title: Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis.
abstract: 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).
  
  
  CONCLUSIONS
  Improvements in HRQOL were observed with abatacept, providing real-life tangible benefits to children with JIA and their parents/caregivers.
authors.affiliation: Università di Genova, Genoa, Italy. nicolaruperto@ospedale-gaslini.ge.it
authors.forename: Nicolino
authors.initials: N
authors.lastname: Ruperto
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Lovell
authors.forename: Tracy
authors.initials: T
authors.lastname: Li
authors.forename: Flavio
authors.initials: F
authors.lastname: Sztajnbok
authors.forename: Claudia
authors.initials: C
authors.lastname: Goldenstein-Schainberg
authors.forename: Morton
authors.initials: M
authors.lastname: Scheinberg
authors.forename: Inmaculada Calvo
authors.initials: IC
authors.lastname: Penades
authors.forename: Michael
authors.initials: M
authors.lastname: Fischbach
authors.forename: Javier Orozco
authors.initials: JO
authors.lastname: Alcala
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Hashkes
authors.forename: Christine
authors.initials: C
authors.lastname: Hom
authors.forename: Lawrence
authors.initials: L
authors.lastname: Jung
authors.forename: Loredana
authors.initials: L
authors.lastname: Lepore
authors.forename: Sheila
authors.initials: S
authors.lastname: Oliveira
authors.forename: Carol
authors.initials: C
authors.lastname: Wallace
authors.forename: Maria
authors.initials: M
authors.lastname: Alessio
authors.forename: Pierre
authors.initials: P
authors.lastname: Quartier
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Cortis
authors.forename: Anne
authors.initials: A
authors.lastname: Eberhard
authors.forename: Gabriele
authors.initials: G
authors.lastname: Simonini
authors.forename: Irene
authors.initials: I
authors.lastname: Lemelle
authors.forename: Elizabeth Candell
authors.initials: EC
authors.lastname: Chalom
authors.forename: Leonard H
authors.initials: LH
authors.lastname: Sigal
authors.forename: Alan
authors.initials: A
authors.lastname: Block
authors.forename: Allison
authors.initials: A
authors.lastname: Covucci
authors.forename: Marleen
authors.initials: M
authors.lastname: Nys
authors.forename: Alberto
authors.initials: A
authors.lastname: Martini
authors.forename: Edward H
authors.initials: EH
authors.lastname: Giannini
mesh_terms: D000069594:Abatacept; D000293:Adolescent; D001171:Arthritis, Juvenile / Q000188:drug therapy / Q000503:physiopathology / Q000523:psychology*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D008297:Male; D010146:Pain / Q000188:drug therapy / Q000503:physiopathology / Q000523:psychology*; D011788:Quality of Life / Q000523:psychology*; D012894:Sleep Stages / Q000502:physiology; D011795:Surveys and Questionnaires
chemical_list: D018796:Immunoconjugates; D000069594:Abatacept