Eugen Feist1, Pierre Quartier2, Bruno Fautrel3, Rayfel Schneider4, Paolo Sfriso5, Petros Efthimiou6, Luca Cantarini7, Karine Lheritier8, Karolynn Leon9, Chetan S Karyekar9, Antonio Speziale8. 1. Charité-Universitätsmedizin, Berlin, Germany. 2. Paris-Descartes University, IMAGINE Institute, Necker-Enfants Malades Hospital, Assistance Publique Hopitaux de Paris, France. 3. UPMC-GRC 08, Pierre Louis Institute of Epidemiology and Public Health, Paris; AP-HP, Pitie Salpetriere Hospital, Rheumatology Department, Paris, France. 4. University of Toronto and The Hospital for Sick Children, Toronto, Canada. 5. University of Padova, Italy. 6. New York University School of Medicine, New York, USA. 7. University of Siena, Italy. 8. Novartis Pharma AG, Basel, Switzerland. 9. Novartis Pharmaceuticals Corporation, East Hanover, USA.
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 ≥16 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 ≥16 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 ≥70 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.
OBJECTIVES: To describe the efficacy, safety, and exposure-response relationship of canakinumab in a subgroup of patients with systemic juvenile idiopathic arthritis (SJIA) aged ≥16 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 ≥16 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 ≥70 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.
Authors: Claudia Kedor; Joachim Listing; Jan Zernicke; Anja Weiß; Frank Behrens; Norbert Blank; Joerg Christoph Henes; Joern Kekow; Andrea Rubbert-Roth; Hendrik Schulze-Koops; Eva Seipelt; Christof Specker; Eugen Feist Journal: Ann Rheum Dis Date: 2020-05-13 Impact factor: 27.973