%0 Journal Article %J Arthritis Care Res (Hoboken) %D 2010 %T Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis. %A Ruperto, Nicolino %A Lovell, Daniel J %A Li, Tracy %A Sztajnbok, Flavio %A Goldenstein-Schainberg, Claudia %A Scheinberg, Morton %A Penades, Inmaculada Calvo %A Fischbach, Michael %A Alcala, Javier Orozco %A Hashkes, Philip J %A Hom, Christine %A Jung, Lawrence %A Lepore, Loredana %A Oliveira, Sheila %A Wallace, Carol %A Alessio, Maria %A Quartier, Pierre %A Cortis, Elisabetta %A Eberhard, Anne %A Simonini, Gabriele %A Lemelle, Irene %A Chalom, Elizabeth Candell %A Sigal, Leonard H %A Block, Alan %A Covucci, Allison %A Nys, Marleen %A Martini, Alberto %A Giannini, Edward H %K Adolescent %K Arthritis, Juvenile %K Child %K Double-Blind Method %K Female %K Health Status %K Humans %K Immunoconjugates %K Male %K Pain %K Quality of Life %K Questionnaires %K Sleep Stages %X

OBJECTIVE: To assess health-related quality of life (HRQOL) in abatacept-treated children/adolescents with juvenile idiopathic arthritis (JIA).

METHODS: In this phase III, double-blind, placebo-controlled trial, subjects with active polyarticular course JIA and an inadequate response/intolerance to ≥1 disease-modifying antirheumatic drug (including biologics) received abatacept 10 mg/kg plus methotrexate (MTX) during the 4-month open-label period (period A). Subjects achieving the American College of Rheumatology Pediatric 30 criteria for improvement (defined "responders") were randomized to abatacept or placebo (plus MTX) in the 6-month double-blind withdrawal period (period B). HRQOL assessments included 15 Child Health Questionnaire (CHQ) health concepts plus the physical (PhS) and psychosocial summary scores (PsS), pain (100-mm visual analog scale), the Children's Sleep Habits Questionnaire, and a daily activity participation questionnaire.

RESULTS: A total of 190 subjects from period A and 122 from period B were eligible for analysis. In period A, there were substantial improvements across all of the CHQ domains (greatest improvement was in pain/discomfort) and the PhS (8.3 units) and PsS (4.3 units) with abatacept. At the end of period B, abatacept-treated subjects had greater improvements versus placebo in all domains (except behavior) and both summary scores. Similar improvement patterns were seen with pain and sleep. For participation in daily activities, an additional 2.6 school days/month and 2.3 parents' usual activity days/month were gained in period A responders with abatacept, and further gains were made in period B (1.9 versus 0.9 [P = 0.033] and 0.2 versus -1.3 [P = 0.109] school days/month and parents' usual activity days/month, respectively, in abatacept- versus placebo-treated subjects).

CONCLUSION: Improvements in HRQOL were observed with abatacept, providing real-life tangible benefits to children with JIA and their parents/caregivers.

%B Arthritis Care Res (Hoboken) %V 62 %P 1542-51 %8 2010 Nov %G eng %N 11 %1 http://www.ncbi.nlm.nih.gov/pubmed/20597110?dopt=Abstract %R 10.1002/acr.20283 %0 Journal Article %J Ann Rheum Dis %D 2010 %T EULAR/PRINTO/PRES criteria for Henoch-Schönlein purpura, childhood polyarteritis nodosa, childhood Wegener granulomatosis and childhood Takayasu arteritis: Ankara 2008. Part I: Overall methodology and clinical characterisation. %A Ruperto, Nicolino %A Ozen, Seza %A Pistorio, Angela %A Dolezalova, Pavla %A Brogan, Paul %A Cabral, David A %A Cuttica, Ruben %A Khubchandani, Raju %A Lovell, Daniel J %A O'Neil, Kathleen M %A Quartier, Pierre %A Ravelli, Angelo %A Iusan, Silvia M %A Filocamo, Giovanni %A Magalhães, Claudia Saad %A Unsal, Erbil %A Oliveira, Sheila %A Bracaglia, Claudia %A Bagga, Arvind %A Stanevicha, Valda %A Manzoni, Silvia Magni %A Pratsidou, Polyxeni %A Lepore, Loredana %A Espada, Graciela %A Kone-Paut, Isabella %A Paut, Isabelle Kone %A Zulian, Francesco %A Barone, Patrizia %A Bircan, Zelal %A Maldonado, Maria del Rocio %A Russo, Ricardo %A Vilca, Iris %A Tullus, Kjell %A Cimaz, Rolando %A Horneff, Gerd %A Anton, Jordi %A Garay, Stella %A Nielsen, Susan %A Barbano, Giancarlo %A Martini, Alberto %K Adolescent %K Biopsy %K Child %K Delphi Technique %K Granulomatosis with Polyangiitis %K Humans %K International Cooperation %K Internet %K Polyarteritis Nodosa %K Purpura, Schoenlein-Henoch %K Reproducibility of Results %K Takayasu Arteritis %X

OBJECTIVES: To report methodology and overall clinical, laboratory and radiographic characteristics for Henoch-Schönlein purpura (HSP), childhood polyarteritis nodosa (c-PAN), c-Wegener granulomatosis (c-WG) and c-Takayasu arteritis (c-TA) classification criteria.

METHODS: The preliminary Vienna 2005 consensus conference, which proposed preliminary criteria for paediatric vasculitides, was followed by a EULAR/PRINTO/PRES - supported validation project divided into three main steps. Step 1: retrospective/prospective web-data collection for HSP, c-PAN, c-WG and c-TA, with age at diagnosis

RESULTS: A total of 1183/1398 (85%) samples collected were available for analysis: 827 HSP, 150 c-PAN, 60 c-WG, 87 c-TA and 59 c-other. Prevalence, signs/symptoms, laboratory, biopsy and imaging reports were consistent with the clinical picture of the four c-vasculitides. A representative subgroup of 280 patients was blinded to the treating physician diagnosis and classified by a consensus panel, with a kappa-agreement of 0.96 for HSP (95% CI 0.84 to 1), 0.88 for c-WG (95% CI 0.76 to 0.99), 0.84 for c-TA (95% CI 0.73 to 0.96) and 0.73 for c-PAN (95% CI 0.62 to 0.84), with an overall kappa of 0.79 (95% CI 0.73 to 0.84).

CONCLUSION: EULAR/PRINTO/PRES propose validated classification criteria for HSP, c-PAN, c-WG and c-TA, with substantial/almost perfect agreement with the final consensus classification or original treating physician diagnosis.

%B Ann Rheum Dis %V 69 %P 790-7 %8 2010 May %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/20388738?dopt=Abstract %R 10.1136/ard.2009.116624