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Functional Ability and Health-Related Quality of Life in Randomized Controlled Trials of Tocilizumab in Patients With Juvenile Idiopathic Arthritis.
- Source :
-
Arthritis care & research [Arthritis Care Res (Hoboken)] 2021 Sep; Vol. 73 (9), pp. 1264-1274. Date of Electronic Publication: 2021 Aug 02. - Publication Year :
- 2021
-
Abstract
- 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.<br />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.<br />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.<br />Conclusion: Tocilizumab treatment was associated with significantly reduced disability and pain and improved HRQoL in patients with systemic JIA and polyarticular JIA.<br /> (© 2020, American College of Rheumatology.)
- Subjects :
- Administration, Intravenous
Adolescent
Age Factors
Antibodies, Monoclonal, Humanized adverse effects
Antirheumatic Agents adverse effects
Arthritis, Juvenile diagnosis
Arthritis, Juvenile physiopathology
Child
Child, Preschool
Clinical Trials, Phase III as Topic
Disability Evaluation
Female
Humans
Male
Pain Measurement
Patient Reported Outcome Measures
Randomized Controlled Trials as Topic
Recovery of Function
Time Factors
Treatment Outcome
Antibodies, Monoclonal, Humanized administration & dosage
Antirheumatic Agents administration & dosage
Arthritis, Juvenile drug therapy
Functional Status
Quality of Life
Subjects
Details
- Language :
- English
- ISSN :
- 2151-4658
- Volume :
- 73
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Arthritis care & research
- Publication Type :
- Academic Journal
- Accession number :
- 32702212
- Full Text :
- https://doi.org/10.1002/acr.24384