Randomized comparison of etanercept with usual therapy in an Asian population with active rheumatoid arthritis: the APPEAL trial
International Journal of Rheumatic Diseases, 05/02/2012
Kim HY et al. – In this Asia–Pacific population of subjects with moderate to severe Rheumatoid arthritis (RA), etanercept (ETN) + methotrexate (MTX) showed superior efficacy versus usual DMARD + MTX regimens, with similar safety profiles.
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 16 weeks.
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.
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