Study design for a comprehensive assessment of biologic safety using multiple healthcare data systems

Lisa J. Herrinton, Jeffrey R. Curtis, Lang Chen, Liyan Liu, Elizabeth Delzell, James D. Lewis, Daniel H. Solomon, Marie R. Griffin, Rita Ouellet-Hellstom, Timothy Beukelman, Carlos G. Grijalva, Kevin Haynes, Bindee Kuriya, Joyce Lii, Ed Mitchel, Nivedita Patkar, Jeremy Rassen, Kevin L. Winthrop, Parivash Nourjah, Kenneth G. Saag

Research output: Contribution to journalArticlepeer-review

25 Scopus citations


Background: Although biologic treatments have excellent efficacy for many autoimmune diseases, safety concerns persist. Understanding the absolute and comparative risks of adverse events in patient and disease subpopulations is critical for optimal prescribing of biologics. Purpose: The Safety Assessment of Biologic Therapy collaborative was federally funded to provide robust estimates of rates and relative risks of adverse events among biologics users using data from national Medicaid and Medicare plus Medicaid dual-eligible programs, Tennessee Medicaid, Kaiser Permanente, and state pharmaceutical assistance programs supplementing New Jersey and Pennsylvania Medicare programs. This report describes the organizational structure of the collaborative and the study population and methods. Methods: This retrospective cohort study (1998-2007) examined risks of seven classes of adverse events in relation to biologic treatments prescribed for seven autoimmune diseases. Propensity scores were used to control for confounding and enabled pooling of individual-level data across data systems while concealing personal health information. Cox proportional hazard modeling was used to analyze study hypotheses. Results: The cohort was composed of 159000 subjects with rheumatic diseases, 33000 with psoriasis, and 46000 with inflammatory bowel disease. This report summarizes demographic characteristics and drug exposures. Separate reports will provide outcome definitions and estimated hazard ratios for adverse events. Conclusion: This comprehensive research will improve understanding of the safety of these treatments. The methods described may be useful to others planning similar evaluations.

Original languageEnglish (US)
Pages (from-to)1199-1209
Number of pages11
JournalPharmacoepidemiology and Drug Safety
Issue number11
StatePublished - Nov 2011


  • Administrative data
  • Adverse events
  • Ankylosing spondylitis
  • Cohort studies
  • Computerized data
  • Crohn's disease
  • Drug safety
  • Drug toxicity
  • Inflammatory bowel disease
  • Juvenile idiopathic arthritis
  • Medicaid
  • Medicare
  • Pharmacoepidemiology
  • Propensity scores
  • Psoriasis
  • Psoriatic arthritis
  • Rheumatoid arthritis
  • Ulcerative colitis

ASJC Scopus subject areas

  • Epidemiology
  • Pharmacology (medical)


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