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Non-viral opportunistic infections in new users of tumour necrosis factor inhibitor therapy: results of the SAfety Assessment of Biologic ThERapy (SABER) Study
  1. John W Baddley1,2,
  2. Kevin L Winthrop3,
  3. Lang Chen1,
  4. Liyan Liu4,
  5. Carlos G Grijalva5,
  6. Elizabeth Delzell1,
  7. Timothy Beukelman1,
  8. Nivedita M Patkar1,
  9. Fenglong Xie1,
  10. Kenneth G Saag1,
  11. Lisa J Herrinton4,
  12. Daniel H Solomon6,
  13. James D Lewis7,
  14. Jeffrey R Curtis1
  1. 1Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, USA
  2. 2Medical Service, Birmingham VA Medical Center, Birmingham, Alabama, USA
  3. 3Department of Medicine, Oregon Health and Science University, Portland, Oregon, USA
  4. 4Division of Research, Kaiser Permanente Northern California, Oakland, California, USA
  5. 5Department of Medicine, Vanderbilt University, Nashville, Tennessee, USA
  6. 6Department of Medicine, Boston, Brigham and Women's Hospital-Harvard University, Boston, Massachusetts, USA
  7. 7Center for Clinical Epidemiology and Biostatistics, Perlman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA
  1. Correspondence to Dr John W Baddley, Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, 1900 University Boulevard, 229 Tinsley Harrison Tower, Birmingham, AL 35294-0006, USA; jbaddley{at}


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 non-biological disease-modifying antirheumatic drugs (DMARD) overall and within each disease cohort. Cox regression models were used to compare propensity-score 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.

  • DMARDs (biologic)
  • Tuberculosis
  • Infections
  • Rheumatoid Arthritis
  • TNF-alpha

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