A comparison of patient characteristics and outcomes in selected European and U.S. rheumatoid arthritis registries.
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.
Curtis
Jeffrey R
JR
Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA. jcurtis@uab.edu
Jain
Archana
A
Askling
Johan
J
Bridges
S Louis
SL
Carmona
Loreto
L
Dixon
William
W
Finckh
Axel
A
Hyrich
Kimme
K
Greenberg
Jeffrey D
JD
Kremer
Joel
J
Listing
Joachim
J
Michaud
Kaleb
K
Mikuls
Ted
T
Shadick
Nancy
N
Solomon
Daniel H
DH
Weinblatt
Michael E
ME
Wolfe
Fred
F
Zink
Angela
A
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
D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha