Abstract
Efficacy, safety, and pharmacokinetics results from 4 studies—3 open-label (OL) and 1 randomized double-blind (DB)—have provided data for approval of etanercept for treatment of disease-modifying anti-rheumatic drug (DMARD)-refractory juvenile idiopathic arthritis (JIA) in Japan. Results from the 3 shorter-term (2 OL and 1 DB) studies are reported here. Subjects (4–17 years) enrolled in the OL studies had active JIA, i.e. ≥5 swollen joints and ≥3 joints with limitation of motion and pain or tenderness. Subjects enrolled in the primary OL study received etanercept 0.4 mg/kg subcutaneously twice weekly; in the lower-dose OL study subjects received etanercept 0.2 mg/kg. Subjects in the primary OL study who completed ≥48 weeks could continue into a 12-week DB dose-down extension study in which subjects received etanercept 0.4 or 0.2 mg/kg twice weekly. The primary endpoint in all 3 studies, i.e. 30% improvement in the American College of Rheumatology criteria for JIA (ACR Pedi 30) at 12 weeks, was achieved by ≥80% of subjects by week 2 and sustained to week 12. Common adverse events reported were injection site reactions, nasopharyngitis, and gastroenteritis. These results provide further evidence that etanercept is effective therapy for DMARD-refractory polyarticular JIA patients.
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Notes
The 3 studies presented in this article were initiated before 27 September 2007 and completed before 26 December 2007 and were therefore not subject to the new requirements for clinical trial results registration (Clinicaltrials.gov). The primary study (including data by 104 weeks) was initiated on 23 October 2003 and completed on 26 December 2005. The dose-down extension study was initiated 20 October 2005 and completed on 29 May 2006. The lower dose study was initiated 20 October 2005 and completed 13 March 2006.
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Acknowledgments
The authors meet the authorship criteria of the International Committee of Medical Journal Editors (ICMJE), were involved in all stages of manuscript development, and were responsible for the manuscript’s content. The authors received no compensation related to the development of the manuscript. Medical writing support for this manuscript was provided by Ruth Pereira, PhD, of the External Medical Communications Department at Pfizer, Inc. We wish to thank all patients who participated in the trials, and investigators and medical staff of the participating centers, Yokohama City University School of Medicine and Kagoshima University School of Medicine. This study was sponsored by Wyeth, which was acquired by Pfizer Inc in October 2009.
Conflict of interest
Syuji Takei received a research fund from Takeda Pharmaceutical Company Limited. Joseph Wajdula and Tracey Fletcher are employees of Pfizer, Inc. Pfizer, Inc. was the sponsor of the clinical trials discussed in this manuscript. All other authors have declared no conflicts of interest.
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Mori, M., Takei, S., Imagawa, T. et al. Etanercept in the treatment of disease-modifying anti-rheumatic drug (DMARD)-refractory polyarticular course juvenile idiopathic arthritis: experience from Japanese clinical trials. Mod Rheumatol 21, 572–578 (2011). https://doi.org/10.1007/s10165-011-0450-7
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DOI: https://doi.org/10.1007/s10165-011-0450-7