title: Randomized comparison of etanercept with usual therapy in an Asian population with active rheumatoid arthritis: the APPEAL trial.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Rheumatism Research Center, Catholic University of Korea, Seoul St. Mary's Hospital, Seoul. ho0919@catholic.ac.kr
authors.forename: Ho-Youn
authors.initials: HY
authors.lastname: Kim
authors.forename: Ping-Ning
authors.initials: PN
authors.lastname: Hsu
authors.forename: Merle
authors.initials: M
authors.lastname: Barba
authors.forename: Wahinnuddin
authors.initials: W
authors.lastname: Sulaiman
authors.forename: Debbie
authors.initials: D
authors.lastname: Robertson
authors.forename: Bonnie
authors.initials: B
authors.lastname: Vlahos
authors.forename: Rezaul
authors.initials: R
authors.lastname: Khandker
authors.forename: Henk
authors.initials: H
authors.lastname: Nab
authors.forename: Bruce
authors.initials: B
authors.lastname: Freundlich
authors.forename: Andrew
authors.initials: A
authors.lastname: Koenig
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D019540:Area Under Curve; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D001208:Asia / Q000453:epidemiology; D044466:Asian People / Q000208:ethnology; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D010139:Pacific Islands / Q000453:epidemiology; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept; D008727:Methotrexate