Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis.

Nicolino Ruperto, Daniel J. Lovell, Tracy Li, Flavio Sztajnbok, Claudia Goldenstein-Schainberg, Morton Scheinberg, Inmaculada Calvo Penades, Michael Fischbach, Javier Orozco Alcala, Philip J. Hashkes, Christine Hom, Lawrence Jung, Loredana Lepore, Sheila Oliveira, Carol Wallace, Maria Alessio, Pierre Quartier, Elisabetta Cortis, Anne Eberhard, Gabriele SimoniniIrene Lemelle, Elizabeth Candell Chalom, Leonard H. Sigal, Alan Block, Allison Covucci, Marleen Nys, Alberto Martini, Edward H. Giannini, Rheumatology International Trials Organisation (PRINTO) Paediatric Rheumatology International Trials Organisation (PRINTO), Rheumatology Collaborative Study Group (PRCSG) Pediatric Rheumatology Collaborative Study Group (PRCSG)

Research output: Contribution to journalArticle

Abstract

To assess health-related quality of life (HRQOL) in abatacept-treated children/adolescents with juvenile idiopathic arthritis (JIA). 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. 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). Improvements in HRQOL were observed with abatacept, providing real-life tangible benefits to children with JIA and their parents/caregivers.

Original languageEnglish
Pages (from-to)1542-1551
Number of pages10
JournalArthritis Care and Research
Volume62
Issue number11
Publication statusPublished - Nov 2010

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ASJC Scopus subject areas

  • Medicine(all)

Cite this

Ruperto, N., Lovell, D. J., Li, T., Sztajnbok, F., Goldenstein-Schainberg, C., Scheinberg, M., Penades, I. C., Fischbach, M., Alcala, J. O., Hashkes, P. J., Hom, C., Jung, L., Lepore, L., Oliveira, S., Wallace, C., Alessio, M., Quartier, P., Cortis, E., Eberhard, A., ... Pediatric Rheumatology Collaborative Study Group (PRCSG), R. C. S. G. PRCSG. (2010). Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis. Arthritis Care and Research, 62(11), 1542-1551.