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Patient-Reported Outcomes Among Patients Ages Two to Seventeen Years With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Subcutaneous Abatacept: Two-Year Results From an International Phase III Study.

Publication ,  Journal Article
Ruperto, N; Lovell, DJ; Berman, A; Ávila-Zapata, F; Horneff, G; Alessio, M; Becker, ML; Belot, A; Burgos-Vargas, R; Gamir, ML; Scheibel, IM ...
Published in: Arthritis Care Res (Hoboken)
August 2023

OBJECTIVE: To describe longitudinal changes in patient-reported outcomes (PROs) in children with polyarticular-course juvenile idiopathic arthritis (pJIA) treated with subcutaneous abatacept. METHODS: Secondary analysis of a single-arm, open-label 24-month study of patients ages 6-17 years and 2-5 years. PROs included Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), parent global assessment of child well-being (PaGA), pain assessment, and Activity Limitation Questionnaire (ALQ). Clinical outcomes included 50% or greater improvement in JIA American College of Rheumatology (ACR) criteria, clinically inactive disease, and Juvenile Arthritis Disease Activity Score. RESULTS: For the 6- to 17-year-old (n = 173) and 2- to 5-year-old (n = 46) cohorts, respectively, median (Q1, Q3) changes from baseline in CHAQ-DI at months 4 and 24 were -0.3 (-0.8, 0.0) and -0.5 (-1.0, -0.1), and -0.4 (-0.8, 0.0) and -0.5 (-1.0--0.1). Median pain scores were below cutoff threshold for clinically relevant pain (<35 mm) by month 1 (6 to 17 years, 32.3 mm; 2 to 5 years, 25.7 mm), reaching a nadir at month 24 (6 to 17 years, 6.0 mm; 2 to 5 years, 2.0 mm). For the 6- to 17-year-old and 2- to 5-year-old cohorts, respectively, median PaGA scores were 47.8 (n = 172) and 42.1 (n = 46) at baseline and 6.3 (n = 107) and 2.0 (n = 37) at month 24. In both cohorts, ALQ components improved from baseline to month 4 and were largely maintained to month 24. Clinical outcomes improved through to month 24. CONCLUSION: Early and sustained PRO improvements were reported in this phase III, open-label trial of subcutaneous abatacept in patients with pJIA.

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Published In

Arthritis Care Res (Hoboken)

DOI

EISSN

2151-4658

Publication Date

August 2023

Volume

75

Issue

8

Start / End Page

1804 / 1814

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Patient Reported Outcome Measures
  • Pain
  • Humans
  • Child, Preschool
  • Child
  • Arthritis, Juvenile
  • Antirheumatic Agents
  • Adolescent
  • Abatacept
 

Citation

APA
Chicago
ICMJE
MLA
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Ruperto, N., Lovell, D. J., Berman, A., Ávila-Zapata, F., Horneff, G., Alessio, M., … Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation, . (2023). Patient-Reported Outcomes Among Patients Ages Two to Seventeen Years With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Subcutaneous Abatacept: Two-Year Results From an International Phase III Study. Arthritis Care Res (Hoboken), 75(8), 1804–1814. https://doi.org/10.1002/acr.24989
Ruperto, Nicolino, Daniel J. Lovell, Alberto Berman, Francisco Ávila-Zapata, Gerd Horneff, Maria Alessio, Mara L. Becker, et al. “Patient-Reported Outcomes Among Patients Ages Two to Seventeen Years With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Subcutaneous Abatacept: Two-Year Results From an International Phase III Study.Arthritis Care Res (Hoboken) 75, no. 8 (August 2023): 1804–14. https://doi.org/10.1002/acr.24989.
Ruperto N, Lovell DJ, Berman A, Ávila-Zapata F, Horneff G, Alessio M, Becker ML, Belot A, Burgos-Vargas R, Gamir ML, Goldenstein-Schainberg C, Scheibel IM, Terreri MT, Zemel L, Zhuo J, Askelson M, Wong R, Martini A, Brunner HI, Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Patient-Reported Outcomes Among Patients Ages Two to Seventeen Years With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Subcutaneous Abatacept: Two-Year Results From an International Phase III Study. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1804–1814.
Journal cover image

Published In

Arthritis Care Res (Hoboken)

DOI

EISSN

2151-4658

Publication Date

August 2023

Volume

75

Issue

8

Start / End Page

1804 / 1814

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Patient Reported Outcome Measures
  • Pain
  • Humans
  • Child, Preschool
  • Child
  • Arthritis, Juvenile
  • Antirheumatic Agents
  • Adolescent
  • Abatacept