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Risk of serious infections in arthritis patients treated with biological drugs: a matched cohort study and development of prediction model

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

  • Simon Krabbe, c Center for Rheumatology and Spine Diseases , Copenhagen Center for Arthritis Research, Rigshospitalet , Glostrup , Denmark.
  • ,
  • Kathrine L Grøn, c Center for Rheumatology and Spine Diseases , Copenhagen Center for Arthritis Research, Rigshospitalet , Glostrup , Denmark.
  • ,
  • Bente Glintborg, c Center for Rheumatology and Spine Diseases , Copenhagen Center for Arthritis Research, Rigshospitalet , Glostrup , Denmark.
  • ,
  • Mette Nørgaard
  • Frank Mehnert
  • Dorte E Jarbøl, Research Unit for General Practice, Danish Hospital for Rheumatic Diseases, University Hospital of Southern Jutland, Sønderborg, Denmark; Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; Hospital of Southern Jutland, University Hospital of Southern Denmark, Aabenraa, Denmark. Electronic address: Jprimdahl@danskgigthospital.dk.
  • ,
  • Mikkel Østergaard, c Center for Rheumatology and Spine Diseases , Copenhagen Center for Arthritis Research, Rigshospitalet , Glostrup , Denmark.
  • ,
  • Merete L Hetland, c Center for Rheumatology and Spine Diseases , Copenhagen Center for Arthritis Research, Rigshospitalet , Glostrup , Denmark.

OBJECTIVES: Serious infection is a concern for patients with inflammatory joint diseases treated with biological drugs (bDMARDs). The objectives were to compare risk of serious infection, defined as infection leading to hospitalization, in patients initiating bDMARD treatment with the general population and, second, to develop a simple clinical prediction model and to obtain risk estimates for individual patients.

METHODS: Matched-cohort study based on nationwide registries in Denmark. Patients with rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis initiating first bDMARD monitored in the DANBIO registry were matched 1:10 by age, gender and postal code with controls from the general population. The risk of serious infection during 12 months' follow-up was assessed with Cox regression. Prediction models were developed using logistic regression and compared using area under the ROC curve (AUC).

RESULTS: We included 11 372 patients and 113 715 controls. During follow-up, 522 patients (4.6%) and 1,434 controls (1.3%) developed a serious infection (hazard ratio 3.7, 95% confidence interval: 3.4-4.1). Age-stratified risk was largely similar across diagnoses. A simple prediction model, the "DANBIO infection risk score" based on age and a count of six clinical risk factors had moderate discriminative power (internal validation: AUC 0.69), which was comparable to that of the existing RABBIT risk score (external validation: AUC 0.68).

CONCLUSION: Patients with inflammatory joint diseases initiating bDMARD treatment had four times increased risk of serious infection compared with the general population. A simple prediction model, feasible for shared decision-making, was developed to obtain risk estimates for individual patients.

OriginalsprogEngelsk
TidsskriftRheumatology (Oxford, England)
ISSN1462-0324
DOI
StatusE-pub ahead of print - 25 jan. 2021

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