title: Continuation of methotrexate resulted in better clinical and radiographic outcomes than discontinuation upon starting etanercept in patients with rheumatoid arthritis: 52-week results from the JESMR study.
abstract: OBJECTIVE
  The aim of the Efficacy and Safety of Etanercept on Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan (JESMR) study is to compare the efficacy of continuation versus discontinuation of methotrexate (MTX) when starting etanercept (ETN) in patients with active rheumatoid arthritis (RA).
  
  
  METHODS
  In total, 151 patients with active RA who had been taking MTX were randomized to either ETN 25 mg twice a week with 6-8 mg/week MTX (the E+M group), or ETN alone (the E group). The primary endpoint at Week 52 was the radiographic progression assessed by van der Heijde-modified Sharp score.
  
  
  RESULTS
  The mean progression in total score at Week 52 was not significantly different, statistically, between the E+M group and the E group (0.8 vs 3.6, respectively; p = 0.06). However, a significant difference was observed in radiographic progression between Weeks 24 and 52 (0.3 vs 2.5; p = 0.03), and the mean progression of the erosion score was negative in the E+M group, which was significantly better than the E group at Week 52 (-0.2 vs 1.8; p = 0.02). Clinically, the cumulative probability plot of the American College of Rheumatology (ACR)-N values at Week 52 clearly demonstrated a superior response in the E+M group than in the E group. ACR20, 50, and 70 response rates at Week 52 in the E+M group (86.3%, 76.7%, and 50.7%) were significantly greater than those in the E group (63.8%; p = 0.003, 43.5%; p < 0.0001 and 29.0%; p = 0.01, respectively).
  
  
  CONCLUSIONS
  MTX should be continued when starting ETN in patients with active RA. (ClinicalTrials.gov: NCT00688103).
authors.affiliation: Japan Biological Agent Integrated Consortium (JBASIC), Keio University, Tokyo, Japan. kamehide@z6.keio.jp
authors.forename: Hideto
authors.initials: H
authors.lastname: Kameda
authors.forename: Katsuaki
authors.initials: K
authors.lastname: Kanbe
authors.forename: Eri
authors.initials: E
authors.lastname: Sato
authors.forename: Yukitaka
authors.initials: Y
authors.lastname: Ueki
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Saito
authors.forename: Shouhei
authors.initials: S
authors.lastname: Nagaoka
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Hidaka
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Atsumi
authors.forename: Michishi
authors.initials: M
authors.lastname: Tsukano
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Kasama
authors.forename: Shunichi
authors.initials: S
authors.lastname: Shiozawa
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Hisashi
authors.initials: H
authors.lastname: Yamanaka
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
mesh_terms: D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging* / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D018450:Disease Progression; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000627:therapeutic use*; D008727:Methotrexate / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies; D011859:Radiography; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept; D008727:Methotrexate