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Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan

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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer-Verlag 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3505492/
https://www.ncbi.nlm.nih.gov/pubmed/23053683
http://dx.doi.org/10.1007/s10067-012-2082-5
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author 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
author_facet 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
author_sort Imagawa, Tomoyuki
collection PubMed
description 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/m(2) 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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spelling pubmed-35054922012-11-28 Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan 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 Clin Rheumatol Original Article 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/m(2) 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. Springer-Verlag 2012-10-02 2012 /pmc/articles/PMC3505492/ /pubmed/23053683 http://dx.doi.org/10.1007/s10067-012-2082-5 Text en © The Author(s) 2012 https://creativecommons.org/licenses/by/4.0/ This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Article
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
Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan
title Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan
title_full Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan
title_fullStr Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan
title_full_unstemmed Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan
title_short Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan
title_sort efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in japan
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3505492/
https://www.ncbi.nlm.nih.gov/pubmed/23053683
http://dx.doi.org/10.1007/s10067-012-2082-5
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