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Generalisability of clinical registers used for drug safety and comparative effectiveness research: coverage of the Swedish Biologics Register
  1. M Neovius1,
  2. JF Simard1,
  3. A Sundström1,
  4. L Jacobsson2,
  5. P Geborek2,
  6. T Saxne2,
  7. N Feltelius3,
  8. L Klareskog4,
  9. J Askling1,4,
  10. for the ARTIS Study Group
  1. 1Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden
  2. 2Department of Rheumatology, Lund University, Lund, Sweden
  3. 3Medical Products Agency, Uppsala, Sweden
  4. 4Rheumatology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden
  1. Correspondence to Martin Neovius, Clinical Epidemiology Unit (T2), Department of Medicine, Karolinska Institutet, SE-171 76 Stockholm, Sweden; martin.neovius{at}


Objective To determine coverage and generalisability of data in the Swedish Biologics Register ARTIS.

Methods Patients with adult onset rheumatoid arthritis (RA) were identified in the National Patient Register and the Swedish Rheumatology Quality Register, including the ARTIS cohort of patients exposed to biological agents. Exposure to etanercept and adalimumab between 2006 and 2008 was determined by register linkage to the Prescribed Drug Register which contains patient-level data on >99% of all etanercept and adalimumab use in Sweden.

Results Of 62 897 patients with RA, 6510 had received treatment with etanercept or adalimumab according to the Prescribed Drug Register. Of these, 5673 were also registered in ARTIS, resulting in a national coverage of 87%. The regional variation was small with >85% coverage in 18 of 21 counties. In multivariable analysis, ARTIS-registered and non-registered patients did not differ by age (p=0.62), sex (p=0.84) or education level (p=0.24).

Conclusion Nationwide drug dispensing and demographic data may function as quality metrics for coverage and generalisability assessments. Using such data, the coverage of ARTIS was estimated at 87% with no indications of compromised external generalisability regarding demography.

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  • Competing interests The ARTIS Study Group conducts scientific analyses using data from the Swedish Biologics Register ARTIS run by the Swedish Society for Rheumatology. For the maintenance of this register, the Swedish Society for Rheumatology has received funding independent of the conduct of these scientific analyses, from Schering-Plough, BMS, Wyeth, Abbott Laboratories and Roche.

  • Ethics approval Ethical approval was granted by the regional ethics committee, Karolinska Institutet, Sweden.

  • Provenance and peer review Commissioned; externally peer-reviewed.