1079. Risk of Non-mycobacterial Opportunistic Infections in New Users of TNF Inhibitor Therapy: Results of the SAfety of Biologic ThERapy (SABER) Study
Session: Poster Abstract Session: Infection in Immunocompromised Patients
Saturday, October 22, 2011
Room: Poster Hall B1
  • IDSA_Pres_1079_Baddley_SABER.pdf (230.2 kB)
  • Background: Newer biologic therapies such as TNF-alpha inhibitors represent important treatment advances for inflammatory and autoimmune diseases; however, risk of opportunistic infections (OIs) other than mycobacterial disease has been poorly characterized.  

    Methods:   We identified new users of anti-TNF therapy from a cohort of patients with rheumatoid arthritis (RA), inflammatory bowel disease (IBD), psoriasis (PsO), psoriatic arthritis (PsA),  and ankylosing spondylitis (AS) from 2000-2007 from Kaiser Permanente Northern California, Pharmaceutical Assistance Contract for the Elderly, Tennessee Medicaid and national Medicaid/Medicare.  Cases of non-mycobacterial OIs were identified by use of ICD-9 codes and OI rates were estimated among initiators of TNF-alpha inhibitors and initiators of methotrexate or other non-biologic immunosuppressive agents (e.g. azathioprine, sulfasalazine).  Follow-up was truncated at exposure discontinuation, death, study end or OI, whichever came first. The rate of OIs was compared between anti-TNF users and non-biologic comparator drugs in disease specific cohorts. Confounding was controlled through adjustment for the quintile of the propensity score and steroid use with Cox proportional hazards models.

    Results:  We identified 47235 new episodes of anti-TNF use among patients with inflammatory diseases.  Among RA patients, the crude rate of non-mycobacterial, non-zoster OIs in new anti-TNF users was 236 per 100,000 person-years (adjusted hazard ratio 1.47; 95% CI: 0.73-3.3).  Lower rates were seen in new anti-TNF users with PsO, PsA and AS (pooled rate, 121 per 100,000) and IBD (rate, 172 per 100,000).  The crude rate of zoster in new anti-TNF users with RA was 541 per 100,000 person-years (adjusted hazard ratio 1.16; 95% CI: 0.77-1.8) and lower in patients with PsO, PsA and AS (pooled rate, 145 per 100,000) and IBD (rate, 129 per 100,000).

    Conclusion: In a cohort of US patients with inflammatory diseases, overall rates for non-mycobacterial OIs are low and not significantly higher in new users of TNF drugs when compared to non-biologic comparators.  Among new anti-TNF users, OI rates were lowest in patients with non-RA inflammatory diseases. 


    Subject Category: N. Hospital-acquired and surgical infections, infection control, and health outcomes including general public health and health services research

    John Baddley, MD, MSPH1,2, Kevin Winthrop, MD, MPH3, Carlos Grijalva, MD MPH4, Lang Chen, PhD5, Fenglong Xie5, Elizabeth Delzell, PhD5, Tim Beukelman, MD5, Parivash Nourjah6, Rita Ouellet-Hellstrom7, Nivedita Patkar8, Kenneth Saag, MD5 and Jeffrey Curtis, MD5, (1)Birmingham Veterans Affairs Medical Center, Birmingham, AL, (2)Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, (3)Oregon Health and Sciences University, Portland, OR, (4)Vanderbilt University School of Medicine, Nashville, TN, (5)University of Alabama at Birmingham, Birmingham, AL, (6)AHRQ Center for Outcomes and Evidence, Bethesda, MD, (7)FDA/CDER, Silver Spring, MD, (8)Medicine, University of Alabama at Birmingham, Birmingham, AL


    J. Baddley, Pfizer: Consultant and Grant Investigator, Consulting fee
    Merck: Scientific Advisor, Consulting fee
    Abbott: Scientific Advisor, Consulting fee

    K. Winthrop, Genentech: Consultant, Consulting fee
    Abbott: Consultant, Consulting fee
    Amgen: Consultant, Consulting fee
    Oxford Immunotech: Consultant, Consulting fee

    C. Grijalva, None

    L. Chen, None

    F. Xie, None

    E. Delzell, None

    T. Beukelman, None

    P. Nourjah, None

    R. Ouellet-Hellstrom, None

    N. Patkar, None

    K. Saag, Merck: Consultant and Research Contractor, Consulting fee and Research grant
    Lilly: Consultant and Research Contractor, Consulting fee and Research grant
    Novartis: Consultant and Research Contractor, Consulting fee and Research grant
    Amgen: Consultant and Research Contractor, Consulting fee and Research grant

    J. Curtis, None

    Findings in the abstracts are embargoed until 12:01 a.m. EST Thursday, Oct. 20 with the exception of research findings presented at IDSA press conferences.