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.Methods
- 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.
- No new safety signals were found.