Browsing by Author "Ferriani, Virginia"

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    Methotrexate withdrawal at 6 vs 12 months in juvenile idiopathic arthritis in remission a randomized clinical trial
    (2010-04-07) Foell, Dirk; Wulffraat, Nico; Wedderburn, Lucy R.; Wittkowski, Helmut; Frosch, Michael; Gerß, Joachim; Stanevicha, Valda; Mihaylova, Dimitrina; Ferriani, Virginia; Tsakalidou, Florence Kanakoudi; Foeldvari, Ivan; Cuttica, Ruben; Gonzalez, Benito; Ravelli, Angelo; Khubchandani, Raju; Oliveira, Sheila; Armbrust, Wineke; Garay, Stella; Vojinovic, Jelena; Norambuena, Ximena; Gamir, María Luz; García-Consuegra, Julia; Lepore, Loredana; Susic, Gordana; Corona, Fabrizia; Dolezalova, Pavla; Pistorio, Angela; Martini, Alberto; Ruperto, Nicolino; Roth, Johannes; Rīga Stradiņš University
    Context Novel therapies have improved the remission rate in chronic inflammatory disorders including juvenile idiopathic arthritis (JIA). Therefore, strategies of tapering therapy and reliable parameters for detecting subclinical inflammation have now become challenging questions. Objectives To analyze whether longer methotrexate treatment during remission of JIA prevents flares after withdrawal of medication and whether specific biomarkers identify patients at risk for flares. Design, Setting, and Patients Prospective, open, multicenter, medicationwithdrawal randomized clinical trial including 364 patients (median age, 11.0 years) with JIA recruited in 61 centers from 29 countries between February 2005 and June 2006. Patients were included at first confirmation of clinical remission while continuing medication. At the time of therapy withdrawal, levels of the phagocyte activation marker myeloidrelated proteins 8 and 14 heterocomplex (MRP8/14) were determined. Intervention Patients were randomly assigned to continue with methotrexate therapy for either 6 months (group 1 [n=183]) or 12 months (group 2 [n=181]) after induction of disease remission. Main Outcome Measures Primary outcome was relapse rate in the 2 treatment groups; secondary outcome was time to relapse. In a prespecified cohort analysis, the prognostic accuracy of MRP8/14 concentrations for the risk of flares was assessed. Results Intention-to-treat analysis of the primary outcome revealed relapse within 24 months after the inclusion into the study in 98 of 183 patients (relapse rate, 56.7%) in group 1 and 94 of 181 (55.6%) in group 2. The odds ratio for group 1 vs group 2 was 1.02 (95% CI, 0.82-1.27; P=.86). The median relapse-free interval after inclusion was 21.0 months in group 1 and 23.0 months in group 2. The hazard ratio for group 1 vs group 2 was 1.07 (95% CI, 0.82-1.41; P=.61). Median follow-up duration after inclusion was 34.2 and 34.3 months in groups 1 and 2, respectively. Levels of MRP8/14 during remission were significantly higher in patients who subsequently developed flares (median, 715 [IQR, 320-1110] ng/mL) compared with patients maintaining stable remission (400 [IQR, 220-800] ng/mL; P=.003). Low MRP8/14 levels indicated a low risk of flares within the next 3 months following the biomarker test (area under the receiver operating characteristic curve, 0.76; 95% CI, 0.62-0.90). Conclusions In patients with JIA in remission, a 12-month vs 6-month withdrawal of methotrexate did not reduce the relapse rate. Higher MRP8/14 concentrations were associated with risk of relapse after discontinuing methotrexate. Trial Registration isrctn.org Identifier: ISRCTN18186313.
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    The Provisional Paediatric Rheumatology International Trials Organisation/American College of Rheumatology/European League Against Rheumatism disease activity core set for the evaluation of response to therapy in juvenile dermatomyositis : A prospective validation study
    (2008-01-15) Ruperto, Nicolino; Ravelli, Angelo; Pistorio, Angela; Ferriani, Virginia; Calvo, Immaculada; Ganser, Gerd; Brunner, Jurgen; Dannecker, Guenther; Silva, Clovis Arthur; Stanevicha, Valda; Ten Cate, Rebecca; Van Suijlekom-Smit, Lisette W.A.; Voygioyka, Olga; Fischbach, Michel; Foeldvari, Ivan; Hilario, Odete; Modesto, Consuelo; Saurenmann, Rotraud K.; Sauvain, Marie Josephe; Scheibel, Iloite; Sommelet, Danièle; Tambic-Bukovac, Lana; Barcellona, Roberto; Brik, Riva; Ehl, Stephan; Jovanovic, Mirjana; Rovensky, Jozef; Bagnasco, Francesca; Lovell, Daniel J.; Martini, Alberto; Rīga Stradiņš University
    Objective. To validate a core set of outcome measures for the evaluation of response to treatment in patients with juvenile dermatomyositis (DM). Methods. In 2001, a preliminary consensus-derived core set for evaluating response to therapy in juvenile DM was established. In the present study, the core set was validated through an evidence-based, large-scale data collection that led to the enrollment of 294 patients from 36 countries. Consecutive patients with active disease were assessed at baseline and after 6 months. The validation procedures included assessment of feasibility, responsiveness, discriminant and construct ability, concordance in the evaluation of response to therapy between physicians and parents, redundancy, internal consistency, and ability to predict a therapeutic response. Results. The following clinical measures were found to be feasible, and to have good construct validity, discriminative ability, and internal consistency; furthermore, they were not redundant, proved responsive to clinically important changes in disease activity, and were associated strongly with treatment outcome and thus were included in the final core set: 1) physician's global assessment of disease activity, 2) muscle strength, 3) global disease activity measure, 4) parent's global assessment of patient's well-being, 5) functional ability, and 6) health-related quality of life. Conclusion. The members of the Paediatric Rheumatology International Trials Organisation, with the endorsement of the American College of Rheumatology and the European League Against Rheumatism, propose a core set of criteria for the evaluation of response to therapy that is scientifically and clinically relevant and statistically validated. The core set will help standardize the conduct and reporting of clinical trials and assist practitioners in deciding whether a child with juvenile DM has responded adequately to therapy.