原创力文档rates of, and risk factors for, severe infections in patients with systemic autoimmune diseases receiving biological agents off-label率和风险因素,严重感染的系统性自身免疫性疾病患者接受生物制剂标示外.pdfVIP
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rates of, and risk factors for, severe infections in patients with systemic autoimmune diseases receiving biological agents off-label率和风险因素,严重感染的系统性自身免疫性疾病患者接受生物制剂标示外
Díaz-Lagares et al. Arthritis Research Therapy 2011, 13:R112
/content/13/4/R112
RESEARCH ARTICLE Open Access
Rates of, and risk factors for, severe infections in
patients with systemic autoimmune diseases
receiving biological agents off-label
1† 2† 3 4
Cándido Díaz-Lagares , Roberto Pérez-Alvarez , Francisco J García-Hernández , María M Ayala-Gutiérrez ,
José Luis Callejas5 6 7 8 9
, Agustín Martínez-Berriotxoa , Javier Rascón , Luis Caminal-Montero , Albert Selva-O’Callaghan ,
Joaquim Oristrell 10, Carmen Hidalgo11, Ricardo Gómez-de-la-Torre12, Luis Sáez13, Jesús Canora-Lebrato14,
María-Teresa Camps4 5 3 1*
, Norberto Ortego-Centeno , María-Jesús Castillo-Palma and Manuel Ramos-Casals for
the BIOGEAS Study Group
Abstract
Introduction: The purpose of this observational study was to analyze the rates, characteristics and associated risk
factors of severe infections in patients with systemic autoimmune diseases (SAD) who were treated off-label with
biological agents in daily practice.
Methods: The BIOGEAS registry is an ongoing Spanish prospective cohort study investigating the long-term safety
and efficacy of the off-label use of biological agents in adult patients with severe, refractory SAD. Severe infections
were defined according to previous studies as those that required intravenous treatment or that led to
hospitalization or death. Patients contributed person-years of follow
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