The EULAR Study Group for Registers and Observational Drug Studies: comparability of the patient case mix in the European biologic disease modifying anti-rheumatic drug registers.

Abstract

OBJECTIVE:

Under the auspices of the European League Against Rheumatism (EULAR), a study group of investigators representing European biologic DMARD (bDMARD) registers was convened. The purpose of this initial assessment was to collect and compare a cross section of patient characteristics and collate information on the availability of potential confounders within these registers.

METHODS:

Baseline characteristics of patients starting their first bDMARD in an arbitrary year (2008) for the treatment of RA, including demographic and disease characteristics, bDMARD drug details and co-morbidities, were collected and compared across 14 European bDMARD registers.

RESULTS:

A total of 5320 patients were included. Half the registers had restricted recruitment to certain bDMARDs during the study year. All registers` collected data on age, gender, disease duration, seropositivity for IgM-RF and 28-joint DAS (DAS28). The mean DAS28 ranged from 4.2 to 6.6 and the mean HAQ from 0.8 to 1.9. Current smoking ranged from 9% to 34%. Nine registers reported co-morbidities with varying prevalence.

CONCLUSION:

In addition to demonstrating European-wide collaboration across rheumatology bDMARD registers, this assessment identified differences in prescribing patterns, recruitment strategies and data items collected. These differences need to be considered when applying strategies for combined analysis. The lack of a common data model across Europe calls for further work to harmonize data collection across registers.

• Authors: Lianne Kearsley-Fleet, Jakub Závada, Merete Lund Hetland, Dan C Nordström, Kalle J Aaltonen, Joachim Listing, Angela Zink, Tamas Gati, Bernadette Rojkovich, Florenzo Iannone, Elisa Gremese, Piet L C M van Riel, Martinus A F J van de Laar, Elisabeth Lie, Tore K Kvien, Helena Canhão, João E Fonseca, Žiga Rotar, Estibaliz Loza, Loreto Carmona, Johan Askling, Kari Johansson, Axel Finckh, William G Dixon, Kimme L Hyrich
• Journal: Rheumatology (Oxford, England) (Rheumatology (Oxford)) Vol. 54 Issue 6 Pg. 1074-1079 (Jun 2015) ISSN: 1462-0332 [Electronic] England
• PMID: 25433042 (Publication Type: Journal Article)
• Copyright: © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: [email protected].

Chemical References

• Antirheumatic Agents
• Biological Products

Topics

• Adult
• Antirheumatic Agents (therapeutic use)
• Arthritis, Rheumatoid (drug therapy)
• Biological Products (therapeutic use)
• Cross-Sectional Studies
• Diagnosis-Related Groups
• Europe
• Humans
• Registries (statistics & numerical data)
• Statistics as Topic