Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan.
Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan.
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DOI：
10.1007/s10067-012-2082-5
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发表时间：
2012-12
影响因子：
3.4
通讯作者：
Yokota, Shumpei
中科院分区：
文献类型：
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作者：
Imagawa, Tomoyuki;Takei, Syuji;Umebayashi, Hiroaki;Yamaguchi, Kenichi;Itoh, Yasuhiko;Kawai, Toshinao;Iwata, Naomi;Murata, Takuji;Okafuji, Ikuo;Miyoshi, Mari;Onoe, Yasuhiro;Kawano, Yoshifumi;Kinjo, Noriko;Mori, Masaaki;Mozaffarian, Neelufar;Kupper, Hartmut;Santra, Sourav;Patel, Gina;Kawai, Shinichi;Yokota, Shumpei
本研究旨在评价阿达木单抗在日本多关节型幼年特发性关节炎（JIA）患者中的疗效、药代动力学和安全性。年龄为4 - 17岁的患者入组了一项阿达木单抗的单臂、开放标签、多中心研究。体重<30 kg的患者每隔一周接受20 mg（eow），≥30 kg的患者接受40 mg eow。允许合并甲氨蝶呤（MTX）（≤10 mg/m2/周）。主要疗效结局是第16周时美国风湿病学会儿科30级应答（ACR Pedi 30）的患者百分比。分析了JIA核心变量、血清阿达木单抗浓度和抗阿达木单抗抗体（AAA）。监测患者的不良事件（AE）。入组了25例患者（20例在基线时伴随MTX，5例未伴随MTX）：24例患者完成了16周治疗，22例患者完成了60周治疗。在第16周，90%的MTX组患者和100%的未MTX组患者达到ACR Pedi 30;分别有94%和80%的患者的缓解率维持至第60周。每个JIA核心变量都随着时间的推移而改善。6例患者变为AAA阳性（第8、16和60周各2例），其中一些为一过性。所有6名AAA阳性患者在第16周时均达到ACR Pedi 30，4名患者在第60周时维持该反应。6例患者（均接受MTX治疗）发生了9起严重AE（JIA、发热、关节痛、肺炎、B型肝炎感染、咽炎、脱水、咽痛和肺炎）。在日本的多关节型JIA儿科患者中，阿达木单抗可安全有效地降低疾病活动性长达60周。
The objective of this study was to evaluate the efficacy, pharmacokinetics, and safety of adalimumab in patients with polyarticular juvenile idiopathic arthritis (JIA) in Japan. Patients aged 4 to 17 years were enrolled in a single-arm, open-label, multicentre study of adalimumab. Patients weighing <30 kg received 20 mg every other week (eow), and those ≥30 kg received 40 mg eow. Concomitant methotrexate (MTX) was allowed (≤10 mg/m2 per week). The primary efficacy outcome was the percent of patients with American College of Rheumatology Pediatric 30 response (ACR Pedi 30) at week 16. JIA core variables, serum adalimumab concentrations, and anti-adalimumab antibodies (AAAs) were analysed. Patients were monitored for adverse events (AEs). Twenty-five patients (20 with concomitant MTX at baseline and 5 without) were enrolled: 24 patients completed 16 weeks of therapy and 22 patients completed 60 weeks. At week 16, 90 % of patients with MTX and 100 % without MTX achieved ACR Pedi 30; response rates were maintained through week 60 in 94 and 80 % of patients, respectively. Each JIA core variable improved over time. Six patients became AAA positive (two each at weeks 8, 16, and 60), some of which were transient. All six AAA-positive patients achieved ACR Pedi 30 at week 16, and four maintained that response at week 60. Six patients (all with MTX) experienced nine serious AEs (JIA, pyrexia, arthralgia, pneumonia, hepatitis B infection, pharyngitis, dehydration, pharyngeal pain, and pneumonia). In pediatric patients with polyarticular JIA in Japan, adalimumab was safe and effective for reducing disease activity for up to 60 weeks.
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DOI：
10.1007/s10880-011-9243-6
发表时间：
2011-09-01
影响因子：
2.2
作者：
Feinstein, Amanda B.;Forman, Evan M.;Goldsmith, Donald P.
通讯作者：
Goldsmith, Donald P.
影响因子：
2.2
作者：
Mori, Masaaki;Takei, Syuji;Wajdula, Joseph S.
通讯作者：
Wajdula, Joseph S.
影响因子：
2.2
作者：
Imagawa, Tomoyuki;Yokota, Shumpei;Kishimoto, Tadamitsu
通讯作者：
Kishimoto, Tadamitsu
影响因子：
27.4
作者：
Burmester, G. R.;Mease, P.;Pangan, A. L.
通讯作者：
Pangan, A. L.
DOI：
10.2147/dddt.s16489
发表时间：
2011-01-26
期刊：
Drug design, development and therapy
影响因子：
--
作者：
Goldzweig O;Hashkes PJ
通讯作者：
Hashkes PJ