Coverage & generalisability of the swedish biologics register ARTIS

Ann Rheum Dis, 2010

COVERAGE & GENERALISABILITY OF THE SWEDISH BIOLOGICS REGISTER ARTIS

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

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 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

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

Coverage = Exposed patients in ARTIS Exposed patients in the Prescribed Drug Register

Generalisability Assessment

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

1.

2.

3.

Coverage for etanercept and adalimumab Coverage for all biologics Generalisability assessment

RESULTS

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

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

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