EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology

Objectives The introduction of biological therapies for the treatment of rheumatic diseases has drawn attention to the limitations of traditional means of assessing drug safety. Consequently, a series of European academic biologics registers dedicated to this task have been established. Increasing reliance upon safety data generated from observational drug registers makes it important to convert the lessons learned from such registers into recommendations for rheumatologists embarking upon the establishment of future registers, or analysing and reporting from new and existing registers. Methods The Task Force encompassed 11 scientists from European Rheumatology drug registers. Through an informal inventory of critical elements in the establishment of existing rheumatoid arthritis drug registers, of analytical strategies used and of limitations of their results, several ‘points to consider’—beyond established generic guidelines for observational registers/studies but with particular relevance to biologics registers on safety in rheumatology—were assembled. For each ‘point to consider’, contextual and methodological background and examples were compiled. Results A set of seven points to consider was assembled for the establishment of new drug registers with a focus on purpose, population to be targeted, data collection, handling and storage as well as ethical and legal considerations. For analysis and reporting, nine points to consider were assembled (setting, participant, variable, statistical method, descriptive data, outcome data, main results, other analyses and limitations). Conclusions Thoughtful design and planning before the establishment of biologics registers will increase their sustainability, versatility and raw data quality. Harmonisation of analyses and reporting from such registers will improve interpretation of drug safety studies.

[1]  N. Dreyer,et al.  Registries for Evaluating Patient Outcomes: A User’s Guide , 2010 .

[2]  A. Silman,et al.  European biologicals registers: methodology, selected results and perspectives , 2008, Annals of the rheumatic diseases.

[3]  S. Pocock,et al.  Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration , 2007, Annals of Internal Medicine [serial online].

[4]  J. Gómez-Reino,et al.  Risk of tuberculosis in patients treated with tumor necrosis factor antagonists due to incomplete prevention of reactivation of latent infection. , 2007, Arthritis and rheumatism.

[5]  Terry M Therneau,et al.  Primer: demystifying risk—understanding and communicating medical risks , 2007, Nature Clinical Practice Rheumatology.

[6]  L. Jacobsson,et al.  Time-dependent increase in risk of hospitalisation with infection among Swedish RA patients treated with TNF antagonists , 2007, Annals of the rheumatic diseases.

[7]  Matthias Schneider,et al.  Infections in patients with rheumatoid arthritis treated with biologic agents. , 2005, Arthritis and rheumatism.

[8]  M. Sillanpää,et al.  Replication in genetic studies of complex traits , 2004, Annals of human genetics.

[9]  D. Moher,et al.  The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration , 2001, Annals of Internal Medicine.

[10]  S. Schneeweiss,et al.  Causation of Bias: The Episcope , 2001, Epidemiology.

[11]  B. Jönsson,et al.  The burden of rheumatoid arthritis and access to treatment: uptake of new therapies , 2007, The European Journal of Health Economics.

[12]  A. Silman,et al.  The British Society for Rheumatology Biologics Register. Ann Rheum Dis 2005;64 Suppl 4:iv42–3 , 2022 .