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Title :Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis : results from a phase III open-label study
Authors :Hara, Ryoki
Umebayashi, Hiroaki
Takei, Syuji
Okamoto, Nami
Iwata, Naomi
Yamasaki, Yuichi
Nakagishi, Yasuo
Kizawa, Toshitaka
Kobayashi, Ichiro
Imagawa, Tomoyuki
Kinjo, Noriko
Amano, Norihito
Takahashi, Yoko
Mori, Masaaki
Itoh, Yasuhiko
Yokota, Shumpei
Issue Date :30-Apr-2019
Abstract :Background: To investigate efficacy and safety of intravenous abatacept in Japanese patients with active polyarticular-course juvenile idiopathic arthritis (pJIA). Methods: In this phase III, open-label, multicenter, single-arm study, patients with pJIA aged 4–17 years who failed ≥1 biologic or methotrexate received weight-tiered (< 75 kg: 10 mg/kg; 75–100 kg: 750 mg; > 100 kg: 1000 mg) intravenous abatacept at Weeks 0, 2, 4, and every 4 weeks thereafter. The study comprised a short-term period (16 weeks) and ongoing long-term period. Primary endpoint: Week 16 JIA-American College of Rheumatology criteria 30 (JIA-ACR30) response rate. Secondary endpoints/outcomes included Week 16 JIA-ACR50/70/90 response and inactive disease rates, Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), pharmacokinetics, safety, and immunogenicity. Proportions of patients achieving Juvenile Arthritis Disease Activity Score in 27 joints using C-reactive protein (JADAS27-CRP) remission (score < 1) and minimal disease activity (MDA; score < 3.8), were among exploratory endpoints. Results: All 20 patients who received study medication completed the short-term period. During the long-term period, two patients discontinued due to insufficient efficacy or patient decision. Median age and disease duration at baseline were 10.5 and 0.75 years, respectively. Week 16 JIA-ACR30 response rate (primary endpoint) was 90.0% (18/20). JIA-ACR50/70/90 response and inactive disease rates at Week 16 were 75.0% (15/20), 70.0% (14/20), 35.0% (7/20), and 25.0% (5/20), respectively. At Week 52, JIA-ACR30/50/70/90 response and inactive disease rates were observed by 88.9% (16/18), 88.9% (16/18), 83.3% (15/18), 66.7% (12/18) and 44.4% (8/18), respectively. CHAQ-DI improved after Week 12. JADAS27-CRP remission and MDA were achieved by 15.0% (3/20) and 45.0% (9/20) of patients at Week 16, and by 50.0% (9/18) and 78.0% (14/18) of patients at Week 52, respectively. The mean abatacept pre-dose serum concentration was above the target therapeutic exposure (10 μg/ml) from Week 8 through Week 16. All adverse events were of mild/moderate intensity, except for one case of severe gastroenteritis. No deaths, malignancies, or autoimmune disorders were observed. No antidrug antibodies were detected through Week 16; one patient had a positive immunogenic response during the cumulative period. Conclusion: Intravenous abatacept was efficacious and well tolerated in Japanese patients with active pJIA.
URL :https://doi.org/10.1186/s12969-019-0319-4
Type Local :雑誌掲載論文
ISSN :1546-0096
Publisher :BMC
URI :http://hdl.handle.net/20.500.12000/45985
Citation :Pediatric Rheumatology Vol.17
Appears in Collections:Peer-reviewed Journal Articles (Faculty of Medicine)

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