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 language | English |
|---|---|
| Pages (from-to) | 1542-1551 |
| Number of pages | 10 |
| Journal | Arthritis Care and Research |
| Volume | 62 |
| Issue number | 11 |
| Publication status | Published - Nov 2010 |
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ASJC Scopus subject areas
- Medicine(all)
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Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis. / Ruperto, Nicolino; Lovell, Daniel J.; Li, Tracy; Sztajnbok, Flavio; Goldenstein-Schainberg, Claudia; Scheinberg, Morton; Penades, Inmaculada Calvo; Fischbach, Michael; Alcala, Javier Orozco; Hashkes, Philip J.; Hom, Christine; Jung, Lawrence; Lepore, Loredana; Oliveira, Sheila; Wallace, Carol; Alessio, Maria; Quartier, Pierre; Cortis, Elisabetta; Eberhard, Anne; Simonini, Gabriele; Lemelle, Irene; Chalom, Elizabeth Candell; Sigal, Leonard H.; Block, Alan; Covucci, Allison; Nys, Marleen; Martini, Alberto; Giannini, Edward H.; Paediatric Rheumatology International Trials Organisation (PRINTO), Rheumatology International Trials Organisation (PRINTO); Pediatric Rheumatology Collaborative Study Group (PRCSG), Rheumatology Collaborative Study Group (PRCSG).
In: Arthritis Care and Research, Vol. 62, No. 11, 11.2010, p. 1542-1551.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis.
AU - Ruperto, Nicolino
AU - Lovell, Daniel J.
AU - Li, Tracy
AU - Sztajnbok, Flavio
AU - Goldenstein-Schainberg, Claudia
AU - Scheinberg, Morton
AU - Penades, Inmaculada Calvo
AU - Fischbach, Michael
AU - Alcala, Javier Orozco
AU - Hashkes, Philip J.
AU - Hom, Christine
AU - Jung, Lawrence
AU - Lepore, Loredana
AU - Oliveira, Sheila
AU - Wallace, Carol
AU - Alessio, Maria
AU - Quartier, Pierre
AU - Cortis, Elisabetta
AU - Eberhard, Anne
AU - Simonini, Gabriele
AU - Lemelle, Irene
AU - Chalom, Elizabeth Candell
AU - Sigal, Leonard H.
AU - Block, Alan
AU - Covucci, Allison
AU - Nys, Marleen
AU - Martini, Alberto
AU - Giannini, Edward H.
AU - Paediatric Rheumatology International Trials Organisation (PRINTO), Rheumatology International Trials Organisation (PRINTO)
AU - Pediatric Rheumatology Collaborative Study Group (PRCSG), Rheumatology Collaborative Study Group (PRCSG)
PY - 2010/11
Y1 - 2010/11
N2 - 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.
AB - 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.
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UR - http://www.scopus.com/inward/citedby.url?scp=79952063531&partnerID=8YFLogxK
M3 - Article
C2 - 20597110
AN - SCOPUS:79952063531
VL - 62
SP - 1542
EP - 1551
JO - Arthritis care and research : the official journal of the Arthritis Health Professions Association
JF - Arthritis care and research : the official journal of the Arthritis Health Professions Association
SN - 0893-7524
IS - 11
ER -