Coverage & generalisability of the swedish biologics register ARTIS

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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

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

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

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

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

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

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

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

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

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

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):707-12. 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