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

https://doi.org/10.1016/j.semarthrit.2010.03.003Get rights and content

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.

Section snippets

Selection of Registries and Cohorts

While recognizing the existence of numerous RA registries, we identified published articles that report comparable data for the domains described above, with a particular focus on registries and cohorts that allowed for addressing questions related to patient characteristics and comorbidities and the effectiveness, safety, and adherence to biologics used for the treatment of RA. Based largely on size, the European registries selected for this qualitative comparison included the U.K. British

Recruitment Methods and Inclusion Criteria

Table 1 summarizes the governance, nature of data reported, frequency of data collection, and selection criteria of the various cohorts. The European registers initiated by the national rheumatology societies of the respective countries had widely varied inclusion criteria for the biologic and comparator cohorts. The biologic arms generally enroll new users, although new disease-modifying antirheumatic drug (DMARD) use is often not required for the comparator cohorts. U.K. national guidelines

Conclusion

Because results from RCTs may not be generalizable to clinical practice, biologics registries and cohorts have been set up in various countries to bridge the gap in our knowledge regarding the effectiveness and safety of these agents. The large size of these registries and long duration of follow-up allows analysis of rare events, which generally is not possible with RCTs. Our work highlighting the unique features of several of these cohorts points out their various characteristics that may

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    The following authors have made disclosures: J.C.: research grants: Amgen, Novartis, UCB, Centocor; consulting: Roche, UCB, CORRONA, Amgen; J.A.: speakers honoraria <$2000 from Wyeth, BMS, Abbott, Centocor, Schering-Plough; A.F.: research grants: Roche, Wyeth; Consulting: Roche, Abbott, Essex, Wyeth; J.L., J.G.: Dr. Greenberg serves as Chief Scientific Officer for CORRONA and has served on Advisory Boards for BMS, Centocor, Genentech, Roche and UCB; A.Z.: research grants: Abbott, Amgen, BMS, Schering-Plough, Roche, UCB, Wyeth; T.M.: research grants: Abbott, Amgen, UCB, (VARA); consulting: UCB; N.S. research grants: Biogen Idec, Crescendo Biosciences, Amgen; M.W. research grants: Biogen Idec, Crescendo Bioscience; consulting: Biogen Idec, Crescendo Bioscience.

    All other authors have no conflicts or relevant disclosures.

    This work was supported by the Doris Duke Charitable Foundation. Some of the investigators receive support from the National Institutes of Health (AR053351: J.R.C.; AR047782 and AG027066: D.H.S.).

    1

    Authors contributed data from their respective registries and to the editing of the manuscript; aside from the first 2 authors, authors are listed alphabetically.

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