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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. Ann Rheum Dis, 2010. Coverage & generalisability of the swedish biologics register ARTIS.

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Coverage & generalisability of the swedish biologics register ARTIS

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  1. NeoviusM1, Sundström A1, Simard J1, Jacobsson L3, Geborek P3, Saxne T3, Klareskog L2, Askling J1,2 for the ARTIS Study Group Ann Rheum Dis, 2010 Coverage & generalisability of the swedishbiologics register ARTIS 1Clinical EpidemiologyUnit and 2Rheumatology Unit, Dept of Medicine, Karolinska Institutet 3Dept of Rheumatology, Lund University

  2. Aim To determine coverage and generalisabilityof 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 GroupARD 2010

  3. Methods • Identification of the Swedish RA PopulationRegister linkage of the Swedish RheumatologyQuality Register and the National Patient Register1 • Exposure to BiologicsRegister linkage of the identified RA population with the Swedish Biologics Register ARTIS and the PrescribedDrug Register • IncludedBiologicDrugsPrimaryanalysis: Etanercept and adalimumab, as >99% of the use is captured by the PrescribedDrug RegisterSecondaryanalysis: Includingalsoinfliximab, 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-ModifyingDrugs 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 GroupARD 2010

  5. Methods Exposed patients in ARTIS • GeneralisabilityAssessmentComparison of age, sex and educationlevel in ARTIS-registered vs. non-registered patients Coverage = Exposed patients in the PrescribedDrug Register Neovius, Sundström, Simard, Jacobsson, Geborek, Saxne, Klareskog & Askling for the ARTIS Study GroupARD 2010

  6. Coverage for etanercept and adalimumab Coverage for all biologics Generalisabilityassessment Results

  7. PrimaryAnalysis Etanercept Adalimumab Neovius, Sundström, Simard, Jacobsson, Geborek, Saxne, Klareskog & Askling for the ARTIS Study Group, ARD 2010

  8. SensitivityAnalysis 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 GroupARD 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 generalisabilityregarding demography Neovius, Sundström, Simard, Jacobsson, Geborek, Saxne, Klareskog & Askling for the ARTIS Study GroupARD 2010

  11. RelatedReferences • Neovius M, Simard J, Sundström A, Jacobsson L, Geborek P, Saxne T, Klareskog L & Askling J for the ARTIS Study GroupGeneralisability of Clinical Registers used for DrugSafety and ComparativeEffectiveness Research: Coverage of the Swedish Biologics RegisterAnn 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 JTen years with biologics: For whomdo data on effectiveness and long-termsafetyapply? Rheumatology2010 • Neovius M, Simard J, Askling J for the ARTIS Study GroupNationwide Prevalence of RheumatoidArthritis and Penetration of Disease-ModifyingDrugs in SwedenAnn Rheum Dis 2010 • Askling J, Fored CM, Geborek P, Jacobsson LT, van Vollenhoven R, Feltelius N, Lindblad S & Klareskog LSwedish registers to examinedrugsafety and clinicalissues 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 GroupSmall-area variations in sales of TNF inhibitors in Sweden between 2000 and 2009Scand J Rheumatol 2010

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