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Novel Method to Collect Medication Adverse Events in Juvenile Arthritis: Results From the Childhood Arthritis and Rheumatology Research Alliance Enhanced Drug Safety Surveillance Project
Author(s) -
Ringold Sarah,
Hendrickson Audrey,
Abramson Leslie,
Beukelman Timothy,
Blier Peter R.,
Bohnsack John,
Chalom Elizabeth C.,
Gewanter Harry L.,
Gottlieb Beth,
Hollister Roger,
Hsu Joyce,
Hudgins Andrea,
Ilowite Norman T.,
KleinGitelman Marisa,
Lindsley Carol,
Lopez Benitez Jorge M.,
Lovell Daniel J.,
Mason Tom,
Milojevic Diana,
Moorthy Lakshmi N.,
Nanda Kabita,
Onel Karen,
Prahalad Sampath,
Rabinovich C. Egla,
Ray Linda,
RousterStevens Kelly,
Ruth Natasha,
Shishov Michael,
Spalding Steven,
Syed Reema,
Stoll Matthew,
Vehe Richard K.,
Weiss Jennifer E.,
White Andrew J.,
Wallace Carol A.,
Sobel Rachel E.
Publication year - 2015
Publication title -
arthritis care and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.032
H-Index - 163
eISSN - 2151-4658
pISSN - 2151-464X
DOI - 10.1002/acr.22487
Subject(s) - medicine , adverse effect , imes , confidence interval , rheumatology , arthritis , pediatrics , biochemistry , chemistry , carbene , catalysis
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.