Efficacy and Safety of Canakinumab in Patients with Still's Disease: Exposure-Response Analysis of Pooled Systemic Juvenile Idiopathic Arthritis Data by Age Groups - Sorbonne Université Access content directly
Journal Articles Clinical and Experimental Rheumatology Year : 2018

Efficacy and Safety of Canakinumab in Patients with Still's Disease: Exposure-Response Analysis of Pooled Systemic Juvenile Idiopathic Arthritis Data by Age Groups

Pierre Quartier
Rayfel Schneider
  • Function : Author
Paolo Sfriso
  • Function : Author
Petros Efthimiou
  • Function : Author
Luca Cantarini
  • Function : Author
Karine Lheritier
  • Function : Author
Karolynn Leon
  • Function : Author
Chetan S. Karyekar
  • Function : Author
Antonio Speziale
  • Function : Author

Abstract

OBJECTIVES: To describe the efficacy, safety, and exposure-response relationship of canakinumab in a subgroup of patients with systemic juvenile idiopathic arthritis (SJIA) aged ≥q16 years, representative of adult-onset Still's disease (AOSD) patients, and to compare this subgroup with those of children and young adolescents with SJIA by pooling clinical data collected during the development programme of canakinumab. METHODS: Safety and efficacy data on canakinumab-treated patients were pooled from 4 SJIA studies (NCT00426218, NCT00886769, NCT00889863, and NCT00891046). In the majority of patients, canakinumab was administered at 4 mg/kg every 4 weeks. Efficacy parameters (adapted American College of Rheumatology [aACR] paediatric and juvenile idiopathic arthritis [JIA] ACR responses), quality of life, C-reactive protein levels, safety, and exposure-response relationship were assessed over 12 weeks in 3 age groups (children 2-<12, young adolescents 12-<16 and older adolescents and young adults ≥q16 years). RESULTS: Efficacy outcomes were analysed in 216 children, 56 young adolescents and 29 older adolescents and young adults. Efficacy parameters across 3 age groups were largely comparable. At Day 15, at least 50% of patients from each age group exhibited aACR ≥q70 and ACR responses. The safety profile of canakinumab was similar across age groups. One death was reported. CONCLUSIONS: Pooled analyses from SJIA studies indicate that older adolescents and young adults SJIA patients show similar efficacy, safety, and exposure-response relationship on a weight-based dosing regimen as observed in children and adolescent SJIA patients. These analyses suggest that canakinumab may be an effective therapy in young adults with Still's disease.
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Dates and versions

hal-03849939 , version 1 (12-11-2022)

Identifiers

  • HAL Id : hal-03849939 , version 1
  • PUBMED : 29533755

Cite

Eugen Feist, Pierre Quartier, Bruno Fautrel, Rayfel Schneider, Paolo Sfriso, et al.. Efficacy and Safety of Canakinumab in Patients with Still's Disease: Exposure-Response Analysis of Pooled Systemic Juvenile Idiopathic Arthritis Data by Age Groups. Clinical and Experimental Rheumatology, 2018, 36 (4), pp.668--675. ⟨hal-03849939⟩
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