title: Novel method to collect medication adverse events in juvenile arthritis: results from the childhood arthritis and rheumatology research alliance enhanced drug safety surveillance project.
abstract: OBJECTIVE
  Few data are available regarding the rates of serious adverse events (SAEs) and important medical events (IMEs) outside of product-based registries and clinical trials for juvenile idiopathic arthritis (JIA). The Enhanced Drug Safety Surveillance Project (EDSSP) was developed to pilot a novel system to collect SAEs/IMEs in children with JIA. This analysis reports the results from this 4-year (2008-2012) EDSSP.
  
  
  METHODS
  Participating physicians were surveyed monthly to ascertain whether their JIA patients experienced an SAE or IME. Sites were surveyed every 6 months to determine the number of unique JIA patients seen at each site during that 6-month period. Reporting rates were calculated per 100 person-years and 95% confidence intervals (95% CIs) were calculated based on a Poisson distribution.
  
  
  RESULTS
  Thirty-seven Childhood Arthritis and Rheumatology Research Alliance sites with 115 physicians participated. The mean response rate to the monthly surveys was 65%. There were 147 total SAEs and 145 total IMEs. The largest proportion of SAEs and IMEs occurred in children with polyarticular JIA (39% and 37%, respectively). The majority of SAEs and IMEs were reported for patients receiving therapy with biologic agents (76% and 69%, respectively). The total event rate for SAEs and IMEs combined was 1.07 events per 100 person-years (95% CI 0.95-1.19). The rates for SAEs and IMEs were 0.54 per 100 person-years (95% CI 0.45-0.63) and 0.53 per 100 person-years (95% CI 0.49-0.62), respectively.
  
  
  CONCLUSIONS
  The EDSSP provided a simple tool for SAE/IME reporting within an established research network and resulted in a similar range of reported events as captured by a traditional product-based registry.
authors.affiliation: Seattle Children's Hospital and Research Institute, Seattle, Washington.
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authors.forename: Jennifer E
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mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000639:trends; D018501:Antirheumatic Agents / Q000009:adverse effects*; D001171:Arthritis, Juvenile / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008137:Longitudinal Studies; D008297:Male; D010820:Physicians / Q000639:trends; D011159:Population Surveillance / Q000379:methods*; D012107:Research Design / Q000639:trends; D012219:Rheumatology / Q000379:methods* / Q000639:trends
chemical_list: D018501:Antirheumatic Agents