Abatacept Improves Health-Related Quality of Life, Pain, Sleep Quality, and Daily Participation in Subjects With Juvenile Idiopathic Arthritis

被引：72

作者：

Ruperto, Nicolino ^{[1
]}

Lovell, Daniel J. ^{[2
]}

Li, Tracy ^{[3
]}

Sztajnbok, Flavio ^{[4
]}

Goldenstein-Schainberg, Claudia ^{[5
]}

Scheinberg, Morton ^{[6
]}

Calvo Penades, Inmaculada ^{[7
]}

Fischbach, Michael ^{[8
]}

Orozco Alcala, Javier ^{[9
]}

Hashkes, Philip J. ^{[10
]}

Hom, Christine ^{[11
]}

Jung, Lawrence ^{[12
]}

Lepore, Loredana ^{[13
]}

Oliveira, Sheila ^{[14
]}

Wallace, Carol ^{[15
]}

Alessio, Maria ^{[16
]}

Quartier, Pierre ^{[17
,18
]}

Cortis, Elisabetta ^{[19
]}

Eberhard, Anne ^{[20
]}

Simonini, Gabriele ^{[21
]}

Lemelle, Irene ^{[22
]}

Chalom, Elizabeth Candell ^{[23
]}

Sigal, Leonard H. ^{[3
]}

Block, Alan ^{[3
]}

Covucci, Allison ^{[3
]}

Nys, Marleen ^{[24
]}

Martini, Alberto ^{[1
]}

Giannini, Edward H. ^{[2
]}

机构：

[1] Univ Genoa, Paediat Rheumatol Int Trials Org, IRCCS G Gaslini, I-16147 Genoa, Italy

[2] Cincinnati Childrens Hosp, Med Ctr, Cincinnati, OH USA

[3] Bristol Myers Squibb Co, Princeton, NJ USA

[4] Hosp Univ Pedro Ernesto, Rio De Janeiro, Brazil

[5] Univ Sao Paulo, Sao Paulo, Brazil

[6] Hosp Israelita Albert Einstein, Res Inst, Sao Paulo, Brazil

[7] Hosp Univ La Fe, Valencia, Spain

[8] Hop Univ Hautepierre, Strasbourg, France

[9] Hosp San Javier, Guadalajara, Jalisco, Mexico

[10] Cleveland Clin Fdn, Cleveland, OH 44195 USA

[11] Maria Fareri Childrens Hosp, New York Med Coll, Valhalla, NY USA

[12] Childrens Natl Med Ctr, Washington, DC 20010 USA

[13] Univ Trieste, IRCCS Burlo Garofolo, Pediat Clin, Trieste, Italy

[14] Inst Puericultura & Pediat Martagao Gesteira, Rio De Janeiro, Brazil

[15] Childrens Hosp & Reg Med Ctr, Seattle, WA USA

[16] Univ Naples Federico II, Naples, Italy

[17] Univ Paris 05, Paris, France

[18] Hop Necker Enfants Malad, Ctr Reference Natl Arthrit Juveniles, Paris, France

[19] Osped Pediat Bambino Gesu, Rome, Italy

[20] Schneider Childrens Hosp, New York, NY USA

[21] Osped A Meyer, Florence, Italy

[22] Ctr Hosp Univ Brabois, Vandoeuvre Les Nancy, France

[23] St Barnabas Hosp, Livingston, NJ USA

[24] Bristol Myers Squibb Co, Braine Lalleud, Belgium

来源：

ARTHRITIS CARE & RESEARCH | 2010年 / 62卷 / 11期

关键词：

COSTIMULATION MODULATOR ABATACEPT; RHEUMATOID-ARTHRITIS; DOUBLE-BLIND; PEDIATRIC RHEUMATOLOGY; CHILDREN; METHOTREXATE; EFFICACY; SAFETY; DISEASE; TRIAL;

D O I：

10.1002/acr.20283

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：1542 / 1551

页数：10

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