%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 Predictors of poor response to methotrexate in polyarticular-course juvenile idiopathic arthritis: analysis of the PRINTO methotrexate trial. %A Vilca, Iris %A Munitis, Pablo Garcia %A Pistorio, Angela %A Ravelli, Angelo %A Buoncompagni, Antonella %A Bica, Blanca %A Campos, Lucia %A Häfner, Renate %A Hofer, Michael %A Ozen, Seza %A Huemer, Christian %A Bae, Sang Cheol %A Sztajnbok, Flavio %A Arguedas, Olga %A Foeldvari, Ivan %A Huppertz, Hans Iko %A Gamir, María Luz %A Magnusson, Bo %A Dressler, Frank %A Uziel, Yosef %A van Rossum, Marion A J %A Hollingworth, Peter %A Cawkwell, Gail %A Martini, Alberto %A Ruperto, Nicolino %K Adolescent %K Antibodies, Antinuclear %K Antirheumatic Agents %K Arthritis, Juvenile %K Child %K Child, Preschool %K Disability Evaluation %K Female %K Follow-Up Studies %K Humans %K Immunosuppressive Agents %K Male %K Methotrexate %K Prognosis %K Treatment Outcome %X

OBJECTIVES: To determine whether baseline demographic, clinical, articular and laboratory variables predict methotrexate (MTX) poor response in polyarticular-course juvenile idiopathic arthritis.

METHODS: Patients newly treated for 6 months with MTX enrolled in the Paediatric Rheumatology International Trials Organization (PRINTO) MTX trial. Bivariate and logistic regression analyses were used to identify baseline predictors of poor response according to the American College of Rheumatology pediatric (ACR-ped) 30 and 70 criteria.

RESULTS: In all, 405/563 (71.9%) of patients were women; median age at onset and disease duration were 4.3 and 1.4 years, respectively, with anti-nuclear antibody (ANA) detected in 259/537 (48.2%) patients. With multivariate logistic regression analysis, the most important determinants of ACR-ped 70 non-responders were: disease duration > 1.3 years (OR 1.93), ANA negativity (OR 1.77), Childhood Health Assessment Questionnaire (CHAQ) disability index > 1.125 (OR 1.65) and the presence of right and left wrist activity (OR 1.55). Predictors of ACR-ped 30 non-responders were: ANA negativity (OR 1.92), CHAQ disability index > 1.14 (OR 2.18) and a parent's evaluation of child's overall well-being < or = 4.69 (OR 2.2).

CONCLUSION: The subgroup of patients with longer disease duration, ANA negativity, higher disability and presence of wrist activity were significantly associated with a poorer response to a 6-month MTX course.

%B Ann Rheum Dis %V 69 %P 1479-83 %8 2010 Aug %G eng %N 8 %1 http://www.ncbi.nlm.nih.gov/pubmed/20525842?dopt=Abstract %R 10.1136/ard.2009.120840