EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology.
OBJECTIVE
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.
Arthritis Research UK Epidemiology Unit, The University of Manchester, Oxford Road, Manchester, UK. will.dixon@manchester.ac.uk
William G
WG
Dixon
Loreto
L
Carmona
Axel
A
Finckh
Merete Lund
ML
Hetland
Tore K
TK
Kvien
Robert
R
Landewe
Joachim
J
Listing
Paulo J
PJ
Nicola
Ulrik
U
Tarp
Angela
A
Zink
Johan
J
Askling
D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001688:Biological Products / Q000009:adverse effects* / Q000627:therapeutic use; D004812:Epidemiologic Methods; D005060:Europe; D006801:Humans; D018579:Patient Selection; D012042:Registries / Q000592:standards*; D012216:Rheumatic Diseases / Q000188:drug therapy*; D016896:Treatment Outcome
D018501:Antirheumatic Agents; D001688:Biological Products