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 Todd 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

Research output: Contribution to journalArticle

3 Citations (Scopus)

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

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Juvenile Arthritis
Rheumatology
Arthritis
Safety
Confidence Intervals
Research
Pharmaceutical Preparations
Registries
Poisson Distribution
Physicians
Biological Factors
Clinical Trials

ASJC Scopus subject areas

  • Rheumatology
  • Medicine(all)

Cite this

Novel method to collect medication adverse events in juvenile arthritis : Results from the childhood arthritis and rheumatology research alliance enhanced drug safety surveillance project. / 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 Todd; Klein-Gitelman, 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; Rouster-Stevens, 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.

In: Arthritis Care and Research, Vol. 67, No. 4, 01.04.2015, p. 529-537.

Research output: Contribution to journalArticle

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 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 and Research, vol. 67, no. 4, pp. 529-537. https://doi.org/10.1002/acr.22487
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 Todd ; Klein-Gitelman, 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 ; Rouster-Stevens, 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. / Novel method to collect medication adverse events in juvenile arthritis : Results from the childhood arthritis and rheumatology research alliance enhanced drug safety surveillance project. In: Arthritis Care and Research. 2015 ; Vol. 67, No. 4. pp. 529-537.
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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.",
author = "Sarah Ringold and Audrey Hendrickson and Leslie Abramson and Timothy Beukelman and Blier, {Peter R.} and John Bohnsack and Chalom, {Elizabeth C.} and Gewanter, {Harry L.} and Beth Gottlieb and Roger Hollister and Joyce Hsu and Andrea Hudgins and Ilowite, {Norman Todd} and Marisa Klein-Gitelman and Carol Lindsley and {Lopez Benitez}, {Jorge M.} and Lovell, {Daniel J.} and Tom Mason and Diana Milojevic and Moorthy, {Lakshmi N.} and Kabita Nanda and Karen Onel and Sampath Prahalad and Rabinovich, {C. Egla} and Linda Ray and Kelly Rouster-Stevens and Natasha Ruth and Michael Shishov and Steven Spalding and Reema Syed and Matthew Stoll and Vehe, {Richard K.} and Weiss, {Jennifer E.} and White, {Andrew J.} and Wallace, {Carol A.} and Sobel, {Rachel E.}",
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TY - JOUR

T1 - Novel method to collect medication adverse events in juvenile arthritis

T2 - Results from the childhood arthritis and rheumatology research alliance enhanced drug safety surveillance project

AU - Ringold, Sarah

AU - Hendrickson, Audrey

AU - Abramson, Leslie

AU - Beukelman, Timothy

AU - Blier, Peter R.

AU - Bohnsack, John

AU - Chalom, Elizabeth C.

AU - Gewanter, Harry L.

AU - Gottlieb, Beth

AU - Hollister, Roger

AU - Hsu, Joyce

AU - Hudgins, Andrea

AU - Ilowite, Norman Todd

AU - Klein-Gitelman, Marisa

AU - Lindsley, Carol

AU - Lopez Benitez, Jorge M.

AU - Lovell, Daniel J.

AU - Mason, Tom

AU - Milojevic, Diana

AU - Moorthy, Lakshmi N.

AU - Nanda, Kabita

AU - Onel, Karen

AU - Prahalad, Sampath

AU - Rabinovich, C. Egla

AU - Ray, Linda

AU - Rouster-Stevens, Kelly

AU - Ruth, Natasha

AU - Shishov, Michael

AU - Spalding, Steven

AU - Syed, Reema

AU - Stoll, Matthew

AU - Vehe, Richard K.

AU - Weiss, Jennifer E.

AU - White, Andrew J.

AU - Wallace, Carol A.

AU - Sobel, Rachel E.

PY - 2015/4/1

Y1 - 2015/4/1

N2 - 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.

AB - 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.

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