Document Type
Article
Publication Date
4-11-2017
Identifier
PMCID: PMC5387287 DOI: 10.1186/s12969-017-0157-1
Abstract
OBJECTIVES: To assess the feasibility of studying the comparative effectiveness of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) consensus treatment plans (CTPs) for systemic Juvenile Idiopathic Arthritis (JIA) using an observational registry.
METHODS: Untreated systemic JIA patients enrolled in the CARRA Registry were begun on one of 4 CTPs chosen by the treating physician and patient/family (glucocorticoid [GC] alone; methotrexate [MTX] ± GC; IL1 inhibitor [IL1i] ± GC; IL6 inhibitor [IL6i] ± GC). The primary outcome of clinical inactive disease (CID) without current GC use was assessed at 9 months.
TRIAL REGISTRATION: clinicaltrials.gov NCT01697254; first registered 9/28/12 (retrospectively enrolled).
RESULTS: Thirty patients were enrolled at 13 sites; eight patients were started on a non-biologic CTP (2 GC, 6 MTX) and 22 patients on a biologic CTP (12 IL1i, 10 IL6i) at disease onset. Demographic and disease features were similar between CTP groups. CTP choice appeared to segregate by site preference. CID off GC was achieved by 37% (11 of 30) including 11/22 (50%) starting a biologic CTP compared to 0/8 starting a non-biologic CTP (p = 0.014). There were four serious adverse events: two infections, one appendicitis and one macrophage activation syndrome.
CONCLUSIONS: The CARRA systemic JIA CTP pilot study demonstrated successful implementation of CTPs using the CARRA registry infrastructure. Having demonstrated feasibility, a larger study using CTP response to better determine the relative effectiveness of treatments for new-onset systemic JIA is now underway.
Journal Title
Pediatr Rheumatol Online J
Volume
15
Issue
1
First Page
23
Last Page
23
MeSH Keywords
Adolescent; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antirheumatic Agents; Arthritis, Juvenile; Child; Child, Preschool; Consensus; Drug Therapy, Combination; Feasibility Studies; Female; Glucocorticoids; Humans; Interleukin 1 Receptor Antagonist Protein; Male; Methotrexate; Pilot Projects; Practice Guidelines as Topic; Prospective Studies; Registries; Rheumatology; Treatment Outcome
Keywords
Biologic response modifiers; Comparative effectiveness; Pediatric rheumatology; Registries; Still’s disease; Systemic Juvenile Idiopathic Arthritis
Recommended Citation
Kimura Y, Grevich S, Beukelman T, et al. Pilot study comparing the Childhood Arthritis & Rheumatology Research Alliance (CARRA) systemic Juvenile Idiopathic Arthritis Consensus Treatment Plans. Pediatr Rheumatol Online J. 2017;15(1):23. Published 2017 Apr 11. doi:10.1186/s12969-017-0157-1
Included in
Pediatrics Commons, Rheumatology Commons, Therapeutics Commons
Comments
Secondary source ID
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Publisher's Link: https://ped-rheum.biomedcentral.com/articles/10.1186/s12969-017-0157-1