What is it about?
Whilst biological therapies have significantly improved outcomes for patients with rheumatoid arthritis (RA), rare adverse events remain a concern. Many European countries have set up national registers to evaluate long-term outcomes. However, despite large patient numbers in these registers, it is likely that individually they lack power to confidently rule out moderate yet clinically meaningful increases in risks of rare potential adverse events, such as lymphoma. Under the auspices of EULAR, a study group of investigators representing European biologic registers was convened to explore the feasibility of combined analyses. The aim of this initial assessment was to collect and compare patient characteristics starting first biologic across Europe and compare information on the various data items collected within these registers. A total of 5320 patients starting their first biologic treatment were included. Mean age at the start of therapy was in the mid-50s in all studies with proportionally more female participants. All registers` collected data on age, gender, disease duration, rheumatoid factor status and disease activity score. The disease activity score was worst in Slovenia and best in Switzerland. The health assessment score was worst in the UK and best in Norway and Switzerland. Current smoking ranged from 9% (Portugal) to 34% (Switzerland). Nine registers collecting information on co-morbidities.
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Why is it important?
This study showed a successful European-wide collaboration across rheumatology biologic registers, and also identified differences in which therapies are prescribed, recruitment strategies and data items collected. These differences need to be considered when comparing results from different studies, or combined results. The lack of a common dataset across Europe calls for further work to harmonize data collection across registers.
Perspectives
This was my first experience in working with other European rheumatoid arthritis registers and observational drug studies. I really enjoyed getting to know the other teams around Europe and collating information about all of our studies. It was also my first publication for the BSRBR-RA and has been presented at one national and one international conference.
Dr. Lianne Kearsley-Fleet
University of Manchester
Read the Original
This page is a summary of: 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, Rheumatology, November 2014, Oxford University Press (OUP),
DOI: 10.1093/rheumatology/keu446.
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