title: A comparison of patient characteristics and outcomes in selected European and U.S. rheumatoid arthritis registries.
abstract: OBJECTIVE
  Randomized controlled trials (RCTs) have demonstrated the efficacy of biologic agents in the treatment of rheumatic diseases. However, results from RCTs may not be generalizable to clinical practice because of their strict inclusion and exclusion criteria. Assessment of safety using RCT data also is limited by short duration of follow-up and relatively small sample sizes, which generally preclude analysis of longer term outcomes and rare adverse events. In rheumatology, various observational cohorts and registries have been created to complement information obtained from RCTs, some with the primary purpose of monitoring effectiveness and safety of biologic agents. Most registries are either drug based or disease based. These registries include patients with a variety of rheumatic diseases including RA.
  
  
  METHODS
  To provide a qualitative comparison of selected U.S. and European rheumatoid arthritis (RA) biologics registries and cohorts including ARTIS, BIOBADASER, BSRBR, BRASS, CLEAR, CORRONA, NDB, RABBIT, SCQM, and VARA.
  
  
  RESULTS
  A careful comparison of these registries, as provided in this article, can provide a basis for understanding the many similarities and differences inherent in their design, as well as societal context and content, all of which can significantly impact their results and comparisons across registers.
  
  
  CONCLUSIONS
  The increasing use of biologic agents for treatment of rheumatic diseases has raised important questions about cost, safety, and effectiveness of these agents. The unique and variable features of patient populations and registry designs in Europe and the U.S. provide valuable and complementary data on comparative effectiveness and safety of biologic agents to what can be derived from RCTs.
authors.affiliation: Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA. jcurtis@uab.edu
authors.forename: Jeffrey R
authors.initials: JR
authors.lastname: Curtis
authors.forename: Archana
authors.initials: A
authors.lastname: Jain
authors.forename: Johan
authors.initials: J
authors.lastname: Askling
authors.forename: S Louis
authors.initials: SL
authors.lastname: Bridges
authors.forename: Loreto
authors.initials: L
authors.lastname: Carmona
authors.forename: William
authors.initials: W
authors.lastname: Dixon
authors.forename: Axel
authors.initials: A
authors.lastname: Finckh
authors.forename: Kimme
authors.initials: K
authors.lastname: Hyrich
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Greenberg
authors.forename: Joel
authors.initials: J
authors.lastname: Kremer
authors.forename: Joachim
authors.initials: J
authors.lastname: Listing
authors.forename: Kaleb
authors.initials: K
authors.lastname: Michaud
authors.forename: Ted
authors.initials: T
authors.lastname: Mikuls
authors.forename: Nancy
authors.initials: N
authors.lastname: Shadick
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Solomon
authors.forename: Michael E
authors.initials: ME
authors.lastname: Weinblatt
authors.forename: Fred
authors.initials: F
authors.lastname: Wolfe
authors.forename: Angela
authors.initials: A
authors.lastname: Zink
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000453:epidemiology / Q000378:metabolism; D005060:Europe / Q000453:epidemiology; D006801:Humans; D009017:Morbidity; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D014481:United States / Q000453:epidemiology
chemical_list: D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha