title: Discontinuation of etanercept after achievement of sustained remission in patients with rheumatoid arthritis who initially had moderate disease activity-results from the ENCOURAGE study, a prospective, international, multicenter randomized study.
abstract: OBJECTIVE
  To investigate the efficacy and safety of etanercept (ETN) in patients with rheumatoid arthritis (RA) with moderate disease activity and the possibility to discontinue ETN after achieving remission.
  
  
  METHODS
  Multicenter, randomized, and open-label study was conducted in Japan and Korea. RA patients (disease duration <5 years) with moderate disease activity despite methotrexate (MTX) treatment were allocated to either MTX or ETN + MTX (Period 1) for 12 months. Patients who achieved sustained remission defined as DAS28 < 2.6 at both 6 and 12 months in the ETN + MTX group, were randomized to either continue or discontinue ETN for 12 months (Period 2).
  
  
  RESULTS
  A total of 222 patients were enrolled in Period 1 and clinical remission was achieved in 106/157 (67.5%) and 5/28 (17.9%) patients in the ETN + MTX and MTX groups, respectively. In Period 2, sixty-seven patients were randomized and finally 28/32 (87.5%) and 15/28 (53.6%) patients who continued or discontinued ETN maintained clinical remission. Baseline disease activity and the presence of comorbid diseases influenced the maintenance of remission after ETN discontinuation.
  
  
  CONCLUSIONS
  ETN + MTX was efficient for RA patients with moderate disease activity into remission. After achieving sustained remission, a half of the patients who discontinued ETN could maintain remission for 1 year.
authors.affiliation: a Institute of Rheumatology, Tokyo Women's Medical University , Japan .
authors.forename: Hisashi
authors.initials: H
authors.lastname: Yamanaka
authors.affiliation: b Internal Department of Rheumatology , Yokohama Minami Kyosai Hospital , Japan .
authors.forename: Shouhei
authors.initials: S
authors.lastname: Nagaoka
authors.affiliation: c Department of Rheumatology , Yonsei University College of Medicine , Korea .
authors.forename: Soo-Kon
authors.initials: SK
authors.lastname: Lee
authors.affiliation: d Hanyang University Hospital for Rheumatic Diseases , Korea .
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Bae
authors.affiliation: e Department of Rheumatology , Showa University Hospital , Japan .
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Kasama
authors.affiliation: f Department of Internal Medicine , Itabashi Chuo Medical Center , Japan .
authors.forename: Hitomi
authors.initials: H
authors.lastname: Kobayashi
authors.affiliation: g Department of Rheumatism , Nishioka Clinic for Rheumatic Diseases and Allergic Diseases , Japan .
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Nishioka
authors.affiliation: h Rheumatic Diseases Center , Sasebo Chuo Hospital , Japan .
authors.forename: Yukitaka
authors.initials: Y
authors.lastname: Ueki
authors.affiliation: a Institute of Rheumatology, Tokyo Women's Medical University , Japan .
authors.forename: Yohei
authors.initials: Y
authors.lastname: Seto
authors.affiliation: i Department of Internal Medicine and Rheumatology , Nishinarita Clinic , Japan .
authors.forename: Makoto
authors.initials: M
authors.lastname: Nishinarita
authors.affiliation: j Department of Internal Medicine and Rheumatology , Juntendo University Faculty of Medicine , Japan .
authors.forename: Naoto
authors.initials: N
authors.lastname: Tamura
authors.affiliation: k Division of Rheumatology , Department of Internal Medicine Keio University School of Medicine , Japan .
authors.forename: Noriko
authors.initials: N
authors.lastname: Kimura
authors.affiliation: l The 1st Department of Internal Medicine , School of Medicine University of Occupational & Environmental Health , Japan .
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Saito
authors.affiliation: m Department of Orthopedic Surgery , Osaka University Hospital , Japan .
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Tomita
authors.affiliation: n Center for Rheumatic Diseases , Chibaken Saiseikai Narashino Hospital , Japan .
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Nawata
authors.affiliation: o Department of Connecting Tissue Disease , Shinonoi General Hospital , Japan .
authors.forename: Sadahiro
authors.initials: S
authors.lastname: Suzuki
authors.affiliation: p Rheumatology, Hematology, Infectious Diseases , Yokohama City University Hospital , Japan .
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Ishigatsubo
authors.affiliation: q Internal Medicine, Rheumatology , Taihakusakura Hospital , Japan .
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Munakata
authors.affiliation: r The 2nd Department of Internal Medicine , Asahikawa Medical University Hospital , Japan , and.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Makino
authors.affiliation: s Division of Biostatistics , National Center for Child Health and Development , Japan.
authors.forename: Eisuke
authors.initials: E
authors.lastname: Inoue
authors.affiliation: l The 1st Department of Internal Medicine , School of Medicine University of Occupational & Environmental Health , Japan .
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: k Division of Rheumatology , Department of Internal Medicine Keio University School of Medicine , Japan .
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D000068800:Etanercept / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies; D012074:Remission Induction / Q000379:methods*; D056910:Republic of Korea; D012720:Severity of Illness Index; D016896:Treatment Outcome; D028761:Withholding Treatment
chemical_list: D018501:Antirheumatic Agents; D000068800:Etanercept; D008727:Methotrexate
keywords: Clinical trial; Discontinuation; Etanercept; Remission; Rheumatoid arthritis