1. Coverage & generalisability of the swedish biologics register ARTIS
Ann Rheum Dis, 2010
Coverage & generalisability of the swedish biologics register ARTIS
Neovius M1, Sundström A1, Simard J1, Jacobsson L3, Geborek P3, Saxne T3, Klareskog L2, Askling J1,2 for the ARTIS Study Group
1Clinical Epidemiology Unit and 2Rheumatology Unit, Dept of Medicine, Karolinska Institutet
3Dept of Rheumatology, Lund University

2. Aim
To determine coverage and generalisability of data in the Swedish Biologics Register ARTIS for patients with RA exposed to biologics
Neovius, Sundström, Simard, Jacobsson, Geborek, Saxne, Klareskog & Askling for the ARTIS Study Group ARD 2010

3. Methods
Identification of the Swedish RA Population Register linkage of the Swedish Rheumatology Quality Register and the National Patient Register1
Exposure to Biologics Register linkage of the identified RA population with the Swedish Biologics Register ARTIS and the Prescribed Drug Register
Included Biologic Drugs Primary analysis: Etanercept and adalimumab, as >99% of the use is captured by the Prescribed Drug Register Secondary analysis: Including also infliximab, abatacept, anakinra and rituximab
1For details, see separate publication: Neovius, Simard & Askling for the ARTIS Study Group, Nationwide Prevalence of RA and Penetration of Disease-Modifying Drugs in Sweden, ARD 2010

4. Methods
Venn-diagram illustrating the overlap in number of patients identified from each source (total n=62,897)
Neovius, Sundström, Simard, Jacobsson, Geborek, Saxne, Klareskog & Askling for the ARTIS Study Group ARD 2010

5. Methods
Exposed patients in ARTIS
Generalisability Assessment Comparison of age, sex and education level in ARTIS-registered vs. non-registered patients
Coverage =
Exposed patients in the Prescribed Drug Register
Neovius, Sundström, Simard, Jacobsson, Geborek, Saxne, Klareskog & Askling for the ARTIS Study Group ARD 2010

6. Results Coverage for etanercept and adalimumab
Coverage for all biologics
Generalisability assessment
Results

7. Primary Analysis Etanercept Adalimumab
Den andra faktorn som påverkar tillförlitligheten är länsvisa variationer i täckningsgrad – det finns det.
Den här bilden visar ARTIS-registrets täckning för enbrel och humira. För att vara ett ickekirurgiskt/slutenvårdsbaserat register är 87% täckningsgrad mycket bra. Och den länsvisa variationen är liten. Dock finns det en rejäl uteliggare i form av Västernorrland.
Täckningsgrad vs generaliserbarhet
Neovius, Sundström, Simard, Jacobsson, Geborek, Saxne, Klareskog & Askling for the ARTIS Study Group, ARD 2010

8. Sensitivity Analysis Etanercept Adalimumab Infliximab Abatacept
Rituximab
Anakinra
Neovius, Sundström, Simard, Jacobsson, Geborek, Saxne, Klareskog & Askling for the ARTIS Study Group, ARD 2010

9. Generalisability
In multivariable analysis, ARTIS-registered and non-registered patients did not differ by age (p=0.19), sex (p=0.18) or education level (p=0.32)
Neovius, Sundström, Simard, Jacobsson, Geborek, Saxne, Klareskog & Askling for the ARTIS Study Group ARD 2010

10. Conclusion
Nationwide drug and demographic data may function as quality metrics for coverage & generalisability assessments
Using such data, the coverage of ARTIS was estimated at 87-92%, with no indications of compromised generalisability regarding demography
Neovius, Sundström, Simard, Jacobsson, Geborek, Saxne, Klareskog & Askling for the ARTIS Study Group ARD 2010

11. Related References
Neovius M, Simard J, Sundström A, Jacobsson L, Geborek P, Saxne T, Klareskog L & Askling J for the ARTIS Study Group Generalisability of Clinical Registers used for Drug Safety and Comparative Effectiveness Research: Coverage of the Swedish Biologics Register Ann Rheum Dis 2010
Simard J, Arkema E, Sundström A, Geborek P, Saxne T, Baecklund E, Coster L, Dackhammar C, Jacobsson L, Feltelius N, Lindblad S, Rantapää-Dahlqvist S, Klareskog L, Van Vollenhoven RF, Neovius M & Askling J Ten years with biologics: For whom do data on effectiveness and long-term safety apply? Rheumatology 2010
Neovius M, Simard J, Askling J for the ARTIS Study Group Nationwide Prevalence of Rheumatoid Arthritis and Penetration of Disease-Modifying Drugs in Sweden Ann Rheum Dis 2010
Askling J, Fored CM, Geborek P, Jacobsson LT, van Vollenhoven R, Feltelius N, Lindblad S & Klareskog L Swedish registers to examine drug safety and clinical issues in RA. Ann Rheum Dis 2006;65(6):
Neovius M, Sundstrom A, Simard J, Wettermark B, Cars T, Feltelius N, Askling J & Klareskog L for the ARTIS Study Group Small-area variations in sales of TNF inhibitors in Sweden between 2000 and 2009 Scand J Rheumatol 2010