https://scholars.lib.ntu.edu.tw/handle/123456789/545319
標題: | Randomized comparison of etanercept with usual therapy in an Asian population with active rheumatoid arthritis: The APPEAL trial | 作者: | Kim H.-Y. PING-NING HSU Barba M. Sulaiman W. Robertson D. Vlahos B. Khandker R. Nab H. Freundlich B. Koenig A. |
關鍵字: | Asia-Pacific; Efficacy; Etanercept; Rheumatoid arthritis; Safety | 公開日期: | 2012 | 卷: | 15 | 期: | 2 | 起(迄)頁: | 188-196 | 來源出版物: | International Journal of Rheumatic Diseases | 摘要: | Aim: Rheumatoid arthritis (RA) is an important rheumatologic disease in Asia-Pacific countries, as in other parts of the world. However, limited information is available regarding RA therapy in this region. The Asia-Pacific Study in Patients to be Treated With Etanercept or an Alternative Listed DMARD (APPEAL) compared efficacy and safety of etanercept (ETN)+methotrexate (MTX) versus usual disease-modifying anti-rheumatic drugs (DMARDs)+MTX (reflecting regional practice) in subjects with moderate to severe RA from multiple Asia-Pacific countries. Method: In this open-label, active-comparator, parallel-design, multicenter study, subjects (n=300) in the Asia-Pacific region were randomized to ETN+MTX (n=197) or DMARD+MTX (n=103). The primary efficacy endpoint was the American College of Rheumatology (ACR) response (ACR-N) area under the curve (AUC) over 16weeks. Results: Baseline characteristics were similar between groups. At Week 16, ACR-N AUC indicated a significantly greater response with ETN+MTX compared with DMARD+MTX (mean difference -145.3; P<0.001). Significantly greater proportions of subjects achieved ACR 20, 50 and 70 responses with ETN+MTX versus DMARD+MTX at Week 16 (P<0.05). Low Disease Activity Score based on a 28-joint count (DAS28<3.2) was also achieved by significantly more subjects in the ETN+MTX group versus the DMARD+MTX group (P<0.001). Greater improvements were shown for DAS28, pain visual analogue scale, health assessment questionnaire, and physician and patient global assessments (P<0.05) for ETN+MTX versus DMARD+MTX. No new safety signals were found. Conclusion: In this Asia-Pacific population of subjects with moderate to severe RA, ETN+MTX showed superior efficacy versus usual DMARD+MTX regimens, with similar safety profiles. ? 2011 The Authors. International Journal of Rheumatic Diseases ? 2011 Asia Pacific League of Associations for Rheumatology and Blackwell Publishing Asia Pty Ltd. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84859268784&doi=10.1111%2fj.1756-185X.2011.01680.x&partnerID=40&md5=3ace542ae52a0fb018fd2e89cda4f8c7 https://scholars.lib.ntu.edu.tw/handle/123456789/545319 |
ISSN: | 1756-1841 | DOI: | 10.1111/j.1756-185X.2011.01680.x | SDG/關鍵字: | etanercept; hydroxychloroquine; leflunomide; methotrexate; salazosulfapyridine; adult; aged; area under the curve; article; Asian; controlled study; disease activity; drug efficacy; drug withdrawal; female; gastrointestinal disease; Health Assessment Questionnaire; heart disease; human; infection; infestation; intoxication; major clinical study; male; multicenter study; parallel design; phase 4 clinical trial; physician; population; priority journal; randomized controlled trial; rheumatoid arthritis; side effect; United States; visual analog scale; Adolescent; Adult; Aged; Antirheumatic Agents; Area Under Curve; Arthritis, Rheumatoid; Asia; Asian Continental Ancestry Group; Drug Therapy, Combination; Female; Humans; Immunoglobulin G; Male; Methotrexate; Middle Aged; Pacific Islands; Receptors, Tumor Necrosis Factor; Treatment Outcome; Young Adult |
顯示於: | 醫學系 |
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