Novel method to collect medication adverse events in juvenile arthritis: Results from the childhood arthritis and rheumatology research alliance enhanced drug safety surveillance project

Sarah Ringold*, Audrey Hendrickson, Leslie Abramson, Timothy Beukelman, Peter R. Blier, John Bohnsack, Elizabeth C. Chalom, Harry L. Gewanter, Beth Gottlieb, Roger Hollister, Joyce Hsu, Andrea Hudgins, Norman T. Ilowite, Marisa Klein-Gitelman, Carol Lindsley, Jorge M. Lopez Benitez, Daniel J. Lovell, Tom Mason, Diana Milojevic, Lakshmi N. MoorthyKabita Nanda, Karen Onel, Sampath Prahalad, C. Egla Rabinovich, Linda Ray, Kelly Rouster-Stevens, Natasha Ruth, Michael Shishov, Steven Spalding, Reema Syed, Matthew Stoll, Richard K. Vehe, Jennifer E. Weiss, Andrew J. White, Carol A. Wallace, Rachel E. Sobel

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

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. 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.

Original languageEnglish (US)
Pages (from-to)529-537
Number of pages9
JournalArthritis Care and Research
Volume67
Issue number4
DOIs
StatePublished - Apr 1 2015

ASJC Scopus subject areas

  • Rheumatology

Fingerprint

Dive into the research topics of 'Novel method to collect medication adverse events in juvenile arthritis: Results from the childhood arthritis and rheumatology research alliance enhanced drug safety surveillance project'. Together they form a unique fingerprint.

Cite this