Pediatric rheumatology

Abatacept as Monotherapy and in Combination With Methotrexate in Patients With Juvenile Idiopathic Arthritis: Analysis of 2 Phase III Trials

J RheumatolPublished Post hoc analysis of 2 phase III trials

Authors' conclusion

ABA monotherapy (SC and IV) was effective and well tolerated in children with pcJIA when prior MTX use was ineffective or not tolerated. Treatment effects of ABA appear to be independent of MTX coadministration.

Study context

Population
Children with polyarticular-course JIA (aged 2–17 years) in whom prior methotrexate (MTX) use was ineffective or not tolerated
Participants
310 vs 99
Comparison
Abatacept + MTX vs abatacept monotherapy
  • ABA + MTXn = 310
  • ABA monotherapyn = 99reference
Methodological detailsstratified by MTX use and prior biologic use
  • Stratified by MTX use and prior biologic use

Primary result

As reported in the abstract

Efficacy responses (JIA-ACR and JADAS27-CRP) · 2 years
  • Efficacy responses similar between ABA + MTX and ABA monotherapy and persisted over 2 years
  • Post hoc analysis

Further findings

Clinical response rates by prior biologic use

Similar in biologic-naïve patients and prior biologic users, independent of MTX use

Pharmacokinetics

Similar minimum steady-state trough ABA concentrations between studies
Baseline MTX did not influence ABA clearance and was not a significant predictor of JIA-American College of Rheumatology (JIA-ACR) responses

Original publication

Abatacept as Monotherapy and in Combination With Methotrexate in Patients With Juvenile Idiopathic Arthritis: Analysis of 2 Phase III Trials. J Rheumatol. Published 15 July 2023. doi:10.3899/jrheum.2022-1320

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