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) receivedabatacept 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.
RCT Entities:
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: Ashwin N Ananthakrishnan; Hamed Khalili; Gauree G Konijeti; Leslie M Higuchi; Punyanganie de Silva; Charles S Fuchs; James M Richter; Eva S Schernhammer; Andrew T Chan Journal: Clin Gastroenterol Hepatol Date: 2014-04-26 Impact factor: 11.382
Authors: Sarah Ringold; Sheila T Angeles-Han; Timothy Beukelman; Daniel Lovell; Carlos A Cuello; Mara L Becker; Robert A Colbert; Brian M Feldman; Polly J Ferguson; Harry Gewanter; Jaime Guzman; Jennifer Horonjeff; Peter A Nigrovic; Michael J Ombrello; Murray H Passo; Matthew L Stoll; C Egla Rabinovich; Rayfel Schneider; Olha Halyabar; Kimberly Hays; Amit Aakash Shah; Nancy Sullivan; Ann Marie Szymanski; Marat Turgunbaev; Amy Turner; James Reston Journal: Arthritis Care Res (Hoboken) Date: 2019-04-25 Impact factor: 4.794
Authors: Sarah Ringold; Sheila T Angeles-Han; Timothy Beukelman; Daniel Lovell; Carlos A Cuello; Mara L Becker; Robert A Colbert; Brian M Feldman; Polly J Ferguson; Harry Gewanter; Jaime Guzman; Jennifer Horonjeff; Peter A Nigrovic; Michael J Ombrello; Murray H Passo; Matthew L Stoll; C Egla Rabinovich; Rayfel Schneider; Olha Halyabar; Kimberly Hays; Amit Aakash Shah; Nancy Sullivan; Ann Marie Szymanski; Marat Turgunbaev; Amy Turner; James Reston Journal: Arthritis Rheumatol Date: 2019-04-25 Impact factor: 10.995
Authors: Sarah Ringold; Pamela F Weiss; Timothy Beukelman; Esi Morgan DeWitt; Norman T Ilowite; Yukiko Kimura; Ronald M Laxer; Daniel J Lovell; Peter A Nigrovic; Angela Byun Robinson; Richard K Vehe Journal: Arthritis Rheum Date: 2013-10
Authors: Ashwin N Ananthakrishnan; Millie D Long; Christopher F Martin; Robert S Sandler; Michael D Kappelman Journal: Clin Gastroenterol Hepatol Date: 2013-02-01 Impact factor: 11.382