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).

CONCLUSION:

Improvements in HRQOL were observed with abatacept, providing real-life tangible benefits to children with JIA and their parents/caregivers.

• Authors: Nicolino Ruperto, Daniel J Lovell, Tracy Li, Flavio Sztajnbok, Claudia Goldenstein-Schainberg, Morton Scheinberg, Inmaculada Calvo Penades, Michael Fischbach, Javier Orozco Alcala, Philip J Hashkes, Christine Hom, Lawrence Jung, Loredana Lepore, Sheila Oliveira, Carol Wallace, Maria Alessio, Pierre Quartier, Elisabetta Cortis, Anne Eberhard, Gabriele Simonini, Irene Lemelle, Elizabeth Candell Chalom, Leonard H Sigal, Alan Block, Allison Covucci, Marleen Nys, Alberto Martini, Edward H Giannini, Paediatric Rheumatology International Trials Organisation (PRINTO), Pediatric Rheumatology Collaborative Study Group (PRCSG)
• Journal: Arthritis care & research (Arthritis Care Res (Hoboken)) Vol. 62 Issue 11 Pg. 1542-51 (Nov 2010) ISSN: 2151-4658 [Electronic] United States
• PMID: 20597110 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010 by the American College of Rheumatology.

Chemical References

• Immunoconjugates
• Abatacept

Topics

• Abatacept
• Adolescent
• Arthritis, Juvenile (drug therapy, physiopathology, psychology)
• Child
• Double-Blind Method
• Female
• Health Status
• Humans
• Immunoconjugates (therapeutic use)
• Male
• Pain (drug therapy, physiopathology, psychology)
• Quality of Life (psychology)
• Sleep Stages (physiology)
• Surveys and Questionnaires