Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis.
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.
Ruperto
Nicolino
N
Università di Genova, Genoa, Italy. nicolaruperto@ospedale-gaslini.ge.it
Lovell
Daniel J
DJ
Li
Tracy
T
Sztajnbok
Flavio
F
Goldenstein-Schainberg
Claudia
C
Scheinberg
Morton
M
Penades
Inmaculada Calvo
IC
Fischbach
Michael
M
Alcala
Javier Orozco
JO
Hashkes
Philip J
PJ
Hom
Christine
C
Jung
Lawrence
L
Lepore
Loredana
L
Oliveira
Sheila
S
Wallace
Carol
C
Alessio
Maria
M
Quartier
Pierre
P
Cortis
Elisabetta
E
Eberhard
Anne
A
Simonini
Gabriele
G
Lemelle
Irene
I
Chalom
Elizabeth Candell
EC
Sigal
Leonard H
LH
Block
Alan
A
Covucci
Allison
A
Nys
Marleen
M
Martini
Alberto
A
Giannini
Edward H
EH
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
D018796:Immunoconjugates; D000069594:Abatacept