Ann Rheum Dis, 2010
Neovius M 1 , Sundström A 1 , Simard J 1 , Jacobsson L 3 , Geborek P 3 , Saxne T 3 ,
Klareskog L 2 , Askling J 1,2 for the ARTIS Study Group
1 Clinical Epidemiology Unit and 2 Rheumatology Unit, Dept of Medicine, Karolinska Institutet
3 Dept of Rheumatology, Lund University

Neovius, Sundström, Simard, Jacobsson, Geborek,
Saxne, Klareskog & Askling for the ARTIS Study Group
ARD 2010

• Identification of the Swedish RA Population
Register linkage of the Swedish Rheumatology Quality Register and the National Patient Register 1
• 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
1 For 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

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

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

1.
Coverage for etanercept and adalimumab
2.
Coverage for all biologics
3.
Generalisability assessment

Primary Analysis
Etanercept
Adalimumab
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

In multivariable analysis, ARTIS-registered and nonregistered 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

• 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

1.
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
2.
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
3.
4.
5.
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