A Comparison of Patient Characteristics and Outcomes in Selected European and US Rheumatoid Arthritis Registries

被引:156
作者
Curtis, Jeffrey R. [1 ]
Jain, Archana
Askling, Johan [2 ,3 ]
Bridges, S. Louis, Jr.
Carmona, Loreto [4 ]
Dixon, William [5 ]
Finckh, Axel [7 ]
Hyrich, Kimme [5 ]
Greenberg, Jeffrey D. [6 ]
Kremer, Joel [9 ,10 ]
Listing, Joachim [8 ]
Michaud, Kaleb [11 ]
Mikuls, Ted [13 ]
Shadick, Nancy [14 ]
Solomon, Daniel H. [14 ]
Weinblatt, Michael E. [14 ]
Wolfe, Fred [11 ]
Zink, Angela [8 ,12 ]
机构
[1] Univ Alabama Birmingham, Ctr Educ & Res Therapeut Musculoskeletal Dis CERT, Div Clin Immunol & Rheumatol, Birmingham, AL 35249 USA
[2] Karolinska Univ Hosp, Karolinska Inst, Dept Med Solna, Clin Epidemiol Unit, Stockholm, Sweden
[3] Karolinska Univ Hosp, Karolinska Inst, Rheumatol Unit, Stockholm, Sweden
[4] Spanish Fdn Rheumatol, Res Unit, Madrid, Spain
[5] Univ Manchester, Arthrit Res UK Epidemiol Unit, Manchester Acad Hlth Sci Ctr, Manchester, Lancs, England
[6] NYU Sch Med, New York, NY USA
[7] Univ Geneva, Div Rheumatol, Swiss Clin Qual Management Program SCQM, Geneva, Switzerland
[8] German Rheumatism Res Ctr Berlin, Berlin, Germany
[9] Albany Med Coll, Albany, NY 12208 USA
[10] Ctr Rheumatol, Albany, NY USA
[11] Natl Data Bank Rheumat Dis, Wichita, KS USA
[12] Charite Univ Med Berlin, Berlin, Germany
[13] Univ Nebraska Med Ctr, Omaha VA & Nebraska Arthrit Outcomes Res Ctr, Omaha, NE USA
[14] Brigham & Womens Hosp, Boston, MA 02115 USA
基金
美国国家卫生研究院;
关键词
rheumatoid arthritis; cohort; registry; epidemiology; safety; TUMOR-NECROSIS-FACTOR; SERIOUS BACTERIAL-INFECTIONS; FACTOR-ALPHA THERAPY; MYOCARDIAL-INFARCTION; FACTOR INHIBITORS; BRITISH-SOCIETY; RISK; DRUG; BIOLOGICS; COHORT;
D O I
10.1016/j.semarthrit.2010.03.003
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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. (C) 2010 Elsevier Inc. All rights reserved. Semin Arthritis Rheum 40:2-14
引用
收藏
页码:2 / 14
页数:13
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