title: [Biobadaser 2.0: analysis and trends in 2009].
abstract: OBJECTIVE
  To update the information on long-term safety of biological therapies used for the treatment of rheumatic diseases.
  
  
  METHODS
  BIOBADASER is a safety registry of biological therapies established by the Spanish Society of Rheumatology. A description of BIOBADASER 2.0, a cohort composed of 14 centres within BIOBADASER is reported from 2000 until 2009.
  
  
  RESULTS
  The 14 centres have registered 5,493 patients, who have received 8,081 cycles of treatment with biological therapies. 30% (1,666) has received treatment with more than one biologic agent during follow-up. There have been 3,784 treatment discontinuations, with inefficacy or loss of efficacy being the most frequent cause (1,453; 38%), followed by adverse events (1,297; 34%). Up to 7,289 adverse events (AE) have been reported, of which 80% (5,764) were considered as non serious, nearly 19% (1,340) were notified as serious and about 2% (110) were fatal. The most frequent AE were infections (2,668; 37%), followed by general problems and administration related events (10%). Cardiovascular events and cancer amounted a 7% of the total AE.
  
  
  CONCLUSIONS
  There does not seem to be a trend regarding different risks in BIOBADASER 2.0 with respect to the general registry, or to previous years.
authors.affiliation: Unidad de Investigación, Sociedad Española de Reumatología, Madrid, España.
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Descalzo
authors.forename: Loreto
authors.initials: L
authors.lastname: Carmona