Non-viral opportunistic infections in new users of tumour necrosis factor inhibitor therapy: Results of the SAfety assessment of biologic ThERapy (SABER) study

John W. Baddley, Kevin L. Winthrop, Lang Chen, Liyan Liu, Carlos G. Grijalva, Elizabeth Delzell, Timothy Beukelman, Nivedita M. Patkar, Fenglong Xie, Kenneth G. Saag, Lisa J. Herrinton, Daniel H. Solomon, James D. Lewis, Jeffrey R. Curtis

Research output: Contribution to journalArticlepeer-review

62 Scopus citations

Abstract

Objectives To determine among patients with autoimmune diseases in the USA whether the risk of non-viral opportunistic infections (OI) was increased among new users of tumour necrosis factor α inhibitors (TNFI), when compared to users of non-biological agents used for active disease.

Methods We identified new users of TNFI among cohorts of rheumatoid arthritis (RA), inflammatory bowel disease and psoriasis-psoriatic arthritis-ankylosing spondylitis patients during 1998-2007 using combined data from Kaiser Permanente Northern California, two pharmaceutical assistance programmes for the elderly, Tennessee Medicaid and US Medicaid/Medicare programmes. We compared incidence of non-viral OI among new TNFI users and patients initiating nonbiological disease-modifying antirheumatic drugs (DMARD) overall and within each disease cohort. Cox regression models were used to compare propensityscore and steroid-adjusted OI incidence between new TNFI and non-biological DMARD users.

Results Within a cohort of 33 324 new TNFI users we identified 80 non-viral OI, the most common of which was pneumocystosis (n=16). In the combined cohort, crude rates of non-viral OI among new users of TNFI compared to those initiating non-biological DMARD was 2.7 versus 1.7 per 1000-person-years (aHR 1.6, 95% CI 1.0 to 2.6). Baseline corticosteroid use was associated with non-viral OI (aHR 2.5, 95% CI 1.5 to 4.0). In the RA cohort, rates of non-viral OI among new users of infliximab were higher when compared to patients newly starting non-biological DMARD (aHR 2.6, 95% CI 1.2 to 5.6) or new etanercept users (aHR 2.9, 95% CI 1.5 to 5.4).

Conclusions In the USA, the rate of non-viral OI was higher among new users of TNFI with autoimmune diseases compared to non-biological DMARD users.

Original languageEnglish (US)
Pages (from-to)1942-1948
Number of pages7
JournalAnnals of the rheumatic diseases
Volume73
Issue number11
DOIs
StatePublished - Nov 1 2014

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)

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