May 2007
Volume 48, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2007
Epidemiologic Methods for Detecting Rare, Long-Term Adverse Events Associated With Eye Diseases: The Systemic Immunosuppressive Therapy for Eye Diseases Cohort Study
Author Affiliations & Notes
  • J. H. Kempen
    Ophthalmology/Epidemiology & Biostatistics, Scheie Eye Inst/Univ of Penn, Philadelphia, Pennsylvania
  • C. S. Foster
    Massachusetts Eye Research and Surgery Institute, Cambridge, Massachusetts
  • K. J. Helzlsouer
    Weinberg Center For Women's Health and Medicine, Mercy Medical Center, Baltimore, Maryland
  • D. A. Jabs
    Ophthalmology, Mount Sinai School of Medicine, New York, New York
  • G. A. Levy-Clarke
    Laboratory of Immunology, National Eye Institute, Bethesda, Maryland
  • R. B. Nussenblatt
    Laboratory of Immunology, National Eye Institute, Bethesda, Maryland
  • J. T. Rosenbaum
    Ophthalmology/Rheumatology,
    Oregon Health Sciences University, Portland, Oregon
  • E. B. Suhler
    Ophthalmology,
    Oregon Health Sciences University, Portland, Oregon
  • Systemic Immunosuppressive Therapy for Eye Diseases Cohort Study Group
    Ophthalmology/Epidemiology & Biostatistics, Scheie Eye Inst/Univ of Penn, Philadelphia, Pennsylvania
  • Footnotes
    Commercial Relationships J.H. Kempen, None; C.S. Foster, None; K.J. Helzlsouer, None; D.A. Jabs, None; G.A. Levy-Clarke, None; R.B. Nussenblatt, None; J.T. Rosenbaum, None; E.B. Suhler, None.
  • Footnotes
    Support National Eye Institute Grant EY014943 (Dr. Kempen). Additional support was provided by the Paul and Evanina Mackall Foundation and Research to Prevent Blindness.
Investigative Ophthalmology & Visual Science May 2007, Vol.48, 4408. doi:
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      J. H. Kempen, C. S. Foster, K. J. Helzlsouer, D. A. Jabs, G. A. Levy-Clarke, R. B. Nussenblatt, J. T. Rosenbaum, E. B. Suhler, Systemic Immunosuppressive Therapy for Eye Diseases Cohort Study Group; Epidemiologic Methods for Detecting Rare, Long-Term Adverse Events Associated With Eye Diseases: The Systemic Immunosuppressive Therapy for Eye Diseases Cohort Study. Invest. Ophthalmol. Vis. Sci. 2007;48(13):4408.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose:: To describe epidemiological methods for evaluating putative long-term effects of systemic immunosuppressive therapies on the risk of mortality and cancer, and present the approach of the SITE Cohort Study.

Methods:: Prospective individual-level studies, ideally with randomization, provide the most robust data regarding "effects" of treatments on outcomes, but are very costly and take many years to reach useful conclusions. Retrospective cohort studies, while more efficient in cost and timeliness, are completely dependent on the fortuitous availability of existing records which provide quality information over as much follow-up time as would be required for a prospective study. Case-control methods would require very large sample sizes to study the association of common outcomes (e.g., mortality) and rare exposures (e.g., treatment of eye diseases with immunosuppressive medicines), and incur problems of using surrogate reporting for the (dead) cases but not for controls.

Results:: The SITE Cohort Study is a retrospective cohort study, ascertaining use/non-use of immunosuppressive medications from existing medical records of ~9,263 ocular inflammatory disease patients at five centers. Mortality and cause-specific mortality data are obtained through the National Death Index, a national registry of death certificates, providing ~101,680 person-years of follow-up. United States vital statistics provide general population mortality rates for comparison with treated and non-treated ocular inflammation patients. Calculated (2-tailed) detectable differences in the risk of mortality and of fatal malignancy respectively with respect to the general population for classes of agents are: 22% and 49% for antimetabolites; 28% and 62% for T-cell inhibitors; and 36% and 81% for alkylating agents.

Conclusions:: The SITE Cohort Study is expected to provide valuable information regarding important uncertainties about putative long-term adverse effects of immunosuppressive agents used in managing eye diseases.

Keywords: clinical (human) or epidemiologic studies: biostatistics/epidemiology methodology • clinical (human) or epidemiologic studies: outcomes/complications • uveitis-clinical/animal model 
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