Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


Clinically Meaningful Improvements in Health-Related Quality of Life, Pain and Sleep Quality in Children with Polyarticular Juvenile Idiopathic Arthritis Treated with Abatacept over the Long Term.

Lovell3,  Daniel J., Ruperto15,  Nicolino, Quartier19,  Pierre, Paz13,  Eliana, Rubio-Perez10,  Nadina, Silva5,  Clovis A., Abud-Mendoza6,  Carlos

Bristol-Myers Squibb, NJ
Hospital Universitario "Dr. J. E. Gonzalez", Monterrey, Mexico
Hospital Universitario La Fe, Valencia, Spain
Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil
Instituto de Salud del Nino, Lima, Peru
Instituto Portugues de Reumatologia, Lisbon, Portugal
IRCCS G Gaslini, Pediatria II-PRINTO, Università di Genova, Genova, Italy
Istituto Gaetano Pini, Milan, Italy
Universidade de São Paulo, São Paulo, Brazil
Universidade Estadual Paulista, Botucatu, Brazil
Universite Paris-Descartes and Centre de Reference National Pour les Arthrites, Paris, France
Bristol-Myers Squibb, Braine-l'Alleud, Belgium
Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Hôpital Universitaire Hautepierre, Strasbourg, France
Hospital Das Clinicas, Sao Paulo, Brazil
Hospital General "Dr Ignacio Morones Prieto", San Luis Potosì, Mexico
Hospital General de México and Universidad Nacional Autónoma de México, Mexico City, Mexico
Hospital Israelita Albert Einstein, Research Institute, São Paulo, Brazil
Hospital San Javier, Rheumatology, Guadalajara, Jalisco, Mexico

Background:

Systemic inflammation, chronic arthritis and possible joint damage can lead to functional impairment and diminished health-related quality of life (HRQoL) in children and adolescents with juvenile idiopathic arthritis (JIA). In a double-blind (DB), placebo-controlled, randomized withdrawal trial (RWT)1 in subjects with polyarticular JIA, abatacept significantly improved multiple aspects of HRQoL, pain and sleep quality2. Here we report follow-up data on these variables for up to 31 months of treatment, including 21 months of the long-term extension (LTE) of this trial.

Methods:

Subjects in the RWT treated with abatacept who achieved an ACR Pedi 30 response in a 4-month open-label lead-in were randomized 1:1 to DB abatacept or placebo for 6 months or until flare2. Subjects eligible to enter the open-label LTE (10 mg/kg abatacept) included ACR Pedi 30 non-responders (NR) from the lead-in who did not enter the DB period, and subjects randomized into the DB phase who either flared or completed the 6-month DB period. HRQoL was assessed by the Child Health Questionnaire (CHQ), which includes 15 health concepts, sleep quality by the Children's Sleep Habits Questionnaire (CSHQ) (score 0–100) and parent global assessment of pain by 0–100 mm VAS. Mean CHQ component scores are also presented for healthy children3. Data up to Month 21 of the LTE are presented for subjects who entered the LTE (either NR from the open-label lead-in or subjects treated with abatacept during the DB period), and who had data available at the visit of interest (as-observed).

Results:

At study entry, subjects had considerably lower HRQoL than the general population1. Mean changes in CHQ components from baseline to Month 31 generally indicated improvements in both patient cohorts, with greater changes seen for DB abatacept patients compared with open-label NRs (Table). Mean scores at Month 31 for each CHQ component were generally comparable to scores for healthy children. Reductions from baseline in CSHQ scores and pain also were comparable by Month 31 for the DB abatacept versus NR cohorts: mean (95% CI) changes in CHSQ total scores were –3.5 (–6.5, –0.5) versus –2.9 (–6.3, 0.6), and in parent global assessment of pain were –31.2 (–37.8, –24.6) versus –20.6 (–30.2, –10.9) (n=28, n=16, n=50 and n=22, respectively).

 Healthy childrenDB abatacept N = 58‡Open-label NR N = 36‡  
 Mean (SD) scoresMean (SD) score at Month 21Mean change to Month 21Mean (SD) score at Month 21Mean change to Month 21
CHQ components*     
Global health86.7 (16.6)73.8 (22.1)§31.2 (22.9, 39.4)§65.2 (27.4)25.9 (12.3, 39.6)
Physical function97.2 (10.8)79.6 (28.1)24.4 (16.9, 31.8)78.3 (27.8)20.2 (7.7, 32.7)
Role/Social Emotional96.7 (12.8)86.7 (25.2)17.2 (7.3, 27.1)82.3 (28.8)4.0 (-8.4, 16.4)
Role/Social Physical96.3 (12.6)87.3 (25.5)20.9 (10.7, 31.3)78.0 (31.0)5.3 (-7.3, 17.9)
Pain/discomfort89.7 (16.4)80.6 (20.5)[par]31.6 (23.4, 39.8)[par]68.6 (25.7)19.6 (10.5, 28.6)
Behaviour79.5 (14.5)82.2 (12.7)12.2 (6.7, 17.6)82.1 (15.0)12.9 (6.8, 19.0)
Global behaviour80.0 (18.8)78.0 (19.9)13.3 (5.8, 20.9)75.7 (22.4)15.0 (0.3, 29.7)
Mental health78.5 (14.1)78.3 (18.5)12.7 (7.2, 18.1)75.0 (19.0)**7.7 (-2.1, 17.5)**
Self esteem81.8 (16.6)79.4 (20.1)11.8 (6.2, 17.4)81.9 (18.4)**14.1 (2.5, 25.7)**
General health77.7 (15.4)62.7 (15.5)11.9 (7.0, 16.8)59.9 (17.1)12.5 (4.8, 20.2)
Change in health†59.4 (19.0)4.5 (0.8)1.0 (0.7, 1.4)4.4 (1.0)**1.1 (0.5, 1.7)**
Parental emotional impact79.7 (23.0)65.0 (32.6)22.2 (12.8, 31.7)70.1 (30.4)18.2 (5.1, 31.3)
Parental time impact90.9 (18.3)88.2 (21.0)20.7 (12.4, 29.0)79.3 (27.7)3.0 (-7.2, 13.3)
Family activity89.7 (14.4)89.6 (15.9)13.0 (7.8, 18.3)79.7 (27.3)5.7 (-7.9, 19.3)
Family cohesion75.3 (20.4)76.5 (19.7)10.9 (3.6, 18.2)71.8 (24.9)3.6 (-9.8, 17.1)
*Higher scores on the CHQ indicate better HRQoL;†Note that change in health scores for subjects in this study are on a 1–5 scale, whereas those for healthy children have been transformed to a 0–100 scale;‡N is the number of patients who entered the LTE from each group, and data shown are for patients with data available at baseline and the visit of interest, with n = 51 for DB abatacept and n = 22 for open-label NRs, except§n = 48,[par]n = 50;**n = 21

Conclusions:

Treatment with open-label abatacept for up to 31 months resulted in improvements in multiple aspects of HRQoL, to within the range of healthy children, for subjects with JIA, including those who were ACR Pedi 30 non-responders in the lead-in period. These data suggest that long-term abatacept treatment can provide real-life tangible health-related benefits to children with polyarticular JIA.

1Ruperto, Net al. Arthritis Rheum 2010;62:1792–1802

2Ruperto, Net al. Ann Rheum Dis 2009;68(Suppl3):160.AbstractOP-0268

3Ruperto, Net al. Clin Exp Rheumatol 2001;19:S1–9

To cite this abstract, please use the following information:
Lovell, Daniel J., Ruperto, Nicolino, Quartier, Pierre, Paz, Eliana, Rubio-Perez, Nadina, Silva, Clovis A., et al; Clinically Meaningful Improvements in Health-Related Quality of Life, Pain and Sleep Quality in Children with Polyarticular Juvenile Idiopathic Arthritis Treated with Abatacept over the Long Term. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1407
DOI: 10.1002/art.29173

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