title: Brazilian biologic registry: BiobadaBrasil implementation process and preliminary results.
abstract: OBJECTIVE
  The present study aimed at describing the implementation process of a national registry in a developing country (Brazil) and at reporting the main preliminary results of the BiobadaBrasil registry.
  
  
  METHODS
  Through a PANLAR agreement, the Biobadaser protocol was used as a model for implementing the new registry in our country. During the first two years of this effort, the original protocol was adapted, translated, and presented to all Brazilian rheumatologists. For ten months, data of 1,037 patients (750 subjects treated with biological drugs and 287 control subjects) from 15 centers were collected.
  
  
  RESULTS
  Most patients had rheumatoid arthritis (RA) (n = 723). Infliximab was the most frequently used anti-TNF agent, and the total exposure to biologic drugs was 2,101 patient-years. The most common reason for interrupting drug use was lack or loss of efficacy (50%), while 30% withdrew from the treatment arm due to adverse events. Three cases of tuberculosis were observed in the biologic group, with an incidence higher than that of the general Brazilian population. Infections were observed in 23% of the biologic group, and the upper respiratory tract was the most commonly affected site. Only one case of tuberculoid leprosy was observed. No deaths or malignancies attributed to drug effects were observed as of February 2010.
  
  
  CONCLUSIONS
  The implementation of the BiobadaBrasil registry was successful, and, although recent, the registry has provided important data.
authors.affiliation: Hospital das Clínicas Faculdade de Medicina, Universidade Federal do Paraná, Curitiba, PR, Brazil.
authors.forename: David C
authors.initials: DC
authors.lastname: Titton
authors.forename: Ines Guimarães
authors.initials: IG
authors.lastname: Silveira
authors.forename: Paulo
authors.initials: P
authors.lastname: Louzada-Junior
authors.forename: Andre L
authors.initials: AL
authors.lastname: Hayata
authors.forename: Hellen Mary S
authors.initials: HM
authors.lastname: Carvalho
authors.forename: Roberto
authors.initials: R
authors.lastname: Ranza
authors.forename: Lucila S
authors.initials: LS
authors.lastname: Rezende
authors.forename: Geraldo Castelar
authors.initials: GC
authors.lastname: Pinheiro
authors.forename: Jair Licio F
authors.initials: JL
authors.lastname: Santos
authors.forename: Jose Roberto
authors.initials: JR
authors.lastname: Miranda
authors.forename: Jozelio Freitas
authors.initials: JF
authors.lastname: Carvalho
authors.forename: Manoel Barros
authors.initials: MB
authors.lastname: Bertolo
authors.forename: Marlene
authors.initials: M
authors.lastname: Freire
authors.forename: Morton A
authors.initials: MA
authors.lastname: Scheinberg
authors.forename: Thelma L
authors.initials: TL
authors.lastname: Skare
authors.forename: Vander
authors.initials: V
authors.lastname: Fernandes
authors.forename: Washington
authors.initials: W
authors.lastname: Bianchi
authors.forename: Ieda Maria M
authors.initials: IM
authors.lastname: Laurindo
mesh_terms: D018501:Antirheumatic Agents; D001691:Biological Therapy; D001938:Brazil; D006801:Humans; D012042:Registries
chemical_list: D018501:Antirheumatic Agents