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A multicenter open-label phase I/II study to assess the safety, tolerability, and efficacy of three dose levels of TuNEX in patients with rheumatoid arthritis.
MedLine Citation:
PMID:  22196469     Owner:  NLM     Status:  In-Data-Review    
BACKGROUND: Tumor necrosis factor (TNF)-α is a pivotal inflammatory cytokine in the pathogenesis of rheumatoid arthritis (RA). TuNEX, a recombinant TNF-α receptor protein, can effectively bind TNF-α. The purpose of this phase I/II dose-escalation study was to assess the safety and preliminary efficacy of three dose levels of TuNEX in Taiwanese patients with RA.
METHODS: Eighteen patients with active RA from three medical centers who had failed previous therapy with at least one disease modifying antirheumatic drug (DMARD) were enrolled. The primary efficacy endpoint was a 20% improvement in the American College of Rheumatology criteria (ACR20) in the fourth week. The occurrence of treatment-emergent adverse events (TEAEs) was the primary safety variable.
RESULTS: The highest percentage of TuNEX 25-mg- and 35-mg-treated patients achieved an ACR20 response (60% and 100%, respectively) for the first time at Week 2 during the 4-week treatment period. There was a strong trend toward a superior ACR20 response rate in the TuNEX 15-mg group (83.3%) in comparison with the TuNEX 25-mg group (40.0%) and the TuNEX 35-mg group (50.0%) at week 4. Patients who received 15-mg TuNEX, 25-mg TuNEX, and 35-mg TuNEX had 35.99%, 16.85%, and 21.86% reduction of disability indices of Health Assessment Questionnaire after drug treatment, respectively. The most commonly reported adverse event was injection-site reaction. The TEAEs were comparable between the three TuNEX-treated groups.
CONCLUSION: TuNEX reduced the signs and symptoms of RA and improved physical function, with clinically acceptable safety and tolerability in patients who had previously received DMARDs.
Der-Yuan Chen; Ning-Sheng Lai; Ling-Ying Lu; Hsiu-Cheng Chou; Yi-Hsing Chen; Tsu-Yi Hsieh; Yi-Ming Chen; Joung-Liang Lan
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Publication Detail:
Type:  Journal Article     Date:  2011-11-25
Journal Detail:
Title:  Journal of the Chinese Medical Association : JCMA     Volume:  74     ISSN:  1728-7731     ISO Abbreviation:  J Chin Med Assoc     Publication Date:  2011 Dec 
Date Detail:
Created Date:  2011-12-26     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101174817     Medline TA:  J Chin Med Assoc     Country:  China (Republic : 1949- )    
Other Details:
Languages:  eng     Pagination:  544-51     Citation Subset:  IM    
Copyright Information:
Copyright © 2011. Published by Elsevier B.V.
Division of Allergy, Immunology, and Rheumatology, Taichung Veterans General Hospital, Taichung, Taiwan, ROC; Faculty of Medicine, National Yang-Ming University School of Medicine, Taipei, Taiwan, ROC; School of Medicine, Chung-Shan Medical University, Taichung, Taiwan, ROC.
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