TY - JOUR T1 - Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis. JF - Arthritis Care Res (Hoboken) Y1 - 2010 A1 - Ruperto, Nicolino A1 - Lovell, Daniel J A1 - Li, Tracy A1 - Sztajnbok, Flavio A1 - Goldenstein-Schainberg, Claudia A1 - Scheinberg, Morton A1 - Penades, Inmaculada Calvo A1 - Fischbach, Michael A1 - Alcala, Javier Orozco A1 - Hashkes, Philip J A1 - Hom, Christine A1 - Jung, Lawrence A1 - Lepore, Loredana A1 - Oliveira, Sheila A1 - Wallace, Carol A1 - Alessio, Maria A1 - Quartier, Pierre A1 - Cortis, Elisabetta A1 - Eberhard, Anne A1 - Simonini, Gabriele A1 - Lemelle, Irene A1 - Chalom, Elizabeth Candell A1 - Sigal, Leonard H A1 - Block, Alan A1 - Covucci, Allison A1 - Nys, Marleen A1 - Martini, Alberto A1 - Giannini, Edward H KW - Adolescent KW - Arthritis, Juvenile KW - Child KW - Double-Blind Method KW - Female KW - Health Status KW - Humans KW - Immunoconjugates KW - Male KW - Pain KW - Quality of Life KW - Questionnaires KW - Sleep Stages AB -

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.

VL - 62 IS - 11 U1 - http://www.ncbi.nlm.nih.gov/pubmed/20597110?dopt=Abstract ER -