| 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. | |
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MedLine Citation:
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PMID: 22196469 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Journal Article Date: 2011-11-25 |
Journal Detail:
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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:
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Created Date: 2011-12-26 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101174817 Medline TA: J Chin Med Assoc Country: China (Republic : 1949- ) |
Other Details:
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Languages: eng Pagination: 544-51 Citation Subset: IM |
Copyright Information:
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Copyright © 2011. Published by Elsevier B.V. |
Affiliation:
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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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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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