Skip to main content
Journal cover image

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

Publication ,  Journal Article
Ringold, S; Hendrickson, A; Abramson, L; Beukelman, T; Blier, PR; Bohnsack, J; Chalom, EC; Gewanter, HL; Gottlieb, B; Hollister, R; Hsu, J ...
Published in: Arthritis Care Res (Hoboken)
April 2015

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.

Duke Scholars

Published In

Arthritis Care Res (Hoboken)

DOI

EISSN

2151-4658

Publication Date

April 2015

Volume

67

Issue

4

Start / End Page

529 / 537

Location

United States

Related Subject Headings

  • Rheumatology
  • Research Design
  • Population Surveillance
  • Physicians
  • Male
  • Longitudinal Studies
  • Infant, Newborn
  • Infant
  • Humans
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Ringold, S., Hendrickson, A., Abramson, L., Beukelman, T., Blier, P. R., Bohnsack, J., … Sobel, R. E. (2015). Novel method to collect medication adverse events in juvenile arthritis: results from the childhood arthritis and rheumatology research alliance enhanced drug safety surveillance project. Arthritis Care Res (Hoboken), 67(4), 529–537. https://doi.org/10.1002/acr.22487
Ringold, Sarah, Audrey Hendrickson, Leslie Abramson, Timothy Beukelman, Peter R. Blier, John Bohnsack, Elizabeth C. Chalom, et al. “Novel method to collect medication adverse events in juvenile arthritis: results from the childhood arthritis and rheumatology research alliance enhanced drug safety surveillance project.Arthritis Care Res (Hoboken) 67, no. 4 (April 2015): 529–37. https://doi.org/10.1002/acr.22487.
Ringold S, Hendrickson A, Abramson L, Beukelman T, Blier PR, Bohnsack J, et al. Novel method to collect medication adverse events in juvenile arthritis: results from the childhood arthritis and rheumatology research alliance enhanced drug safety surveillance project. Arthritis Care Res (Hoboken). 2015 Apr;67(4):529–37.
Ringold, Sarah, et al. “Novel method to collect medication adverse events in juvenile arthritis: results from the childhood arthritis and rheumatology research alliance enhanced drug safety surveillance project.Arthritis Care Res (Hoboken), vol. 67, no. 4, Apr. 2015, pp. 529–37. Pubmed, doi:10.1002/acr.22487.
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. Novel method to collect medication adverse events in juvenile arthritis: results from the childhood arthritis and rheumatology research alliance enhanced drug safety surveillance project. Arthritis Care Res (Hoboken). 2015 Apr;67(4):529–537.
Journal cover image

Published In

Arthritis Care Res (Hoboken)

DOI

EISSN

2151-4658

Publication Date

April 2015

Volume

67

Issue

4

Start / End Page

529 / 537

Location

United States

Related Subject Headings

  • Rheumatology
  • Research Design
  • Population Surveillance
  • Physicians
  • Male
  • Longitudinal Studies
  • Infant, Newborn
  • Infant
  • Humans
  • Female