Objectives and methodology of BIOBADASER phase III

Reumatología Clínica (English Edition) - Tập 15 - Trang 229-236 - 2019
Carlos Sanchez-Piedra1, M. Victoria Hernández Miguel2, Javier Manero3, Rosa Roselló4, Jesús Tomás Sánchez-Costa1, Carlos Rodríguez-Lozano5, Cristina Campos6, Eduardo Cuende7, Jesús Carlos Fernández-Lopez8, Sagrario Bustabad9, Raquel Martín Domenech10, Eva Pérez-Pampín11, Javier del Pino-Montes12, Ana Milena Millan-Arciniegas13, Federico Díaz-González1, Juan Jesús Gómez-Reino11
1Unidad de Investigación, Sociedad Española de Reumatología, Madrid, Spain
2Hospital Clínic de Barcelona, Barcelona, Spain
3Hospital Universitario Miguel Servet, Zaragoza, Spain
4Hospital General San Jorge, Huesca, Spain
5Hospital Universitario Dr. Negrín, Canarias, Spain
6Hospital General Universitario de Valencia, Valencia, Spain
7Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Madrid, Spain
8Complexo Hospitalario Universitario A Coruña, A Coruña, Spain
9Hospital Universitario de Canarias, Canarias, Spain
10Hospital General Universitario de Elda, Alicante, Spain
11Hospital Clínico Universitario de Santiago, Santiago, A Coruña, Spain
12Hospital Universitario de Salamanca, Salamanca, Spain
13Hospital de la Santa Creu I Sant Pau, Barcelona, Spain

Tài liệu tham khảo

Gabriel, 2009, Epidemiological studies in incidence, prevalence, mortality, and comorbidity of the rheumatic diseases, Arthritis Res Ther, 11, 229, 10.1186/ar2669 Episer, 2001 Rheumatology SCoBRUSSo, 2015 Chen, 2006, A systematic review of the effectiveness of adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis in adults and an economic evaluation of their cost-effectiveness, Health Technol Assess, 10, 1, 10.3310/hta10420 Inman, 2008, Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial, Arthritis Rheum, 58, 3402, 10.1002/art.23969 Marzo-Ortega, 2005, Infliximab in combination with methotrexate in active ankylosing spondylitis: a clinical and imaging study, Ann Rheum Dis, 64, 1568, 10.1136/ard.2004.022582 Shepherd, 2016, The clinical effectiveness and cost-effectiveness of abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis: a systematic review and economic evaluation, Health Technol Assess, 20, 1, 10.3310/hta20340 Giardina, 2010, A 2-year comparative open label randomized study of efficacy and safety of etanercept and infliximab in patients with ankylosing spondylitis, Rheumatol Int, 30, 1437, 10.1007/s00296-009-1157-3 Curtis, 2011, Use of biologics in rheumatoid arthritis: current and emerging paradigms of care, Clin Ther, 33, 679, 10.1016/j.clinthera.2011.05.044 2014 2014 2016 2016 Carmona, 2005, [Spanish registry of adverse events of biological therapies in rheumatic diseases (BIOBADASER): report as of january 14, 2005], Reumatol Clin, 1, 95, 10.1016/S1699-258X(05)72722-4 Curtis, 2010, A comparison of patient characteristics and outcomes in selected European and US rheumatoid arthritis registries, Semin Arthritis Rheum, 40, 10.1016/j.semarthrit.2010.03.003 Carmona, 2005, Effectiveness of recommendations to prevent reactivation of latent tuberculosis infection in patients treated with tumor necrosis factor antagonists, Arthritis Rheum, 52, 1766, 10.1002/art.21043 Gómez-Reino, 2007, Risk of tuberculosis in patients treated with tumor necrosis factor antagonists due to incomplete prevention of reactivation of latent infection, Arthritis Care Res, 57, 756, 10.1002/art.22768 Gómez-Reino, 2003, Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report, Arthritis Rheumatol, 48, 2122, 10.1002/art.11137 Sundararajan, 2004, New ICD-10 version of the Charlson comorbidity index predicted in-hospital mortality, J Clin Epidemiol, 57, 1288, 10.1016/j.jclinepi.2004.03.012 Naranjo, 1981, Naranjo ADR probability scale, Clin Pharmacol Ther, 30, 239, 10.1038/clpt.1981.154 Symmons, 2011, Lessons for clinical practice from biologics registers, Rheumatology, 50, 10.1093/rheumatology/ker046 Iannone, 2017, Body mass does not impact the clinical response to intravenous abatacept in patients with rheumatoid arthritis, Clin Rheumatol, 36, 773, 10.1007/s10067-016-3505-5 Chatzidionysiou, 2016, Effectiveness of two different doses of rituximab for the treatment of rheumatoid arthritis in an international cohort, Arthritis Res Ther, 18, 1 Gottenberg, 2016, Brief report: Association of rheumatoid factor and anti-citrullinated protein antibody positivity with better effectiveness of abatacept: results from the Pan-European Registry Analysis, Arthritis Rheumatol, 68, 1346, 10.1002/art.39595 Gabay, 2016, Effectiveness of tocilizumab with and without synthetic disease-modifying antirheumatic drugs in rheumatoid arthritis: results from a European collaborative study, Ann Rheum Dis, 75, 1336, 10.1136/annrheumdis-2015-207760 García-Doval, 2017, Should tumour necrosis factor antagonist safety information be applied from patients with rheumatoid arthritis to psoriasis? Rates of serious adverse events in the prospective rheumatoid arthritis BIOBADASER and psoriasis BIOBADADERM cohorts, Br J Dermatol, 176, 146, 10.1111/bjd.14776 Carmona, 2014, BIOBADASER, BIOBADAMERICA, and BIOBADADERM: safety registers sharing commonalities across diseases and countries, Clin Exp Rheumatol, 32 De la Vega, 2013, The importance of rheumatology biologic registries in Latin America, Rheumatol Int, 33, 827, 10.1007/s00296-012-2610-2 Gomez-Reino, 2017