A Comparison of Patient Characteristics and Outcomes in Selected European and U.S. Rheumatoid Arthritis Registries1

Jeffrey R. Curtis, Archana Jain, Johan Askling, S. Louis Bridges, Loreto Carmona, William Dixon, Axel Finckh, Kimme Hyrich, Jeffrey D. Greenberg, Joel Kremer, Joachim Listing, Kaleb D Michaud, Ted R Mikuls, Nancy Shadick, Daniel H. Solomon, Michael E. Weinblatt, Fred Wolfe, Angela Zink

Research output: Contribution to journalArticle

122 Citations (Scopus)

Abstract

Purpose: 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. Summary: 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.

Original languageEnglish (US)
Pages (from-to)2-14.e1
JournalSeminars in Arthritis and Rheumatism
Volume40
Issue number1
DOIs
StatePublished - Jan 1 2010

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Registries
Rheumatoid Arthritis
Biological Factors
Randomized Controlled Trials
Rheumatic Diseases
Safety
Rheumatology
Biological Products
Sample Size
Cost-Benefit Analysis
Rabbits
Therapeutics
Pharmaceutical Preparations
Population

Keywords

  • Cohort
  • Epidemiology
  • Registry
  • Rheumatoid arthritis
  • Safety

ASJC Scopus subject areas

  • Rheumatology
  • Anesthesiology and Pain Medicine

Cite this

A Comparison of Patient Characteristics and Outcomes in Selected European and U.S. Rheumatoid Arthritis Registries1 . / Curtis, Jeffrey R.; Jain, Archana; Askling, Johan; Bridges, S. Louis; Carmona, Loreto; Dixon, William; Finckh, Axel; Hyrich, Kimme; Greenberg, Jeffrey D.; Kremer, Joel; Listing, Joachim; Michaud, Kaleb D; Mikuls, Ted R; Shadick, Nancy; Solomon, Daniel H.; Weinblatt, Michael E.; Wolfe, Fred; Zink, Angela.

In: Seminars in Arthritis and Rheumatism, Vol. 40, No. 1, 01.01.2010, p. 2-14.e1.

Research output: Contribution to journalArticle

Curtis, JR, Jain, A, Askling, J, Bridges, SL, Carmona, L, Dixon, W, Finckh, A, Hyrich, K, Greenberg, JD, Kremer, J, Listing, J, Michaud, KD, Mikuls, TR, Shadick, N, Solomon, DH, Weinblatt, ME, Wolfe, F & Zink, A 2010, 'A Comparison of Patient Characteristics and Outcomes in Selected European and U.S. Rheumatoid Arthritis Registries1 ', Seminars in Arthritis and Rheumatism, vol. 40, no. 1, pp. 2-14.e1. https://doi.org/10.1016/j.semarthrit.2010.03.003
Curtis, Jeffrey R. ; Jain, Archana ; Askling, Johan ; Bridges, S. Louis ; Carmona, Loreto ; Dixon, William ; Finckh, Axel ; Hyrich, Kimme ; Greenberg, Jeffrey D. ; Kremer, Joel ; Listing, Joachim ; Michaud, Kaleb D ; Mikuls, Ted R ; Shadick, Nancy ; Solomon, Daniel H. ; Weinblatt, Michael E. ; Wolfe, Fred ; Zink, Angela. / A Comparison of Patient Characteristics and Outcomes in Selected European and U.S. Rheumatoid Arthritis Registries1 In: Seminars in Arthritis and Rheumatism. 2010 ; Vol. 40, No. 1. pp. 2-14.e1.
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