OBJECTIVE: To develop preliminary criteria for defining disease flare in patients with polyarticular-course juvenile rheumatoid arthritis (JRA). METHODS: Data from a randomized clinical trial of etanercept in JRA (51 patients) and the 6 core response variables (CRV) for JRA were used to derive flare definitions. The criterion standard of flare was treatment with placebo. Candidate flare definitions were assessed by receiver-operator characteristic (ROC) curve properties and other statistics for diagnostic tests. RESULTS: Of the possible flare definitions tested with acceptable statistical properties, the one that seemed to be the most useful was worsening in any 2/6 CRV by > or = 40% without improvement in more than 1 of the remaining CRV by > or = 30%. Two other superior flare definitions were (1) worsening in 3/6 CRV by > or = 30% and (2) any worsening of the Childhood Health Assessment Questionnaire, worsening of erythrocyte sedimentation rate by > or = 30% and worsening of the active joint count by > or = 10%. CONCLUSIONS: CRV are useful for defining flare in JRA. Worsening in any 2/6 CRV by > or = 40% without concomitant improvement of more than one of the remaining CRV by > or = 30% appears to be the most suitable preliminary flare definition. Because the proposed flare criteria were derived from a small number of patients, it is essential to perform more definitive testing of this and several alternative flare definitions in larger patient populations.
RCT Entities:
OBJECTIVE: To develop preliminary criteria for defining disease flare in patients with polyarticular-course juvenile rheumatoid arthritis (JRA). METHODS: Data from a randomized clinical trial of etanercept in JRA (51 patients) and the 6 core response variables (CRV) for JRA were used to derive flare definitions. The criterion standard of flare was treatment with placebo. Candidate flare definitions were assessed by receiver-operator characteristic (ROC) curve properties and other statistics for diagnostic tests. RESULTS: Of the possible flare definitions tested with acceptable statistical properties, the one that seemed to be the most useful was worsening in any 2/6 CRV by > or = 40% without improvement in more than 1 of the remaining CRV by > or = 30%. Two other superior flare definitions were (1) worsening in 3/6 CRV by > or = 30% and (2) any worsening of the Childhood Health Assessment Questionnaire, worsening of erythrocyte sedimentation rate by > or = 30% and worsening of the active joint count by > or = 10%. CONCLUSIONS: CRV are useful for defining flare in JRA. Worsening in any 2/6 CRV by > or = 40% without concomitant improvement of more than one of the remaining CRV by > or = 30% appears to be the most suitable preliminary flare definition. Because the proposed flare criteria were derived from a small number of patients, it is essential to perform more definitive testing of this and several alternative flare definitions in larger patient populations.
Authors: Femke H M Prince; Marinka Twilt; Nelleke C J A Jansen-Wijngaarden; Lisette W A van Suijlekom-Smit Journal: Ann Rheum Dis Date: 2007-02-26 Impact factor: 19.103
Authors: Chelsey J F Smith; Frauke Förger; Gretchen Bandoli; Christina D Chambers Journal: Arthritis Care Res (Hoboken) Date: 2019-07-04 Impact factor: 4.794
Authors: Marloes W Heijstek; Gecilmara C S Pileggi; Evelien Zonneveld-Huijssoon; Wineke Armbrust; Esther P A H Hoppenreijs; Cuno S P M Uiterwaal; Wietse Kuis; Nico M Wulffraat Journal: Ann Rheum Dis Date: 2007-02-06 Impact factor: 19.103
Authors: Daniel J Lovell; Anne L Johnson; Bin Huang; Beth S Gottlieb; Paula W Morris; Yukiko Kimura; Karen Onel; Suzanne C Li; Alexei A Grom; Janalee Taylor; Hermine I Brunner; Jennifer L Huggins; James J Nocton; Kathleen A Haines; Barbara S Edelheit; Michael Shishov; Lawrence K Jung; Calvin B Williams; Melissa S Tesher; Denise M Costanzo; Lawrence S Zemel; Jason A Dare; Murray H Passo; Kaleo C Ede; Judyann C Olson; Elaine A Cassidy; Thomas A Griffin; Linda Wagner-Weiner; Jennifer E Weiss; Larry B Vogler; Kelly A Rouster-Stevens; Timothy Beukelman; Randy Q Cron; Daniel Kietz; Kenneth Schikler; Kara M Schmidt; Jay Mehta; Dawn M Wahezi; Tracy V Ting; James W Verbsky; B Anne Eberhard; Steven Spalding; Chen Chen; Edward H Giannini Journal: Arthritis Rheumatol Date: 2018-07-25 Impact factor: 10.995