title: Etanercept (ETN) with methotrexate (MTX) is better than ETN monotherapy in patients with active rheumatoid arthritis despite MTX therapy: a randomized trial.
abstract: The superiority of the combination therapy of methotrexate (MTX) and anti-tumor necrosis factor (TNF) biological agents over anti-TNF monotherapy in MTX-naïve patients with rheumatoid arthritis (RA) has been demonstrated. We investigated the efficacy and safety of continuation versus discontinuation of MTX at the commencement of etanercept (ETN) in patients with active RA despite MTX therapy. In total, 151 patients with active RA despite treatment with MTX were randomized to either ETN 25 mg twice a week and MTX 6-8 mg/week (the E + M group) or ETN alone (the E group). Co-primary endpoints included the European League Against Rheumatism (EULAR) good response rate and the American College of Rheumatology (ACR) 50 response rate at week 24. Demographic and clinical features between groups at baseline were similar. The EULAR good response rates were significantly higher in the E + M group (52%) than in the E group (33%) at week 24 (p = 0.0001). Although the ACR50 response rate, one of the co-primary endpoints, and the ACR70 response rate at week 24 were not significantly greater in the E + M group (64 and 38%, respectively) than in the E group (48 and 26%, respectively), the ACR20 response rate was significantly greater in the E + M group (90%) than in the E group (64%; p = 0.0002). Safety profiles were similar for the groups. Thus, MTX should be continued at the commencement of ETN therapy, even in RA patients who show an inappropriate response to MTX.
authors.affiliation: Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Kawagoe, Japan. kamehide@z6.keio.jp
authors.forename: Hideto
authors.initials: H
authors.lastname: Kameda
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: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D001175:Arthrography; D018450:Disease Progression; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D006304:Health Status; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007596:Joints / Q000503:physiopathology; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D020127:Recovery of Function; D016896:Treatment Outcome; D028761:Withholding Treatment
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept; D008727:Methotrexate