Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan
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ORIGINAL ARTICLE
Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan Tomoyuki Imagawa & Syuji Takei & Hiroaki Umebayashi & Kenichi Yamaguchi & Yasuhiko Itoh & Toshinao Kawai & Naomi Iwata & Takuji Murata & Ikuo Okafuji & Mari Miyoshi & Yasuhiro Onoe & Yoshifumi Kawano & Noriko Kinjo & Masaaki Mori & Neelufar Mozaffarian & Hartmut Kupper & Sourav Santra & Gina Patel & Shinichi Kawai & Shumpei Yokota Received: 12 April 2012 / Revised: 1 August 2012 / Accepted: 28 August 2012 / Published online: 2 October 2012 # The Author(s) 2012. This article is published with open access at Springerlink.com
Abstract 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 0.3 mg/dL), n (%) Mean (SD), mg/dL CHAQ (0–3), mean (SD) PhGA (0–100 mm), mean (SD) PaGA (0–100 mm), mean (SD)
With MTX (N020)
Without MTX (N05)
All adalimumab (N025)
13.2 (3.22) 9 (45) 11 (55) 15 (75)
12.6 (4.39) 3 (60) 2 (40) 5 (100)
13.0 (3.38) 12 (48) 13 (52) 20 (80)
40.5 (11.28) 14 (70) 4.8 (3.97) 14 (70) 105.5 (135.67) 8.6 (5.65) 12.0 (6.10)
35.3 (16.64) 3 (60) 4.2 (2.75) 3 (60) 8.5 (15.50) 5.8 (2.05) 13.6 (9.32)
39.5 (12.31) 17 (68) 4.7 (3.72) 17 (68) 86.1 (127.19) 8.0 (5.22) 12.3 (6.66)
11 (55)
3 (60)
14 (56)
1.0 (1.32) 0.8 (0.79) 56.5 (18.49) 44.6 (24.84)
3.6 (3.86) 0.7 (1.11) 58.6 (25.83) 48.6 (34.20)
1.5 (2.22) 0.8 (0.84) 56.9 (19.56) 45.4 (26.19)
Clin Rheumatol (2012) 31:1713–1721
1717
Results Patient disposition and duration of treatment A total of 25 children with JIA were treated with adalimumab, of which 20 were receiving concomitant MTX at baseline. Twenty-four patients completed 24 weeks of therapy, including the primary endpoint assessment at week 16, and 22 patients completed up to 60 weeks. The three patients who discontinued the study, all due to lack of efficacy, were in the concomitant MTX group. The average duration of adalimumab treatment through week 60 was 396 days (390 days for patients receiving concomitant MTX at baseline and 421 days for patients without MTX). Baseline demographics and clinical characteristics
Fig. 1 ACR Pedi 30 response rates. a Primary efficacy outcome: ACR Pedi 30 response rates at week 16 of adalimumab therapy (NRI). b ACR Pedi 30 response rates over time with adalimumab therapy (as observed) (black diamond with MTX, grey circle without MTX)
At baseline, the mean age was approximately 13 years, 80 % of the patients were female, and 32 % weighed 3 mg/dL) CRP concentrations. All patients had polyarticular JIA at disease onset, except for one patient (not receiving MTX) who had pauciarticular JIA at disease onset. Baseline PhGA, PaGA, and CHAQ scores were similar between groups. Baseline anti-cyclic citrullinated protein (anti-CCP) antibody concentrations were considerably greater in patie
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