Novel method to collect medication adverse events in juvenile arthritis: results from the childhood arthritis and rheumatology research alliance enhanced drug safety surveillance project.
(Journal Article;Multicenter Study)
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. CONCLUSION: 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.
Ringold, S; Hendrickson, A; Abramson, L; Beukelman, T; Blier, PR; Bohnsack, J; Chalom, EC; Gewanter, HL; Gottlieb, B; Hollister, R; Hsu, J; Hudgins, A; Ilowite, NT; Klein-Gitelman, M; Lindsley, C; Lopez Benitez, JM; Lovell, DJ; Mason, T; Milojevic, D; Moorthy, LN; Nanda, K; Onel, K; Prahalad, S; Rabinovich, CE; Ray, L; Rouster-Stevens, K; Ruth, N; Shishov, M; Spalding, S; Syed, R; Stoll, M; Vehe, RK; Weiss, JE; White, AJ; Wallace, CA; Sobel, RE
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