TY - JOUR
T1 - Functional Ability and Health-Related Quality of Life in Randomized Controlled Trials of Tocilizumab in Patients With Juvenile Idiopathic Arthritis
AU - for the Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group
AU - Brunner, Hermine I.
AU - Chen, Chen
AU - Bovis, Francesca
AU - De Benedetti, Fabrizio
AU - Espada, Graciela
AU - Joos, Rik
AU - Akikusa, Jonathan
AU - Chaitow, Jeffrey
AU - Boteanu, Alina Lucica
AU - Kimura, Yukiko
AU - Rietschel, Christoph
AU - Siri, Daniel
AU - Smolewska, Elzbieta
AU - Schmeling, Heinrike
AU - Brown, Diane E.
AU - Martini, Alberto
AU - Lovell, Daniel J.
AU - Huang, Bin
AU - Ruperto, Nicolino
N1 - Publisher Copyright:
© 2020, American College of Rheumatology
PY - 2021/9
Y1 - 2021/9
N2 - Objective: To evaluate changes in health-related quality of life (HRQoL) and disability in children with systemic juvenile idiopathic arthritis (JIA) or polyarticular JIA treated with tocilizumab. Methods: Secondary analyses of two double-blind, placebo-controlled trials of intravenous tocilizumab in children with active systemic JIA or polyarticular JIA were conducted. Patient-reported outcomes of disability (Childhood Health Assessment Questionnaire [C-HAQ]), HRQoL (Child Health Questionnaire Parent Form 50 [CHQ-P50], health concepts, physical summary score [CHQ-P50-PhS], psychosocial summary score [CHQ-P50-PsS]), pain, and well-being (100-mm visual analog scale [VAS]) were measured at weeks 0 and 12 for systemic JIA, weeks 16 and 40 for polyarticular JIA, and week 104 for both JIA subgroups. Results: The trial included 112 patients with systemic JIA and 188 patients with polyarticular JIA. In patients with polyarticular JIA, the mean ± SD C-HAQ score decreased from 1.39 ± 0.74 at baseline to 0.67 ± 0.65 at week 16 (P < 0.001). In patients with systemic JIA, the mean ± SD CHQ-P50-PhS improved more with tocilizumab therapy than with placebo at week 12 (7.3 ± 10.2 versus 2.4 ± 10.6) (P < 0.05). Almost all mean CHQ-P50 health concept scores, CHQ-P50-PsS, and CHQ-P50-PhS improved (P ≤ 0.002) by week 104 for patients with systemic JIA. Patients with polyarticular JIA and patients with systemic JIA showed significant reductions in disability (mean ± SD C-HAQ scores of −1.09 ± 0.71 and −1.17 ± 0.80, respectively), improvements in well-being (mean ± SD well-being VAS scores of −43.76 ± 26.61 and −51.53 ± 23.57, respectively), and decreases in pain (mean ± SD pain VAS scores of −41.56 ± 31.06 and −51.26 ± 26.79, respectively) (P < 0.001); in patients with polyarticular JIA and patients with systemic JIA who were treated with tocilizumab, 92.9% of polyarticular JIA patients and 96.8% of systemic JIA patients reported no more than minimal pain (a score of ≤35 mm on the VAS) at week 104. Conclusion: Tocilizumab treatment was associated with significantly reduced disability and pain and improved HRQoL in patients with systemic JIA and polyarticular JIA.
AB - Objective: To evaluate changes in health-related quality of life (HRQoL) and disability in children with systemic juvenile idiopathic arthritis (JIA) or polyarticular JIA treated with tocilizumab. Methods: Secondary analyses of two double-blind, placebo-controlled trials of intravenous tocilizumab in children with active systemic JIA or polyarticular JIA were conducted. Patient-reported outcomes of disability (Childhood Health Assessment Questionnaire [C-HAQ]), HRQoL (Child Health Questionnaire Parent Form 50 [CHQ-P50], health concepts, physical summary score [CHQ-P50-PhS], psychosocial summary score [CHQ-P50-PsS]), pain, and well-being (100-mm visual analog scale [VAS]) were measured at weeks 0 and 12 for systemic JIA, weeks 16 and 40 for polyarticular JIA, and week 104 for both JIA subgroups. Results: The trial included 112 patients with systemic JIA and 188 patients with polyarticular JIA. In patients with polyarticular JIA, the mean ± SD C-HAQ score decreased from 1.39 ± 0.74 at baseline to 0.67 ± 0.65 at week 16 (P < 0.001). In patients with systemic JIA, the mean ± SD CHQ-P50-PhS improved more with tocilizumab therapy than with placebo at week 12 (7.3 ± 10.2 versus 2.4 ± 10.6) (P < 0.05). Almost all mean CHQ-P50 health concept scores, CHQ-P50-PsS, and CHQ-P50-PhS improved (P ≤ 0.002) by week 104 for patients with systemic JIA. Patients with polyarticular JIA and patients with systemic JIA showed significant reductions in disability (mean ± SD C-HAQ scores of −1.09 ± 0.71 and −1.17 ± 0.80, respectively), improvements in well-being (mean ± SD well-being VAS scores of −43.76 ± 26.61 and −51.53 ± 23.57, respectively), and decreases in pain (mean ± SD pain VAS scores of −41.56 ± 31.06 and −51.26 ± 26.79, respectively) (P < 0.001); in patients with polyarticular JIA and patients with systemic JIA who were treated with tocilizumab, 92.9% of polyarticular JIA patients and 96.8% of systemic JIA patients reported no more than minimal pain (a score of ≤35 mm on the VAS) at week 104. Conclusion: Tocilizumab treatment was associated with significantly reduced disability and pain and improved HRQoL in patients with systemic JIA and polyarticular JIA.
UR - https://www.scopus.com/pages/publications/85111625356
U2 - 10.1002/acr.24384
DO - 10.1002/acr.24384
M3 - Article
C2 - 32702212
AN - SCOPUS:85111625356
SN - 2151-464X
VL - 73
SP - 1264
EP - 1274
JO - Arthritis Care and Research
JF - Arthritis Care and Research
IS - 9
ER -