title: Infections in patients treated with tumor necrosis factor antagonists: incidence, etiology and mortality in the BIOBADASER registry.
abstract: OBJECTIVE
  Whether the use of tumor necrosis factor antagonists increases the risk of infection remains a subject of open debate. Developing effective strategies of prevention and empirical treatment entails carefully establishing the etiology and prognosis of the infections.
  
  
  METHODS
  Analysis of the Spanish registry BIOBADASER (Feb-2000 to Jan-2006), a national drug safety registry of patients with rheumatic diseases.
  
  
  RESULTS
  907 episodes of infection occurring in 6,969 patients were analyzed. The infection incidence observed was 53.09 cases/1,000 patients-years (CI 95% 49.69-56.66). The most frequent infections were skin infection (12.18 cases/1,000 patients-yrs), pneumonia (5.97 cases/1,000 patients-yrs), cystitis (3.92 cases/1,000 patients-yrs), tuberculosis (3.51 cases/1,000 patients-yrs) and arthritis (3.76 cases/1,000 patients-yrs). Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa and Salmonella spp. emerged as important pathogens. Varicella zoster virus and Herpes simplex virus caused most cases of viral infections. Mucocutaneous candidiasis accounted for most fungal infections. Mortality was increased in infected patients (log-rank test p<0.0001). Pneumonia, sepsis, tuberculosis, abdominal infection and endocarditis were associated with significant attributable mortality.
  
  
  CONCLUSIONS
  A significant number of bacterial, viral and fungal infections occurred in patients with rheumatic diseases treated with TNF antagonists. The information of this study can illuminate clinicians globally on how to address infection in this vulnerable group of patients.
authors.affiliation: Unit of Infectious Diseases, IMIBIC, Hospital Universitario Reina Sofía, University of Córdoba, Córdoba, Spain. selvahya@yahoo.es
authors.forename: María José
authors.initials: MJ
authors.lastname: Pérez-Sola
authors.forename: Julián
authors.initials: J
authors.lastname: Torre-Cisneros
authors.forename: Beatriz
authors.initials: B
authors.lastname: Pérez-Zafrilla
authors.forename: Loreto
authors.initials: L
authors.lastname: Carmona
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Descalzo
authors.forename: Juan Jesús
authors.initials: JJ
authors.lastname: Gómez-Reino
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use; D001170:Arthritis, Infectious / Q000453:epidemiology / Q000209:etiology; D001424:Bacterial Infections / Q000453:epidemiology / Q000209:etiology*; D015331:Cohort Studies; D004198:Disease Susceptibility; D005500:Follow-Up Studies; D006801:Humans; D016867:Immunocompromised Host; D015994:Incidence; D053208:Kaplan-Meier Estimate; D007896:Leishmaniasis / Q000453:epidemiology / Q000209:etiology; D009181:Mycoses / Q000453:epidemiology / Q000209:etiology*; D012042:Registries; D012141:Respiratory Tract Infections / Q000453:epidemiology / Q000209:etiology; D012216:Rheumatic Diseases / Q000188:drug therapy; D018805:Sepsis / Q000453:epidemiology / Q000209:etiology; D012874:Skin Diseases, Infectious / Q000453:epidemiology / Q000209:etiology; D013030:Spain / Q000453:epidemiology; D014376:Tuberculosis / Q000453:epidemiology / Q000209:etiology; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D014552:Urinary Tract Infections / Q000453:epidemiology / Q000209:etiology; D014777:Virus Diseases / Q000453:epidemiology / Q000209:etiology*
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha