PMID- 32552266
OWN - NLM
STAT- MEDLINE
DCOM- 20210507
LR  - 20220419
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 31
IP  - 1
DP  - 2021 Jan
TI  - Efficacy and safety of canakinumab in systemic juvenile idiopathic arthritis: 
      48-week results from an open-label phase III study in Japanese patients.
PG  - 226-234
LID - 10.1080/14397595.2020.1783163 [doi]
AB  - OBJECTIVES: To assess the efficacy and safety of canakinumab in Japanese patients 
      with systemic juvenile idiopathic arthritis (sJIA). METHODS: This was an 
      open-label, single-arm active treatment study. sJIA patients, aged >/=2 to <20 
      years, were administered canakinumab 4 mg/kg every 4 weeks for </=48 weeks. The 
      co-primary endpoints were the proportion of patients who achieved an adapted 
      American College of Rheumatology pediatric (ACR pedi) 30 criteria at week 8, and 
      the proportion of patients who successfully tapered corticosteroids at week 28. 
      Herein, the efficacy and safety results up to 48 weeks are reported. RESULTS: Of 
      the 19 patients enrolled, 15 (78.9%) had previously used tocilizumab. All 
      patients achieved ACR pedi 30 at week 8 and 73.7% (14/19) successfully tapered 
      corticosteroids at week 28. At week 48, ACR pedi 50/70/90/100 responses were 
      achieved by 100.0%/100.0%/87.5%/68.8% of patients. The most common adverse events 
      (AEs) were infections (271.6 patient-years), 42.1% (8/19) patients had serious 
      AEs. Two potential cases of macrophage activation syndrome were identified. No 
      deaths were reported. CONCLUSION: Canakinumab was efficacious in Japanese 
      patients with sJIA and was associated with substantial corticosteroid dose 
      reduction in the majority of patients. The safety profile of canakinumab was 
      consistent with that observed from previous studies. CLINICALTRIALS.GOV 
      (IDENTIFIER: NCT02396212).
FAU - Nishimura, Kenichi
AU  - Nishimura K
AD  - Department of Pediatrics, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Hara, Ryoki
AU  - Hara R
AD  - Department of Pediatrics, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Umebayashi, Hiroaki
AU  - Umebayashi H
AD  - Department of Rheumatology and Infectious Disease, Miyagi Children's Hospital, 
      Sendai, Japan.
FAU - Takei, Syuji
AU  - Takei S
AD  - School of Medical and Dental Sciences Pediatrics, Kagoshima University Graduate, 
      Kagoshima, Japan.
FAU - Iwata, Naomi
AU  - Iwata N
AD  - Department of Infection and Immunology, Aichi Children's Health and Medical 
      Center, Obu, Japan.
FAU - Imagawa, Tomoyuki
AU  - Imagawa T
AD  - Department of Infection and Immunology, Kanagawa Children's Medical Center, 
      Yokohama, Japan.
FAU - Shimizu, Masaki
AU  - Shimizu M
AD  - Department of Pediatrics, Kanazawa University Hospital, Kanazawa, Japan.
FAU - Tomiita, Minako
AU  - Tomiita M
AD  - Department of Pediatrics, Pediatric Allergy and Rheumatology Center, National 
      Hospital Organization Shimoshizu National Hospital, Chiba, Japan.
FAU - Seko, Noriko
AU  - Seko N
AD  - Novartis Pharma KK, Tokyo, Japan.
FAU - Kitawaki, Tetsuji
AU  - Kitawaki T
AD  - Novartis Pharma KK, Tokyo, Japan.
FAU - Yokota, Shumpei
AU  - Yokota S
AD  - Children's Intractable Disease Rheumatism Center, Fuji Toranomon Orthopedics 
      Hospital, Shizuoka, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT02396212
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20200729
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 37CQ2C7X93 (canakinumab)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Arthritis, Juvenile/*drug therapy
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Male
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Canakinumab
OT  - corticosteroid tapering
OT  - interleukin-1beta
OT  - macrophage activation syndrome
OT  - systemic juvenile idiopathic arthritis
EDAT- 2020/06/20 06:00
MHDA- 2021/05/08 06:00
CRDT- 2020/06/20 06:00
PHST- 2020/06/20 06:00 [pubmed]
PHST- 2021/05/08 06:00 [medline]
PHST- 2020/06/20 06:00 [entrez]
AID - 10.1080/14397595.2020.1783163 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2021 Jan;31(1):226-234. doi: 10.1080/14397595.2020.1783163. Epub 
      2020 Jul 29.