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Rheumatology (Oxford). 2015 Jun;54(6):1074-1079. doi: 10.1093/rheumatology/keu446. Epub 2014 Nov 27.

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.

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Arthritis Research UK Centre for Epidemiology, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK, 2Institute of Rheumatology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic, 3DANBIO, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Glostrup Hospital, 4Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark, 5 Department of Medicine, Helsinki University Central Hospital, 6Faculties of Pharmacy and Medicine, University of Helsinki, Helsinki, Finland, 7German Rheumatism Research Centre, Epidemiology Unit, Berlin, 8German Rheumatism Research Centre, Epidemiology Unit and Charité University Medicine, Berlin, Germany, 9Department of Rheumatology, Semmelweis University, Polyclinic of the Hospitaller Brothers of St John of God, Budapest, Hungary,10Rheumatology Unit, Interdisciplinary Department of Medicine, School of Medicine, University of Bari, Italy, 11Institute of Rheumatology and Affine Sciences, Division of Rheumatology, Catholic University of the Sacred Heart, Rome, Italy, 12Radboud University Medical Center, Rheumatology, Nijmegen, 13Arthritis Centre Twente, Medisch Spectrum Twente & University Twente, Department of Psychology Health and Technology, Enschede, The Netherlands, 14Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 15Rheumatology Research Group, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Portugal, 16Hospital de Santa Maria, Lisbon Academic Medical Centre, Portugal,17Department of Rheumatology, University Medical Centre Ljubljana, Ljubljana, Slovenia, 18Institute for Musculoskeletal Health, Madrid, Spain,19Karolinska Institutet, Clinical Epidemiology Unit, Department of Medicine Solna, Stockholm, Sweden and 20Division of Rheumatology, University of Geneva, Geneva, Switzerland.



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.


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.


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.


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.


biologic therapies; epidemiology; outcome measures; rheumatoid arthritis; study design

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