spain
Hernandez, C:
Hosp Gran Canaria Dr Negrin, Las Palmas Gran Canaria, Spain
Rua, I:
Hosp Gran Canaria Dr Negrin, Las Palmas Gran Canaria, Spain
Fernandez, A:
Hosp Gen Carlos Haya, Malaga, Spain
Manrique, S:
Hosp Gen Carlos Haya, Malaga, Spain
Irigoyen, M:
Hosp Gen Carlos Haya, Malaga, Spain
Urena, I:
Hosp Gen Carlos Haya, Malaga, Spain
Garcia, B:
Hosp Gen San Jorge, Huesca, Spain
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